Testing Diet Intervention Versus Non-Diet Intervention for Management of Bowel Symptoms in Rectal Cancer Survivors

April 3, 2024 updated by: SWOG Cancer Research Network

A Randomized Trial of the Altering Intake, Managing Symptoms Intervention for Bowel Dysfunction in Rectal Cancer Survivors Compared to a Healthy Living Education Control: A Feasibility and Preliminary Efficacy Study (AIMS-RC)

This phase II trial studies how a diet intervention works in improving bowel dysfunction symptoms related in colon or rectal cancer survivors. Changing a diet may be helpful in reducing the severity of bowel symptoms, including diarrhea and constipation, and improve quality of life in colon or rectal cancer survivors and help doctors learn how to help patients better in the future.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To compare total bowel function score, as measured by the Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (BFI), at 18 weeks post-randomization between the intervention and attention control arms.

EXPLORATORY OBJECTIVES:

I. To compare total bowel function score at 26 weeks post-randomization between the intervention and attention control arms.

II. To compare bowel function subscale scores (dietary, urgency, frequency), as measured by the BFI at both 18- and 26- weeks post-randomization between the intervention and attention control arms.

III. To compare lower anterior resection syndrome (LARS) scores (for anastomosis participants only), quality of life, and dietary quality at both 18- and 26- weeks post-randomization between the intervention and attention control arms.

IV. To compare motivation, self-efficacy, and positive/negative affect at both 18- and 26- weeks post-randomization between the intervention and attention control arms.

V. To assess study feasibility, adherence, retention, and acceptability at both 18 and 26 weeks post-randomization.

VI. To explore variation in primary and exploratory study outcomes according to sex, and to investigate whether intervention effects on the primary outcome differ across subgroups defined by sex.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive diet modification coaching via telephone for 10 sessions over 30-60 minutes over 17 weeks. Patients also receive 3 motivational messages per week via email and/or text message beginning after session 6.

ARM II: Patients receive general healthy living education via telephone for 10 sessions over 30-60 minutes over 17 weeks. Patients also receive 3 motivational messages per week via email and/or text message beginning after session 6.

After completion of study, patients are followed up at 26 weeks.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 2

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
      • Tamuning, Guam, 96913
        • FHP Health Center-Guam
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Banner University Medical Center - Tucson
      • Tucson, Arizona, United States, 85719
        • University of Arizona Cancer Center-North Campus
    • California
      • Costa Mesa, California, United States, 92627
        • UC Irvine Health Cancer Center-Newport
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center
      • Orange, California, United States, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Whittier, California, United States, 90602
        • Presbyterian Intercommunity Hospital
    • 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
    • Florida
      • Atlantis, Florida, United States, 33462
        • John Fitzgerald Kennedy Medical Center
      • Aventura, Florida, United States, 33180
        • Mount Sinai Comprehensive Cancer Center at Aventura
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Hawaii Cancer Care - Savio
      • 'Aiea, Hawaii, United States, 96701
        • Pali Momi Medical Center
      • 'Aiea, Hawaii, United States, 96701
        • Queen's Cancer Center - Pearlridge
      • 'Aiea, Hawaii, United States, 96701
        • The Cancer Center of Hawaii-Pali Momi
      • 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
        • Hawaii Cancer Care Inc-Liliha
      • Honolulu, Hawaii, United States, 96817
        • Queen's Cancer Center - Kuakini
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children
      • Lihue, Hawaii, United States, 96766
        • Wilcox Memorial Hospital and Kauai Medical Clinic
    • Idaho
      • Lewiston, Idaho, United States, 83501
        • Saint Joseph Regional Medical Center
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Rush - Copley Medical Center
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare-Canton
      • Carthage, Illinois, United States, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, United States, 62801
        • Centralia Oncology Clinic
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Danville, Illinois, United States, 61832
        • Carle on Vermilion
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Dixon, Illinois, United States, 61021
        • Illinois CancerCare-Dixon
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Effingham, Illinois, United States, 62401
        • Carle Physician Group-Effingham
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare-Eureka
      • Galesburg, Illinois, United States, 61401
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Kewanee, Illinois, United States, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare-Macomb
      • Mattoon, Illinois, United States, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, United States, 61636
        • Methodist Medical Center of Illinois
      • 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, 62781
        • Memorial Medical Center
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Urbana, Illinois, United States, 61801
        • The Carle Foundation Hospital
      • Yorkville, Illinois, United States, 60560
        • Rush-Copley Healthcare Center
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic PC - Ames
      • Ames, Iowa, United States, 50010
        • Mary Greeley Medical Center
      • Boone, Iowa, United States, 50036
        • McFarland Clinic PC-Boone
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • 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, 50316
        • Iowa Lutheran Hospital
      • Fort Dodge, Iowa, United States, 50501
        • McFarland Clinic PC-Trinity Cancer Center
      • Jefferson, Iowa, United States, 50129
        • McFarland Clinic PC-Jefferson
      • Marshalltown, Iowa, United States, 50158
        • McFarland Clinic PC-Marshalltown
      • West Des Moines, Iowa, United States, 50266-7700
        • Methodist West Hospital
    • Kansas
      • Hays, Kansas, United States, 67601
        • HaysMed University of Kansas Health System
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center
      • Kansas City, Kansas, United States, 66112
        • University of Kansas Cancer Center-West
      • Lawrence, Kansas, United States, 66044
        • Lawrence Memorial Hospital
      • Olathe, Kansas, United States, 66061
        • Olathe Health Cancer Center
      • Overland Park, Kansas, United States, 66210
        • University of Kansas Cancer Center-Overland Park
      • Overland Park, Kansas, United States, 66211
        • University of Kansas Hospital-Indian Creek Campus
      • Westwood, Kansas, United States, 66205
        • University of Kansas Hospital-Westwood Cancer Center
    • Maine
      • Brewer, Maine, United States, 04412
        • Lafayette Family Cancer Center-EMMC
      • Portland, Maine, United States, 04102
        • Maine Medical Partners Surgical Care
      • Portland, Maine, United States, 04102
        • MMP Surgical Care Casco Bay
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Saint Joseph Mercy Hospital
      • Bay City, Michigan, United States, 48706
        • McLaren Cancer Institute-Bay City
      • Brighton, Michigan, United States, 48114
        • Saint Joseph Mercy Brighton
      • Brighton, Michigan, United States, 48114
        • IHA Hematology Oncology Consultants-Brighton
      • Canton, Michigan, United States, 48188
        • Saint Joseph Mercy Canton
      • Canton, Michigan, United States, 48188
        • IHA Hematology Oncology Consultants-Canton
      • Chelsea, Michigan, United States, 48118
        • Saint Joseph Mercy Chelsea
      • Chelsea, Michigan, United States, 48118
        • IHA Hematology Oncology Consultants-Chelsea
      • Clarkston, Michigan, United States, 48346
        • McLaren Cancer Institute-Clarkston
      • Dearborn, Michigan, United States, 48124
        • Beaumont Hospital - Dearborn
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48236
        • Ascension Saint John Hospital
      • East China Township, Michigan, United States, 48054
        • Great Lakes Cancer Management Specialists-Doctors Park
      • Farmington Hills, Michigan, United States, 48334
        • Weisberg Cancer Treatment Center
      • Farmington Hills, Michigan, United States, 48336
        • Beaumont Hospital - Farmington Hills
      • Flint, Michigan, United States, 48532
        • McLaren Cancer Institute-Flint
      • Flint, Michigan, United States, 48532
        • Singh and Arora Hematology Oncology PC
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Academic Hematology Oncology Specialists
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Michigan Breast Specialists-Grosse Pointe Woods
      • Lansing, Michigan, United States, 48910
        • McLaren-Greater Lansing
      • Lansing, Michigan, United States, 48912
        • Mid-Michigan Physicians-Lansing
      • Lapeer, Michigan, United States, 48446
        • McLaren Cancer Institute-Lapeer Region
      • Livonia, Michigan, United States, 48154
        • Saint Mary Mercy Hospital
      • Livonia, Michigan, United States, 48154
        • Hope Cancer Clinic
      • Macomb, Michigan, United States, 48044
        • Great Lakes Cancer Management Specialists-Macomb Medical Campus
      • Midland, Michigan, United States, 48670
        • Mid-Michigan Medical Center - Midland
      • Mount Pleasant, Michigan, United States, 48858
        • McLaren Cancer Institute-Central Michigan
      • Petoskey, Michigan, United States, 49770
        • McLaren Cancer Institute-Northern Michigan
      • Port Huron, Michigan, United States, 48060
        • McLaren-Port Huron
      • Rochester Hills, Michigan, United States, 48309
        • Great Lakes Cancer Management Specialists-Rochester Hills
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital-Royal Oak
      • Troy, Michigan, United States, 48085
        • William Beaumont Hospital - Troy
      • Warren, Michigan, United States, 48093
        • Saint John Macomb-Oakland Hospital
      • Warren, Michigan, United States, 48093
        • Great Lakes Cancer Management Specialists-Macomb Professional Building
      • Ypsilanti, Michigan, United States, 48106
        • Huron Gastroenterology PC
      • Ypsilanti, Michigan, United States, 48197
        • IHA Hematology Oncology Consultants-Ann Arbor
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Cambridge, Minnesota, United States, 55008
        • Cambridge Medical Center
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Unity Hospital
      • 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
      • Minneapolis, Minnesota, United States, 55454
        • Health Partners Inc
      • New Ulm, Minnesota, United States, 56073
        • New Ulm Medical Center
      • 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
      • Stillwater, Minnesota, United States, 55082
        • Lakeview Hospital
      • 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
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • Farmington, Missouri, United States, 63640
        • Parkland Health Center - Farmington
      • Kansas City, Missouri, United States, 64154
        • University of Kansas Cancer Center - North
      • Kansas City, Missouri, United States, 64108
        • Truman Medical Centers
      • Lee's Summit, Missouri, United States, 64064
        • University of Kansas Cancer Center - Lee's Summit
      • North Kansas City, Missouri, United States, 64116
        • University of Kansas Cancer Center at North Kansas City Hospital
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • Sainte Genevieve, Missouri, United States, 63670
        • Sainte Genevieve County Memorial Hospital
      • Sullivan, Missouri, United States, 63080
        • Missouri Baptist Sullivan Hospital
      • Sunset Hills, Missouri, United States, 63127
        • Missouri Baptist Outpatient Center-Sunset Hills
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson, Nevada, United States, 89052
        • OptumCare Cancer Care at Seven Hills
      • Henderson, Nevada, United States, 89074
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
      • Henderson, Nevada, United States, 89074
        • Las Vegas Urology - Green Valley
      • Henderson, Nevada, United States, 89074
        • Las Vegas Urology - Pebble
      • Henderson, Nevada, United States, 89074
        • Urology Specialists of Nevada - Green Valley
      • Las Vegas, Nevada, United States, 89102
        • OptumCare Cancer Care at Charleston
      • Las Vegas, Nevada, United States, 89106
        • Radiation Oncology Centers of Nevada Central
      • Las Vegas, Nevada, United States, 89128
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas, Nevada, United States, 89128
        • OptumCare Cancer Care at MountainView
      • Las Vegas, Nevada, United States, 89144
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas, Nevada, United States, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89148
        • OptumCare Cancer Care at Fort Apache
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, United States, 89074
        • Las Vegas Urology - Pecos
      • Las Vegas, Nevada, United States, 89103
        • Hope Cancer Care of Nevada
      • Las Vegas, Nevada, United States, 89106
        • Urology Specialists of Nevada - Central
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas Urology - Sunset
      • Las Vegas, Nevada, United States, 89128
        • Las Vegas Urology - Cathedral Rock
      • Las Vegas, Nevada, United States, 89128
        • Las Vegas Urology - Smoke Ranch
      • Las Vegas, Nevada, United States, 89128
        • Urology Specialists of Nevada - Northwest
      • Las Vegas, Nevada, United States, 89113
        • Urology Specialists of Nevada - Southwest
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • University of New Mexico Cancer Center
      • Albuquerque, New Mexico, United States, 87102
        • Lovelace Medical Center-Saint Joseph Square
    • Ohio
      • Belpre, Ohio, United States, 45714
        • Strecker Cancer Center-Belpre
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Cancer Center-UC Medical Center
      • Columbus, Ohio, United States, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, United States, 43214
        • Columbus Oncology and Hematology Associates Inc
      • Columbus, Ohio, United States, 43213
        • Mount Carmel East Hospital
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health Center West
      • Grove City, Ohio, United States, 43123
        • Mount Carmel Grove City Hospital
      • Marietta, Ohio, United States, 45750
        • Marietta Memorial Hospital
      • West Chester, Ohio, United States, 45069
        • University of Cincinnati Cancer Center-West Chester
      • Westerville, Ohio, United States, 43081
        • Saint Ann's Hospital
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Cancer Centers of Southwest Oklahoma Research
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Willow Grove, Pennsylvania, United States, 19090
        • Asplundh Cancer Pavilion
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Cancer Center
      • Boiling Springs, South Carolina, United States, 29316
        • Prisma Health Cancer Institute - Spartanburg
      • 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
      • Greer, South Carolina, United States, 29650
        • Prisma Health Cancer Institute - Greer
      • Seneca, South Carolina, United States, 29672
        • Prisma Health Cancer Institute - Seneca
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
    • Virginia
      • Richmond, Virginia, United States, 23235
        • VCU Massey Cancer Center at Stony Point
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University/Massey Cancer Center
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute
      • South Hill, Virginia, United States, 23970
        • VCU Community Memorial Health Center
      • Winchester, Virginia, United States, 22601
        • Shenandoah Oncology PC
      • Winchester, Virginia, United States, 22601
        • Valley Health / Winchester Medical Center
    • Washington
      • Mount Vernon, Washington, United States, 98274
        • Skagit Valley Hospital Regional Cancer Care Center
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center - Montlake
      • Sequim, Washington, United States, 98384
        • Olympic Medical Cancer Care Center
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Hospital and Clinics
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Langlade Hospital and Cancer Center
      • 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 Clinic - Ladysmith Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center-Marshfield
      • Medford, Wisconsin, United States, 54451
        • Aspirus Medford Hospital
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Clinic-Minocqua Center
      • New Richmond, Wisconsin, United States, 54017
        • Cancer Center of Western Wisconsin
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Medical Center-Rice Lake
      • Stevens Point, Wisconsin, United States, 54482
        • Marshfield Clinic Stevens Point Center
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Regional Cancer Center
      • Wausau, Wisconsin, United States, 54401
        • Marshfield Clinic-Wausau Center
      • Weston, Wisconsin, United States, 54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Aspirus Cancer Care - Wisconsin Rapids
      • 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:

  • PRIOR TO STEP 1 REGISTRATION:
  • Patients must have prior history of rectosigmoid colon cancer or rectal cancer
  • Patients must have a post-surgical permanent ostomy or anastomosis
  • Patient's last date of treatment for rectal cancer (any surgery, chemotherapy, radiation therapy) must be at least 6 months prior to registration and not more than 24 months prior to registration
  • Anastomosis patients must have low anterior resection syndrome (LARS) score of 21-42 (minor to major symptoms) within 5 calendar days prior to registration
  • Patient must have completed all baseline questionnaires within 5 days prior to registration
  • Patients must be able to read, write and speak English. Study materials and telephone calls are only available in English
  • Patients with a prior malignancy or concurrent malignancy that is currently not being treated, whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Patients who are currently undergoing treatment for another cancer will have a different symptom profile than what this study is targeting and are not eligible
  • Patients who have been diagnosed with inflammatory bowel disease (IBD), such as ulcerative colitis or Crohn's disease, are not eligible
  • PRIOR TO STEP 2 REGISTRATION:
  • Patient must meet all eligibility criteria for step 1
  • Patient must have successfully completed ("pass") the run-in period, as per email notification from the University of Arizona
  • Patient must be registered to step 2 no more than 40 days after step 1 registration. If day 40 falls on a weekend or holiday, the limit may be extended to the next working day
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (diet modification coaching, motivational messages)
Patients receive diet modification coaching via telephone for 10 sessions over 30-60 minutes over 17 weeks. Patients also receive 3 motivational messages per week via email and/or text message beginning after session 6.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Dietary supplement: Dietary Intervention
Receive diet modification coaching via phone call
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions
Other: Message
Receive motivational messages via email and/or text message
Active Comparator: Arm II (standard of care, motivational messages)
Patients receive general healthy living education via telephone for 10 sessions over 30-60 minutes over 17 weeks. Patients also receive 3 motivational messages per week via email and/or text message beginning after session 6.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Message
Receive motivational messages via email and/or text message
Other: Best Practice
Receive healthy living education via phone call
Other Names:
  • standard of care
  • standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel Function
Time Frame: At 18 weeks after randomization
Will be measured by the Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (BFI) total score. Score range 18-90. Higher scores indicate better bowel function. Will be conducted according to a modified intention-to-treat principle. Study arm differences in BFI at 18 weeks will be assessed by a linear regression model as a function of randomization assignment, BFI baseline value, and stratification factors.
At 18 weeks after randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motivation
Time Frame: Up to week 26
Will be measured using a 10-item scale assessing motivation to change dietary behaviors in rectal cancer survivors. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Up to week 26
Self-efficacy
Time Frame: Up to week 26
Will be measured using the Patient-Reported Outcomes Measurement Information System Self-Efficacy for Managing Symptoms - Short Form 4a. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Up to week 26
Bowel Function
Time Frame: Up to week 26
Will describe using dietary, urgency, and frequency scales. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Up to week 26
Low Anterior Resection Syndrome (LARS)
Time Frame: Up to week 26
LARS will be measured using the LARS Score. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Up to week 26
Quality of Life-Assessment
Time Frame: Up to week 26
Will be measured by the City of Hope-Quality of Life-Colorectal Cancer. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Up to week 26
Dietary Quality
Time Frame: Up to week 26
Will be based on the Healthy Eating Index 2015. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Up to week 26
Positive and Negative Effects
Time Frame: Up to week 26
Will be measured using the International Positive and Negative Affect Schedule Short Form. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Up to week 26
Feasibility of the Intervention
Time Frame: Up to week 26
Will be measured by the percentage of patients who successfully complete ("pass") the run-in period, and randomized. Accrual rates and feasibility will be summarized.
Up to week 26
Adherence to the Intervention
Time Frame: Up to week 18
Will measure successful completion of intervention or attention control coaching calls. Adherence is defined as completing all five of sessions 1-5 and at least three of sessions 6-10 within 18 weeks after randomization. Study arm differences in adherence will be assessed by chi square tests.
Up to week 18
Retention to the Intervention
Time Frame: Up to week 26
Will be defined by completion of follow-up assessments in step 2, including those administered at follow-up site visits and the dietary recalls. Study arm differences in retention will be assessed by chi square tests.
Up to week 26
Acceptability to the Intervention
Time Frame: Up to week 26
Will be measured using the Acceptability of Intervention measure. Study program acceptability will be compared across arms via t-test.
Up to week 26

Collaborators and Investigators

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

Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Virginia Sun, SWOG Cancer Research Network

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)

February 10, 2020

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

December 18, 2019

First Submitted That Met QC Criteria

December 18, 2019

First Posted (Actual)

December 20, 2019

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S1820 (Other Identifier: CTEP)
  • UG1CA189974 (U.S. NIH Grant/Contract)
  • NCI-2019-04990 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • SWOG-S1820 (Other Identifier: DCP)
  • R21CA236057 (U.S. NIH Grant/Contract)

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.

Clinical Trials on Rectal Carcinoma

Clinical Trials on Quality-of-Life Assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe