An Internet-based Program to Help Cancer Survivors Manage Pain (IMPACTS)

August 9, 2026 updated by: Wake Forest University Health Sciences

Internet-delivered Management of Pain Among Cancer Treatment Survivors

To determine whether an Internet-based pain coping skills program plus enhanced usual care, compared to enhanced usual care alone, yields significant improvements in the co-primary outcomes of pain severity (as measured by the Brief Pain Inventory (BPI)) and pain interference (also measured by the BPI) from baseline to the post-intervention assessment for cancer survivors with persistent pain.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a parallel group randomized controlled, prospective study that examines the effect of an Internet-based pain coping skills program on pain severity and pain interference among adult cancer survivors experiencing persistent cancer-related pain. The study also explores the effects of an Internet-based pain coping skills program on opioid/analgesic medication use, health-related quality of life, pain management self-efficacy and various other factors relevant among populations with persistent pain (i.e., fatigue, sleep, emotional distress, positive affect, pain impact, perceived cognitive problems, and cognitive performance), as well as qualitative assessments of participants experiences with pain and the intervention. A total of 250 participants will be enrolled (125 per arm) and randomized into the internet program arm (plus enhanced usual care) or Enhanced Usual Care alone.

Each participant will be enrolled in the study for 9 months (from randomization at week 0 to the final follow-up assessment at week 34).

Study Type

Interventional

Enrollment (Estimated)

456

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

  • Guam
    • GU
      • Tamuning, GU, Guam, 96913
        • FHP Health Center-Guam
  • United States
    • 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
      • 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
    • Colorado
      • Denver, Colorado, United States, 80205
        • Kaiser Permanente-Franklin
      • Lafayette, Colorado, United States, 80026
        • Kaiser Permanente-Rock Creek
      • Lone Tree, Colorado, United States, 80124
        • Kaiser Permanente-Lone Tree
    • Georgia
      • Columbus, Georgia, United States, 31904
        • John B. Amos Cancer Center
      • Savannah, Georgia, United States, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, United States, 96817
        • The Cancer Center of Hawaii-Liliha
      • Honolulu, Hawaii, United States, 96813
        • Hawaii Cancer Care Inc - Waterfront Plaza
      • Honolulu, Hawaii, United States, 96813
        • Queen's Cancer Cenrer - POB I
      • Honolulu, Hawaii, United States, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, United States, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, United States, 96817
        • Queen's Cancer Center - Kuakini
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Permanente Moanalua Medical Center
      • Honolulu, Hawaii, United States, 96859
        • Tripler Army Medical Center
      • ‘Aiea, Hawaii, United States, 96701
        • Hawaii Cancer Care - Westridge
      • ‘Aiea, Hawaii, United States, 96701
        • Pali Momi Medical Center
      • ‘Aiea, Hawaii, United States, 96701
        • The Cancer Center of Hawaii-Pali Momi
      • ‘Aiea, Hawaii, United States, 96701
        • Hawaii Cancer Care - Savio
      • ‘Ewa Beach, Hawaii, United States, 96706
        • The Queen's Medical Center - West Oahu
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare-Bloomington
      • Bloomington, Illinois, United States, 61704
        • Carle BroMenn Outpatient Center
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare-Canton
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Danville, Illinois, United States, 61832
        • Carle on Vermilion
      • 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
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Mattoon, Illinois, United States, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Normal, Illinois, United States, 61761
        • Carle Cancer Institute Normal
      • Normal, Illinois, United States, 61761
        • Carle BroMenn Medical Center
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare-Peru
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Washington, Illinois, United States, 61571
        • Illinois CancerCare - Washington
    • Iowa
      • Ankeny, Iowa, United States, 50023
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
      • Cedar Rapids, Iowa, United States, 52402
        • Physicians' Clinic of Iowa PC
      • Clive, Iowa, United States, 50325
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50309
        • Medical Oncology and Hematology Associates-Des Moines
      • Des Moines, Iowa, United States, 50314
        • Broadlawns Medical Center
      • Des Moines, Iowa, United States, 50314
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
      • Waukee, Iowa, United States, 50263
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Flaget Memorial Hospital
      • Lexington, Kentucky, United States, 40504
        • Saint Joseph Radiation Oncology Resource Center
      • Lexington, Kentucky, United States, 40509
        • Saint Joseph Hospital East
      • London, Kentucky, United States, 40741
        • Saint Joseph London
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center Jefferson
      • New Orleans, Louisiana, United States, 70115
        • Ochsner Baptist Medical Center
      • Shreveport, Louisiana, United States, 71105
        • CHRISTUS Highland Medical Center
    • Maine
      • Sanford, Maine, United States, 04073
        • MaineHealth Cancer Care Center of York County
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Brighton, Michigan, United States, 48114
        • Trinity Health Medical Center - Brighton
      • Canton, Michigan, United States, 48118
        • Trinity Health Medical Center - Canton
      • Chelsea, Michigan, United States, 48118
        • 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
      • Iron Mountain, Michigan, United States, 49801
        • Marshfield Medical Center Dickinson
      • Livonia, Michigan, United States, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Pontiac, Michigan, United States, 48341
        • Trinity Health Saint Joseph Mercy Oakland Hospital
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • 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
      • Stillwater, Minnesota, United States, 55082
        • Lakeview Hospital
      • Willmar, Minnesota, United States, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology PA-Woodbury
    • Missouri
      • Bolivar, Missouri, United States, 65613
        • Central Care Cancer Center - Bolivar
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
    • 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
      • New Brunswick, New Jersey, United States, 08901
        • Saint Peter's University Hospital
      • Newton, New Jersey, United States, 07860
        • Newton Medical Center
      • Pompton, New Jersey, United States, 07444
        • Chilton Medical Center
      • Summit, New Jersey, United States, 07901
        • Overlook Medical Center
    • North Carolina
      • Clemmons, North Carolina, United States, 27012
        • Wake Forest University at Clemmons
      • Lexington, North Carolina, United States, 27292
        • Wake Forest University at Lexington
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Columbus, Ohio, United States, 43219
        • The Mark H Zangmeister Center
      • Marysville, Ohio, United States, 43040
        • Memorial Hospital
      • Mount Vernon, Ohio, United States, 43050
        • Knox Community Hospital
      • Portsmouth, Ohio, United States, 45662
        • Southern Ohio Medical Center
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Hazleton, Pennsylvania, United States, 18201
        • Geisinger Medical Center-Cancer Center Hazleton
      • Lewisburg, Pennsylvania, United States, 17837
        • Geisinger Medical Oncology-Lewisburg
      • Pottsville, Pennsylvania, United States, 17901
        • Geisinger Cancer Services-Pottsville
      • Scranton, Pennsylvania, United States, 18510
        • Community Medical Center
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
    • South Carolina
      • Bluffton, South Carolina, United States, 29910
        • Saint Joseph's/Candler - Bluffton Campus
      • Boiling Springs, South Carolina, United States, 29316
        • Prisma Health Cancer Institute - Spartanburg
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Easley, South Carolina, United States, 29640
        • Prisma Health Cancer Institute - Easley
      • Georgetown, South Carolina, United States, 29440
        • Tidelands Georgetown Memorial Hospital
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, United States, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Cancer Institute - Butternut
      • Greenwood, South Carolina, United States, 29646
        • Self Regional Healthcare
      • Greer, South Carolina, United States, 29650
        • Prisma Health Cancer Institute - Greer
      • Hilton Head Island, South Carolina, United States, 29926
        • South Carolina Cancer Specialists PC
      • Seneca, South Carolina, United States, 29672
        • Prisma Health Cancer Institute - Seneca
    • Virginia
      • Gloucester, Virginia, United States, 23061
        • Peninsula Cancer Institute - Gloucester
      • Newport News, Virginia, United States, 23601
        • Peninsula Cancer Institute - Newport News
      • Richmond, Virginia, United States, 23235
        • VCU Massey Cancer Center at Stony Point
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University/Massey Cancer Center
      • South Hill, Virginia, United States, 23970
        • VCU Community Memorial Health Center
      • Virginia Beach, Virginia, United States, 23235
        • Peninsula Cancer Institute - Cancer Specialists of Tidewater
      • Williamsburg, Virginia, United States, 23185
        • Peninsula Cancer Institute - Williamsburg
    • Wisconsin
      • Chippewa Falls, Wisconsin, United States, 54729
        • Marshfield Clinic-Chippewa Center
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Ladysmith, Wisconsin, United States, 54848
        • Marshfield Medical Center - Ladysmith
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center-Marshfield
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Medical Center - Minocqua
      • Neillsville, Wisconsin, United States, 54456
        • Marshfield Medical Center - Neillsville
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Medical Center-Rice Lake
      • Stevens Point, Wisconsin, United States, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Wausau, Wisconsin, United States, 54401
        • Marshfield Clinic-Wausau 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Must have a documented diagnosis of invasive cancer that has been treated with either single modality therapy or any combination of surgery, radiation, and chemotherapy/drug therapy (e.g. cytotoxic therapy, targeted therapy, immunotherapy, hormonal therapy, etc.). Patients with a cancer history of only superficial skin cancers or in situ malignancy are not eligible.

  • May be either off all treatment OR actively receiving anticancer therapy in an adjuvant setting, maintenance setting, or for active cancer.

    • Patients who currently undergoing anticancer therapy should not have any plans to change or adjust their treatment during the intervention period. This includes changing to another therapy or ending therapy entirely.
    • Patients who are currently receiving anticancer therapy at the screening process must have been on current therapy for at least four weeks. Alternatively, if they are planning to discontinue therapy before enrolling, they must have been off therapy for four weeks prior to enrollment.
    • A minimum of four weeks must have elapsed since the most recent MAJOR surgical intervention.
    • A minimum of two weeks must have elapsed since the most recent MINOR surgical procedure (e.g., port placement).
    • In addition, eligible patients must not have a planned surgical procedure or course of radiation therapy during the 3-month study intervention period (i.e., the three months leading up to primary outcome evaluation-timepoint.
  • Patients who are no longer receiving anticancer therapy must be less than/equal to 5 years since the completion of their anticancer therapy (e.g., time since the last day of chemotherapy administration, time since last day of radiotherapy, etc.).
  • Must have pain indicated by a score of ≥ 4 on PROMIS Pain Intensity (1a) scale, using the Pain Eligibility Interview.
  • Must have a score of "Most Days" or higher on the Graded Chronic Pain Scale Revised (Abbreviated) using the Pain Eligibility Interview.
  • Patients do not have to be on analgesic medications of any kind in order to participate. If they are taking analgesics, they must be on a stable analgesic regimen (i.e., no changes to the prescribed analgesic regimen) over a period of at least 14 days prior to enrollment. Eligible patients should not have planned upward dose titration of their analgesics during the 3-month study intervention period (i.e., the three months leading up to primary outcome evaluation timepoint. Patients may elect to decrease their analgesic use during the study as per discussions with their provider. Unexpected dose adjustments including dose escalations as a result of unforeseen clinical need is allowed in all patients at all times during the study. Cannabis prescribed for medicinal purposes would qualify as an analgesic in this context.
  • Must have pain of new onset or significantly exacerbated since the time of cancer diagnosis or initiation of cancer treatment
  • Must be expected to be able to complete all study activities including the 22- and 34-week follow-up assessments according to the treating/referring clinician (e.g., treating clinician feels the patient is unlikely to develop progressive disease requiring additional active cancer therapy through the 6-month follow-up period).
  • ECOG performance status of 0, 1, or 2.
  • Age ≥18 years at the time of study entry
  • Must be able to speak, read and understand English.

Exclusion Criteria:

  • Has a disability that precludes completion of study activities (e.g., severe vision or hearing impairment, diagnosis of dementia or clinical evidence of severe cognitive impairment, diagnosis or clinical evidence of severe psychiatric disorder, or diagnosed drug or alcohol abuse disorder), as per patient report or documented in the medical record.
  • Reports only preexisting pain conditions unrelated to cancer or cancer treatment (e.g., migraine or tension headache, arthritis, back disorders, bursitis/tendonitis, injuries, fibromyalgia).
  • Has a known or suspected diagnosable substance use disorder or opioid overuse disorder (according to DSM-5 criteria), or is actively receiving treatment for a substance use disorder, as per patient report or documented in the medical record.
  • Currently being prescribed buprenorphine or suboxone.
  • Patients enrolled on hospice care or end-of-life palliative care are not eligible for enrollment. Patients whose local care network provides an opportunity for palliative (symptom management) or supportive care concurrent with active treatment following diagnosis (i.e. not solely as a palliative or end-of-life measure) are considered eligible for this study.
  • Does not have reliable access to Internet or sufficient personal data plan, and is not willing to participate in the Tablet Lending Program provided for this study.
  • Does not have a working email address.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet-based program + Pain Education
If you are in this group, in additional to your usual care, you will be provided access to the 8-session Internet-based pain program plus pain education. You will need to complete your sessions within 10 weeks of being provided your log-in code. You will be allowed to revisit sessions that you have completed during this 10 weeks. After completion of the study, you will still be provided access to the 8-session Internet-based pain program.
Behavioral: Internet-based pain coping skills program
The purpose of this study is to determine if an 8-session Internet-based pain management program can help you better manage your cancer-related pain.
No Intervention: Pain Education Only
If you are in this group, in addition to your usual care, you will be provided pain education at your initial clinic visit. After you have completed the 6-month follow up assessment, you will be provided a secure log-in code and invited to complete the 8 sessions of this Internet-based pain program on your own.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Severity
Time Frame: Change from Baseline to 10 week
The Pain Severity via Brief Pain Inventory (BPI) subscale score is the mean of 4 items measuring current pain, pain on average, and pain at its worst and least in the past 7 days on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Change from Baseline to 10 week
Pain Interference
Time Frame: Change from Baseline to 10 week
The Pain Interference via Brief Pain Inventory (BPI) subscale score is the mean rating of 7 items measuring impact of pain on walking, work, mood, enjoyment of life, relations with others, sleep, general activity on a scale from 0 (does not interfere) to 10 (completely interferes).
Change from Baseline to 10 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Severity
Time Frame: 22 and 34 weeks
The Pain Severity via Brief Pain Inventory (BPI) subscale score is the mean of 4 items measuring current pain, pain on average, and pain at its worst and least in the past 7 days on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).
22 and 34 weeks
Pain Interference
Time Frame: 22 and 34 weeks
The Pain Interference via Brief Pain Inventory (BPI) subscale score is the mean rating of 7 items measuring impact of pain on walking, work, mood, enjoyment of life, relations with others, sleep, general activity on a scale from 0 (does not interfere) to 10 (completely interferes).
22 and 34 weeks
Opioid/analgesic medication use
Time Frame: Baseline and 10 week
A participant recall during clinic visits of typical daily medication use. This will be converted to morphine milligram equivalents (MME).
Baseline and 10 week
Opioid/analgesic medication use
Time Frame: Baseline, 10, 22, and 24 week
7-day medication diaries to capture participants' use of all medications each day during a 7-day period. Self-reports will be converted to morphine milligram equivalents (MME).
Baseline, 10, 22, and 24 week
Health-Related Quality of Life
Time Frame: Baseline, 10, 22, and 24 week
Health-Related Quality of Life will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form-6b). The six items are summed to give a score from 6 to 30, with higher scores representing better physical function.
Baseline, 10, 22, and 24 week
Pain Management Self-Efficacy
Time Frame: Baseline, 10, 22, and 24 week
Pain Management Self-Efficacy will be assessed with the Chronic Pain Self-Efficacy Scale. The self-efficacy for pain management subscale (PSE) consists of five items summed to give a score from 50-500, the self-efficacy for physical function subscale (FSE) consists of nine items summed to give a score from 90-900, and the self-efficacy for coping with symptoms subscale (CSE) consists of eight items summed to give a score from 80-800. For all subscales, higher scores represent greater self-efficacy.
Baseline, 10, 22, and 24 week

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)
National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

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

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)

May 13, 2021

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

July 2, 2020

First Submitted That Met QC Criteria

July 2, 2020

First Posted (Actual)

July 8, 2020

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 9, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00066906
  • 3UG1CA189824-06S1 (U.S. NIH Grant/Contract)
  • WF-1901 (Other Identifier: Wake Forest NCORP Research Base)
  • NCI-2020-02315 (Registry Identifier: NCI CTRP (Clinical Trial Reporting Program))

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

6 months after publication for a 2 year duration

IPD Sharing Access Criteria

upon request to NCORP@wakehealth.edu

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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