Developing an Internet-Delivered Sexual Health Program for Breast Cancer Survivors, SHINE Trial (SHINE)

February 13, 2026 updated by: Wake Forest University Health Sciences

Optimizing Psychosocial Intervention for Breast Cancer-Related Sexual Morbidity:The Sexual Health and Intimacy Education (SHINE) Trial

The goal of this clinical trial is to develop an effective internet-delivered program to help breast cancer survivors manage cancer-related sexual concerns.

This study is being done to find out if the study approach is better or worse than the usual approach to helping breast cancer survivors manage cancer-related sexual concerns. The usual approach is defined as care most cancer survivors get for their cancer-related sexual concerns.

Participants will complete a questionnaire and if they qualify, they will be assigned to one of sixteen groups of participants. Groups will get access to various kinds of help through an Internet-delivered program called SHINE, which was designed and is run by researchers at the University of Virginia Center for Behavioral Health and Technology. All groups will get access to education about sexual health after cancer: either a standard education website or an enhanced education web program. Groups may also receive up to three additional web programs on: talking to your clinicians about sexual concerns, and/or talking to your partner about sexual concerns, and/or increasing intimacy. Participants are asked to complete the SHINE program within 12 weeks.

After participants finish this 12-week period, the study team will ask them to complete a questionnaire to check in with the participant. The participant will be asked one additional time 12 weeks later to complete another questionnaire to see how the participant is doing. A participant will be in the study for 24 weeks.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study has sixteen study groups with about twenty people in each group. Different groups receive different combinations of help. Participants will receive a certain combination of these four different Cores to make up their SHINE program. A Core is equal to one 20-45-minute lesson. Participants will receive access to all assigned Cores at one time. Participants can complete them at their own pace, as the SHINE program allows them to return where they left off. The four Cores are described below:

  • Education Core: A one-time education about sexual health after breast cancer by either a traditional webpage or by a web-based program. In the traditional webpage, a participant can read and review the information at their own pace. In the web-based program, a participant can also read and review the information at their own pace, and the information will be presented with interactive activities and email reminders. This one-time lesson should take the participant 20-45 minutes to complete.
  • Talking with a Clinicians Core: A participant may receive access to a web-based program about how to talk with their health care team about their sexual concerns. A participant can use this program at their own pace, and it will have information, activities, and email reminders. This one-time lesson should take a participant approximately 45 minutes to complete.
  • Talking with a Partner Core: A participant may receive access to a web-based program about how to talk with their partner about their sexual concerns. A participant can use this program at their own pace, and it will have information, activities, and email reminders. This one-time lesson should take a participant approximately 45 minutes to complete.
  • Intimacy Enhancement Core: A participant may receive access to a web-based program about how to increase their physical and emotional closeness with their partner. A participant can use this program at their own pace, and it will have information, activities, and email reminders. This one-time lesson should take the participant approximately 45 minutes to complete.

Before you begin the study, your medical team will review your medical record. This helps your medical team decide if it is safe for you to take part in the study. If you join the study, you will have the usual care you would get even if you were not in the study.

If you choose to take part in this study, you will be asked to fill out forms with questions about your sexual concerns, function, symptoms, and experiences, as well as relationship satisfaction and intimacy. In addition, you will be asked about your communication about sexual concerns with your medical team and partner. Finally, you will be asked for your thoughts about the SHINE program, and a little about your demographics, distress, daily lifestyle, physical activity, and tobacco use. Researchers will use this information to determine what combination of kinds of help delivered by the internet is best for breast cancer patients to better understand and address their sexual concerns.

Participants will be asked to fill out questionnaires electronically from a link that is emailed to them three separate times during the study:

  • After a participant consents, before they can be randomized to a study group.
  • Approximately 12 weeks after the participant completes the first questionnaire.
  • Approximately 24 weeks after the participant completes the first questionnaire.

Each questionnaire will take about 40 to 45 minutes to complete. Participants may skip any question for any reason.

Study Type

Interventional

Enrollment (Actual)

340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Cancer Center at Saint Joseph's
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Mercy Hospital Fort Smith
    • California
      • Antioch, California, United States, 94531
        • Kaiser Permanente-Deer Valley Medical Center
      • Dublin, California, United States, 94568
        • Kaiser Permanente Dublin
      • Fremont, California, United States, 94538
        • Kaiser Permanente-Fremont
      • Fresno, California, United States, 93720
        • Kaiser Permanente-Fresno
      • Modesto, California, United States, 95356
        • Kaiser Permanente-Modesto
      • Oakland, California, United States, 94611
        • Kaiser Permanente-Oakland
      • Redwood City, California, United States, 94063
        • Kaiser Permanente- Marshall Medical Offices
      • Richmond, California, United States, 94801
        • Kaiser Permanente-Richmond
      • Roseville, California, United States, 95661
        • Kaiser Permanente-Roseville
      • Sacramento, California, United States, 95814
        • Kaiser Permanente Downtown Commons
      • Sacramento, California, United States, 95823
        • Kaiser Permanente-South Sacramento
      • San Francisco, California, United States, 94115
        • Kaiser Permanente-San Francisco
      • San Jose, California, United States, 95119
        • Kaiser Permanente-Santa Teresa-San Jose
      • San Leandro, California, United States, 94577
        • Kaiser Permanente San Leandro
      • San Rafael, California, United States, 94903
        • Kaiser San Rafael-Gallinas
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Rosa, California, United States, 95403
        • Kaiser Permanente-Santa Rosa
      • Santa Rosa, California, United States, 95403
        • Providence Medical Foundation - Santa Rosa
      • Santa Rosa, California, United States, 95405
        • Providence Santa Rosa Memorial Hospital
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente-South San Francisco
      • Stockton, California, United States, 95210
        • Kaiser Permanente-Stockton
      • Vacaville, California, United States, 95688
        • Kaiser Permanente Medical Center-Vacaville
      • Vallejo, California, United States, 94589
        • Kaiser Permanente-Vallejo
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente-Walnut Creek
    • Delaware
      • Frankford, Delaware, United States, 19945
        • Beebe South Coastal Health Campus
      • Newark, Delaware, United States, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, United States, 19713
        • Medical Oncology Hematology Consultants PA
      • Rehoboth Beach, Delaware, United States, 19971
        • Beebe Health Campus
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
      • Washington D.C., District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
    • Georgia
      • Macon, Georgia, United States, 31201
        • Atrium Health Navicent
      • Savannah, Georgia, United States, 31404
        • Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Permanente Moanalua Medical Center
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Rush-Copley Medical Center
      • Aurora, Illinois, United States, 60506
        • Advocate Outpatient Center - Aurora
      • Barrington, Illinois, United States, 60010
        • Advocate Good Shepherd Hospital
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare-Canton
      • Carthage, Illinois, United States, 62321
        • Illinois CancerCare-Carthage
      • Chicago, Illinois, United States, 60657
        • Advocate Illinois Masonic Medical Center
      • Crystal Lake, Illinois, United States, 60014
        • AMG Crystal Lake - Oncology
      • Danville, Illinois, United States, 61832
        • Carle at The Riverfront
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Downers Grove, Illinois, United States, 60515
        • Advocate Good Samaritan Hospital
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Effingham, Illinois, United States, 62401
        • Carle Physician Group-Effingham
      • Elgin, Illinois, United States, 60123
        • Advocate Sherman Hospital
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare-Eureka
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Hazel Crest, Illinois, United States, 60429
        • Advocate South Suburban Hospital
      • Kewanee, Illinois, United States, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Libertyville, Illinois, United States, 60048
        • Condell Memorial Hospital
      • Libertyville, Illinois, United States, 60048
        • AMG Libertyville - Oncology
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare-Macomb
      • Mattoon, Illinois, United States, 61938
        • Carle Physician Group-Mattoon/Charleston
      • O'Fallon, Illinois, United States, 62269
        • Cancer Care Center of O'Fallon
      • Oak Lawn, Illinois, United States, 60453-2699
        • Advocate Christ Medical Center
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Hospital
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare-Peru
      • Princeton, Illinois, United States, 61356
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic
      • Springfield, Illinois, United States, 62781
        • Springfield Memorial Hospital
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Washington, Illinois, United States, 61571
        • Illinois CancerCare - Washington
      • Yorkville, Illinois, United States, 60560
        • Rush-Copley Healthcare Center
    • Iowa
      • Ankeny, Iowa, United States, 50023
        • The University of Iowa - Ankeny
      • Carroll, Iowa, United States, 51401
        • Saint Anthony Regional Hospital
      • Cedar Rapids, Iowa, United States, 52403
        • Oncology Associates at Mercy Medical Center
      • Cedar Rapids, Iowa, United States, 52402
        • Physicians' Clinic of Iowa PC
      • Clive, Iowa, United States, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, United States, 50325
        • The University of Iowa - West De Moines
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50314
        • Broadlawns Medical Center
      • Des Moines, Iowa, United States, 50309
        • The University of Iowa - Des Moines
      • Des Moines, Iowa, United States, 50314
        • The University of Iowa - Laurel
      • Fort Dodge, Iowa, United States, 50501
        • Trinity Regional Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Saint Joseph Hospital East
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center New Orleans
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University Health Science Center
    • Maine
      • Augusta, Maine, United States, 04330
        • Harold Alfond Center for Cancer Care
      • Biddeford, Maine, United States, 04005
        • MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
      • Rockport, Maine, United States, 04856
        • Penobscot Bay Medical Center
      • Sanford, Maine, United States, 04073
        • MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
      • Scarborough, Maine, United States, 04074
        • Maine Medical Center- Scarborough Campus
      • South Portland, Maine, United States, 04106
        • Maine Medical Partners - South Portland
    • Maryland
      • Elkton, Maryland, United States, 21921
        • Christiana Care - Union Hospital
    • Michigan
      • Brighton, Michigan, United States, 48114
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
      • Canton, Michigan, United States, 48188
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
      • Chelsea, Michigan, United States, 48118
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
      • Flint, Michigan, United States, 48503
        • Genesee Cancer and Blood Disease Treatment Center
      • Flint, Michigan, United States, 48503
        • Genesee Hematology Oncology PC
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Livonia, Michigan, United States, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Pontiac, Michigan, United States, 48341
        • Trinity Health Saint Joseph Mercy Oakland Hospital
      • Saginaw, Michigan, United States, 48601
        • Ascension Saint Mary's Hospital
      • Wyoming, Michigan, United States, 49519
        • University of Michigan Health - West
      • Ypsilanti, Michigan, United States, 48197
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
    • Minnesota
      • Baxter, Minnesota, United States, 56425
        • Essentia Health - Baxter Clinic
      • Bemidji, Minnesota, United States, 56601
        • Sanford Joe Lueken Cancer Center
      • Brainerd, Minnesota, United States, 56401
        • Essentia Health Saint Joseph's Medical Center
      • Burnsville, Minnesota, United States, 55337
        • Minnesota Oncology - Burnsville
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Deer River, Minnesota, United States, 56636
        • Essentia Health - Deer River Clinic
      • Detroit Lakes, Minnesota, United States, 56501
        • Essentia Health Saint Mary's - Detroit Lakes Clinic
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Cancer Center
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Ely, Minnesota, United States, 55731
        • Essentia Health - Ely Clinic
      • Fosston, Minnesota, United States, 56542
        • Essentia Health - Fosston
      • Hibbing, Minnesota, United States, 55746
        • Essentia Health Hibbing Clinic
      • International Falls, Minnesota, United States, 56649
        • Essentia Health - International Falls Clinic
      • Maple Grove, Minnesota, United States, 55369
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Monticello, Minnesota, United States, 55362
        • Monticello Cancer Center
      • New Ulm, Minnesota, United States, 56073
        • New Ulm Medical Center
      • Park Rapids, Minnesota, United States, 56470
        • Essentia Health - Park Rapids
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Regional Medical Center
      • Virginia, Minnesota, United States, 55792
        • Essentia Health Virginia Clinic
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology PA-Woodbury
      • Wyoming, Minnesota, United States, 55092
        • Fairview Lakes Medical Center
    • Mississippi
      • Oxford, Mississippi, United States, 38655
        • Baptist Memorial Hospital and Cancer Center-Oxford
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Saint Louis Cancer and Breast Institute-Ballwin
      • Joplin, Missouri, United States, 64804
        • Mercy Hospital Joplin
      • Osage Beach, Missouri, United States, 65065
        • Lake Regional Hospital
      • Rolla, Missouri, United States, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, United States, 63128
        • Mercy Hospital South
    • Nebraska
      • Kearney, Nebraska, United States, 68847
        • CHI Health Good Samaritan
    • Nevada
      • Henderson, Nevada, United States, 89052
        • OptumCare Cancer Care at Seven Hills
      • Las Vegas, Nevada, United States, 89102
        • OptumCare Cancer Care at Charleston
      • Las Vegas, Nevada, United States, 89148
        • OptumCare Cancer Care at Fort Apache
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • CentraState Medical Center
      • Hackettstown, New Jersey, United States, 07840
        • Hackettstown Medical Center
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
      • Newton, New Jersey, United States, 07860
        • Newton Medical Center
      • Pennington, New Jersey, United States, 08534
        • Capital Health Medical Center-Hopewell
      • Pompton, New Jersey, United States, 07444
        • Chilton Medical Center
      • Summit, New Jersey, United States, 07901
        • Overlook Medical Center
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Hospital
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Randolph Health Cancer Center
      • Burlington, North Carolina, United States, 27215
        • Cone Health Cancer Center at Alamance Regional
      • Greensboro, North Carolina, United States, 27403
        • Cone Health Cancer Center
      • Greensboro, North Carolina, United States, 27410
        • Cone Health Cancer Center at Drawbridge Parkway
      • Reidsville, North Carolina, United States, 27320
        • Annie Penn Memorial Hospital
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, United States, 58103
        • Essentia Health Cancer Center-South University Clinic
      • Fargo, North Dakota, United States, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital - Cincinnati
      • Columbus, Ohio, United States, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, United States, 43213
        • Mount Carmel East Hospital
      • Gahanna, Ohio, United States, 43230
        • Central Ohio Breast and Endocrine Surgery
      • Grove City, Ohio, United States, 43123
        • Mount Carmel Grove City Hospital
      • Westerville, Ohio, United States, 43081
        • Saint Ann's Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Hospital Oklahoma City
    • Oregon
      • Bend, Oregon, United States, 97701
        • Saint Charles Health System
      • Newberg, Oregon, United States, 97132
        • Providence Newberg Medical Center
      • Oregon City, Oregon, United States, 97045
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Saint Vincent Medical Center
      • Redmond, Oregon, United States, 97756
        • Saint Charles Health System-Redmond
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Cancer Center
      • Beaufort, South Carolina, United States, 29902
        • Beaufort Memorial Hospital
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Gaffney, South Carolina, United States, 29341
        • Gibbs Cancer Center-Gaffney
      • Greenwood, South Carolina, United States, 29646
        • Self Regional Healthcare
      • Greer, South Carolina, United States, 29651
        • Gibbs Cancer Center-Pelham
      • Okatie, South Carolina, United States, 29909
        • Beaufort Memorial/New River Cancer Center
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Center
      • Union, South Carolina, United States, 29379
        • SMC Center for Hematology Oncology-Union
      • West Columbia, South Carolina, United States, 29169
        • Lexington Medical Center
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • Baptist Memorial Hospital and Cancer Center-Collierville
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital and Cancer Center-Memphis
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital for Women
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Chesapeake Regional Medical Center
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University/Massey Cancer Center
      • Winchester, Virginia, United States, 22601
        • Shenandoah Oncology PC
    • Washington
      • Bellevue, Washington, United States, 98004
        • Kaiser Permanente Bellevue Medical Center
      • Bellingham, Washington, United States, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Kennewick, Washington, United States, 99336
        • Kadlec Clinic Hematology and Oncology
      • Seattle, Washington, United States, 98112
        • Kaiser Permanente Washington
      • Sedro-Woolley, Washington, United States, 98284
        • PeaceHealth United General Medical Center
      • Walla Walla, Washington, United States, 99362
        • Providence Saint Mary Regional Cancer Center
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • ThedaCare Regional Cancer Center
      • Ashland, Wisconsin, United States, 54806
        • Duluth Clinic Ashland
      • Berlin, Wisconsin, United States, 54923
        • ThedaCare Cancer Care - Berlin
      • Burlington, Wisconsin, United States, 53105
        • Aurora Cancer Care-Southern Lakes VLCC
      • Chippewa Falls, Wisconsin, United States, 54729
        • Marshfield Clinic-Chippewa Center
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Germantown, Wisconsin, United States, 53022
        • Aurora Health Care Germantown Health Center
      • Grafton, Wisconsin, United States, 53024
        • Aurora Cancer Care-Grafton
      • Green Bay, Wisconsin, United States, 54311
        • Aurora BayCare Medical Center
      • Kenosha, Wisconsin, United States, 53142
        • Aurora Cancer Care-Kenosha South
      • Ladysmith, Wisconsin, United States, 54848
        • Marshfield Medical Center - Ladysmith
      • Marinette, Wisconsin, United States, 54143
        • Aurora Bay Area Medical Group-Marinette
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center-Marshfield
      • Milwaukee, Wisconsin, United States, 53209
        • Aurora Cancer Care-Milwaukee
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Saint Luke's Medical Center
      • Milwaukee, Wisconsin, United States, 53233
        • Aurora Sinai Medical Center
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Medical Center - Minocqua
      • Neenah, Wisconsin, United States, 54956
        • ThedaCare Regional Medical Center - Neenah
      • New London, Wisconsin, United States, 54961
        • ThedaCare Cancer Care - New London
      • New Richmond, Wisconsin, United States, 54017
        • Westfields Hospital/Cancer Center of Western Wisconsin
      • Oshkosh, Wisconsin, United States, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Oshkosh, Wisconsin, United States, 54904
        • ThedaCare Cancer Care - Oshkosh
      • Racine, Wisconsin, United States, 53406
        • Aurora Cancer Care-Racine
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Medical Center-Rice Lake
      • Shawano, Wisconsin, United States, 54166
        • ThedaCare Cancer Care - Shawano
      • Sheboygan, Wisconsin, United States, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Stevens Point, Wisconsin, United States, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Summit, Wisconsin, United States, 53066
        • Aurora Medical Center in Summit
      • Two Rivers, Wisconsin, United States, 54241
        • Vince Lombardi Cancer Clinic-Two Rivers
      • Waupaca, Wisconsin, United States, 54981
        • ThedaCare Cancer Care - Waupaca
      • Wausau, Wisconsin, United States, 54401
        • Marshfield Clinic-Wausau Center
      • Wauwatosa, Wisconsin, United States, 53226
        • Aurora Cancer Care-Milwaukee West
      • West Allis, Wisconsin, United States, 53227
        • Aurora West Allis Medical Center
      • Weston, Wisconsin, United States, 54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Marshfield Clinic - Wisconsin Rapids Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • History of Stage 0-III breast cancer diagnosis. History of non-breast malignancies are permitted.
  • ≥12 weeks following last primary cancer treatment. For this protocol, primary cancer treatments are defined as chemotherapy, cytotoxic antibody-drug conjugates, checkpoint inhibitors, radiation, and surgical procedures intended to remove malignant tissue. Ongoing adjuvant endocrine therapy (e.g., tamoxifen, aromatase inhibitors), adjuvant cdk 4/6-inhibitors (e.g., abemaciclib), HER2-based Monoclonal antibody therapy (e.g., trastuzumab, pertuzumab), HER2 targeted Tyrosine Kinase inhibitors (e.g., neratinib), and/or pending breast reconstructive surgery are allowed. (There is no upper limit on time since treatment.)
  • Age ≥ 18 years at the time of study enrollment

SELF-REPORTED ELIGIBILITY SCREENER INCLUSION

  • female
  • Currently in an intimate relationship, as reported on the Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction (PROMIS SexFS) screener (this relationship may be with an individual of any sex)
  • Endorse being at least "somewhat" bothered by >=1 of the following during the last 30 days: (lack of) interest in sexual activity, vaginal dryness, pain during sexual activity, or (in)ability to orgasm, as reported on the PROMIS SexFS Bother Regarding Sexual Function screener
  • Endorse that ≥ 1 of the bothersome sexual symptoms, from the PROMIS SexFS Bother Regarding Sexual Function screener is related to their breast cancer
  • Has a working email address (or willing to create one) and receive emails from the study

Exclusion Criteria:

  • Planned cancer treatment for residual, progressive, or recurrent disease within the 24 weeks following enrollment (defined as chemotherapy, cytotoxic antibody-drug conjugates, checkpoint inhibitors, radiation, and/or surgical procedures intended to remove malignant tissue). Ongoing adjuvant endocrine therapy (e.g., tamoxifen, aromatase inhibitors), adjuvant cdk 4/6-inhibitors (e.g., abemaciclib), HER2-based Monoclonal antibody therapy (e.g., trastuzumab, pertuzumab), HER2 targeted Tyrosine Kinase inhibitors (e.g., neratinib), and/or pending breast reconstructive surgery are allowed.
  • Unable to read and comprehend English (SHINE intervention currently only available in English) as indicated by being unable to complete the self-reported screening questionnaire independently

SELF-REPORTED ELIGIBILITY SCREENER EXCLUSION

  • Does not have reliable access to internet (e.g., by home broadband, public network, personal data plan) by computer, tablet, smartphone etc. and is not willing to participate in the tablet lending program for this study
  • Recent serious mental illness, as defined by reporting an inpatient psychiatric hospitalization within the past 12 months
  • Currently participating in couple, marital, or sex therapy
  • Currently pregnant (Pregnant women are excluded from this study because childbirth is accompanied by significant biological, psychological, and environmental changes that alter a woman's sexual functioning. Intervention content may not be medically appropriate for women who have recently given birth, given that medical providers commonly recommend that women avoid sexual contact for at least four to six weeks post-partum while healing.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHINE 1

SHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - 45 minutes, 4) Intimacy - 45 minutes Each component is a single lesson accessed at participant's convenience and may be repeated.

Psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Enhanced version is tailored, interactive instruction and recommendations for over-the-counter products and aids.

Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician.

Communication with partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner.

Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
Other: Internet-based Intervention
Receive access to SHINE modules
Experimental: SHINE 2

SHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - 45 minutes, 4) Intimacy - NONE.

Each component is a single lesson accessed at participant's convenience and may be repeated.

Psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Enhanced version is tailored, interactive instruction and recommendations for over-the-counter products and aids.

Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician.

Communication with partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner.
Other: Internet-based Intervention
Receive access to SHINE modules
Experimental: SHINE 3

SHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - NONE, 4) Intimacy - 45 minutes.

Each component is a single lesson accessed at participant's convenience and may be repeated.

Psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Enhanced version is tailored, interactive instruction and recommendations for over-the-counter products and aids.

Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician.

Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
Other: Internet-based Intervention
Receive access to SHINE modules
Experimental: SHINE 4

SHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - NONE, 4) Intimacy - NONE.

Each component is a single lesson accessed at participant's convenience and may be repeated.

Psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Enhanced version is tailored, interactive instruction and recommendations for over-the-counter products and aids.

Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician.
Other: Internet-based Intervention
Receive access to SHINE modules
Experimental: SHINE 5

SHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - 45 minutes, 4) Intimacy - 45 minutes.

Each component is a single lesson accessed at participant's convenience and may be repeated.

Psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Enhanced version is tailored, interactive instruction and recommendations for over-the-counter products and aids.

Communication with partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner.

Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
Other: Internet-based Intervention
Receive access to SHINE modules
Experimental: SHINE 6

SHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - 45 minutes, 4) Intimacy - NONE.

Each component is a single lesson accessed at participant's convenience and may be repeated.

Psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Enhanced version is tailored, interactive instruction and recommendations for over-the-counter products and aids.

Communication with partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner.
Other: Internet-based Intervention
Receive access to SHINE modules
Experimental: SHINE 7

SHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - NONE, 4) Intimacy - 45 minutes.

Each component is a single lesson accessed at participant's convenience and may be repeated.

Psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Enhanced version is tailored, interactive instruction and recommendations for over-the-counter products and aids.

Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
Other: Internet-based Intervention
Receive access to SHINE modules
Experimental: SHINE 8

SHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - NONE, 4) Intimacy - NONE.

Each component is a single lesson accessed at participant's convenience and may be repeated.

Psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Enhanced version is tailored, interactive instruction and recommendations for over-the-counter products and aids.
Other: Internet-based Intervention
Receive access to SHINE modules
Experimental: SHINE 9

SHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - 45 minutes, 4) Intimacy - 45 minutes.

Each component is a single lesson accessed at participant's convenience and may be repeated.

Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy.

Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician.

Communication with partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner.

Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
Other: Internet-based Intervention
Receive access to SHINE modules
Experimental: SHINE 10

SHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - 45 minutes, 4) Intimacy - NONE.

Each component is a single lesson accessed at participant's convenience and may be repeated.

Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy.

Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician.

Communication with partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner.
Other: Internet-based Intervention
Receive access to SHINE modules
Experimental: SHINE 11

SHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - NONE, 4) Intimacy - 45 minutes.

Each component is a single lesson accessed at participant's convenience and may be repeated.

Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy.

Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician.

Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
Other: Internet-based Intervention
Receive access to SHINE modules
Experimental: SHINE 12

SHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - NONE, 4) Intimacy -NONE.

Each component is a single lesson accessed at participant's convenience and may be repeated.

Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy.

Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician.
Other: Internet-based Intervention
Receive access to SHINE modules
Experimental: SHINE 13

SHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - 45 minutes, 4) Intimacy - 45 minutes.

Each component is a single lesson accessed at participant's convenience and may be repeated.

Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy.

Communication with partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner.

Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
Other: Internet-based Intervention
Receive access to SHINE modules
Experimental: SHINE 14

SHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - 45 minutes, 4) Intimacy - NONE.

Each component is a single lesson accessed at participant's convenience and may be repeated.

Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy.

Communication with partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner.
Other: Internet-based Intervention
Receive access to SHINE modules
Experimental: SHINE 15

SHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - NONE, 4) Intimacy - 45 minutes.

Each component is a single lesson accessed at participant's convenience and may be repeated.

Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy.

Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
Other: Internet-based Intervention
Receive access to SHINE modules
Experimental: SHINE 16

SHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - NONE, 4) Intimacy - NONE.

Each component is a single lesson accessed at participant's convenience and may be repeated.

Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy.
Other: Internet-based Intervention
Receive access to SHINE modules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sexual distress as measured by the total sum score of the Female Sexual Distress Scale - Desire, Arousal, Orgasm (FSDS-DAO). The total sum score ranges from 0-60 with higher scores reflecting greater distress.
Time Frame: From baseline to 24 weeks
Estimated mean change from Baseline to 24 weeks with main effect of Time will be obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants will be utilized in the model (ITT analysis).
From baseline to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)
University of Virginia

Investigators

  • Study Chair: Glenn Lesser, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00104518
  • NCI-2023-06866 (Registry Identifier: NCI CTRP)
  • WF-2202 (Other Identifier: Wake Forest NCORP Research Base)
  • R37CA269776 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.

IPD Sharing Time Frame

Data will be submitted to the archive 6 months post-publication and maintained according to data archive guidelines.

IPD Sharing Access Criteria

upon request to NCORP@wakehealth.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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