Colon Cancer Clinical Trial

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

Summary

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

95

Study ID:

NCT04205955

Recruitment Status:

Completed

Sponsor:

SWOG Cancer Research Network

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 178 Locations for this study

See Locations Near You

Banner University Medical Center - Tucson
Tucson Arizona, 85719, United States
University of Arizona Cancer Center-North Campus
Tucson Arizona, 85719, United States
UC Irvine Health Cancer Center-Newport
Costa Mesa California, 92627, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
Presbyterian Intercommunity Hospital
Whittier California, 90602, United States
Beebe South Coastal Health Campus
Frankford Delaware, 19945, United States
Helen F Graham Cancer Center
Newark Delaware, 19713, United States
Medical Oncology Hematology Consultants PA
Newark Delaware, 19713, United States
Beebe Health Campus
Rehoboth Beach Delaware, 19971, United States
John Fitzgerald Kennedy Medical Center
Atlantis Florida, 33462, United States
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura Florida, 33180, United States
Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Hawaii Cancer Care - Savio
'Aiea Hawaii, 96701, United States
Pali Momi Medical Center
'Aiea Hawaii, 96701, United States
Queen's Cancer Center - Pearlridge
'Aiea Hawaii, 96701, United States
The Cancer Center of Hawaii-Pali Momi
'Aiea Hawaii, 96701, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu Hawaii, 96813, United States
Queen's Cancer Cenrer - POB I
Honolulu Hawaii, 96813, United States
Queen's Medical Center
Honolulu Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu Hawaii, 96813, United States
Hawaii Cancer Care Inc-Liliha
Honolulu Hawaii, 96817, United States
Queen's Cancer Center - Kuakini
Honolulu Hawaii, 96817, United States
The Cancer Center of Hawaii-Liliha
Honolulu Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu Hawaii, 96826, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue Hawaii, 96766, United States
Saint Joseph Regional Medical Center
Lewiston Idaho, 83501, United States
Rush - Copley Medical Center
Aurora Illinois, 60504, United States
Illinois CancerCare-Bloomington
Bloomington Illinois, 61704, United States
Illinois CancerCare-Canton
Canton Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage Illinois, 62321, United States
Centralia Oncology Clinic
Centralia Illinois, 62801, United States
Northwestern University
Chicago Illinois, 60611, United States
Carle on Vermilion
Danville Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur Illinois, 62526, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Illinois CancerCare-Dixon
Dixon Illinois, 61021, United States
Carle Physician Group-Effingham
Effingham Illinois, 62401, United States
Crossroads Cancer Center
Effingham Illinois, 62401, United States
Illinois CancerCare-Eureka
Eureka Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg Illinois, 61401, United States
Illinois CancerCare-Kewanee Clinic
Kewanee Illinois, 61443, United States
Illinois CancerCare-Macomb
Macomb Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon Illinois, 61938, United States
Illinois CancerCare-Ottawa Clinic
Ottawa Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61636, United States
Illinois CancerCare-Peru
Peru Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton Illinois, 61356, United States
Southern Illinois University School of Medicine
Springfield Illinois, 62702, United States
Springfield Clinic
Springfield Illinois, 62702, United States
Memorial Medical Center
Springfield Illinois, 62781, United States
Carle Cancer Center
Urbana Illinois, 61801, United States
The Carle Foundation Hospital
Urbana Illinois, 61801, United States
Rush-Copley Healthcare Center
Yorkville Illinois, 60560, United States
Mary Greeley Medical Center
Ames Iowa, 50010, United States
McFarland Clinic PC - Ames
Ames Iowa, 50010, United States
McFarland Clinic PC-Boone
Boone Iowa, 50036, United States
Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines Iowa, 50309, United States
Broadlawns Medical Center
Des Moines Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge Iowa, 50501, United States
McFarland Clinic PC-Jefferson
Jefferson Iowa, 50129, United States
McFarland Clinic PC-Marshalltown
Marshalltown Iowa, 50158, United States
Methodist West Hospital
West Des Moines Iowa, 50266, United States
HaysMed University of Kansas Health System
Hays Kansas, 67601, United States
University of Kansas Cancer Center-West
Kansas City Kansas, 66112, United States
University of Kansas Cancer Center
Kansas City Kansas, 66160, United States
Lawrence Memorial Hospital
Lawrence Kansas, 66044, United States
Olathe Health Cancer Center
Olathe Kansas, 66061, United States
University of Kansas Cancer Center-Overland Park
Overland Park Kansas, 66210, United States
University of Kansas Hospital-Indian Creek Campus
Overland Park Kansas, 66211, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood Kansas, 66205, United States
Lafayette Family Cancer Center-EMMC
Brewer Maine, 04412, United States
Maine Medical Partners Surgical Care
Portland Maine, 04102, United States
MMP Surgical Care Casco Bay
Portland Maine, 04102, United States
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
McLaren Cancer Institute-Bay City
Bay City Michigan, 48706, United States
IHA Hematology Oncology Consultants-Brighton
Brighton Michigan, 48114, United States
Saint Joseph Mercy Brighton
Brighton Michigan, 48114, United States
IHA Hematology Oncology Consultants-Canton
Canton Michigan, 48188, United States
Saint Joseph Mercy Canton
Canton Michigan, 48188, United States
IHA Hematology Oncology Consultants-Chelsea
Chelsea Michigan, 48118, United States
Saint Joseph Mercy Chelsea
Chelsea Michigan, 48118, United States
McLaren Cancer Institute-Clarkston
Clarkston Michigan, 48346, United States
Beaumont Hospital - Dearborn
Dearborn Michigan, 48124, United States
Wayne State University/Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Ascension Saint John Hospital
Detroit Michigan, 48236, United States
Great Lakes Cancer Management Specialists-Doctors Park
East China Township Michigan, 48054, United States
Weisberg Cancer Treatment Center
Farmington Hills Michigan, 48334, United States
Beaumont Hospital - Farmington Hills
Farmington Hills Michigan, 48336, United States
McLaren Cancer Institute-Flint
Flint Michigan, 48532, United States
Singh and Arora Hematology Oncology PC
Flint Michigan, 48532, United States
Academic Hematology Oncology Specialists
Grosse Pointe Woods Michigan, 48236, United States
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods Michigan, 48236, United States
Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods Michigan, 48236, United States
McLaren-Greater Lansing
Lansing Michigan, 48910, United States
Mid-Michigan Physicians-Lansing
Lansing Michigan, 48912, United States
McLaren Cancer Institute-Lapeer Region
Lapeer Michigan, 48446, United States
Hope Cancer Clinic
Livonia Michigan, 48154, United States
Saint Mary Mercy Hospital
Livonia Michigan, 48154, United States
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb Michigan, 48044, United States
Mid-Michigan Medical Center - Midland
Midland Michigan, 48670, United States
McLaren Cancer Institute-Central Michigan
Mount Pleasant Michigan, 48858, United States
McLaren Cancer Institute-Northern Michigan
Petoskey Michigan, 49770, United States
McLaren-Port Huron
Port Huron Michigan, 48060, United States
Great Lakes Cancer Management Specialists-Rochester Hills
Rochester Hills Michigan, 48309, United States
William Beaumont Hospital-Royal Oak
Royal Oak Michigan, 48073, United States
William Beaumont Hospital - Troy
Troy Michigan, 48085, United States
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren Michigan, 48093, United States
Saint John Macomb-Oakland Hospital
Warren Michigan, 48093, United States
Huron Gastroenterology PC
Ypsilanti Michigan, 48106, United States
IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti Michigan, 48197, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Cambridge Medical Center
Cambridge Minnesota, 55008, United States
Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Unity Hospital
Fridley Minnesota, 55432, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove Minnesota, 55369, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis Minnesota, 55415, United States
Health Partners Inc
Minneapolis Minnesota, 55454, United States
New Ulm Medical Center
New Ulm Minnesota, 56073, United States
North Memorial Medical Health Center
Robbinsdale Minnesota, 55422, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park Minnesota, 55416, United States
Regions Hospital
Saint Paul Minnesota, 55101, United States
United Hospital
Saint Paul Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee Minnesota, 55379, United States
Lakeview Hospital
Stillwater Minnesota, 55082, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Rice Memorial Hospital
Willmar Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury Minnesota, 55125, United States
Fairview Lakes Medical Center
Wyoming Minnesota, 55092, United States
Saint Francis Medical Center
Cape Girardeau Missouri, 63703, United States
Parkland Health Center - Farmington
Farmington Missouri, 63640, United States
Truman Medical Centers
Kansas City Missouri, 64108, United States
University of Kansas Cancer Center - North
Kansas City Missouri, 64154, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit Missouri, 64064, United States
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City Missouri, 64116, United States
Missouri Baptist Medical Center
Saint Louis Missouri, 63131, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve Missouri, 63670, United States
Missouri Baptist Sullivan Hospital
Sullivan Missouri, 63080, United States
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills Missouri, 63127, United States
Billings Clinic Cancer Center
Billings Montana, 59101, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson Nevada, 89052, United States
OptumCare Cancer Care at Seven Hills
Henderson Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson Nevada, 89074, United States
Las Vegas Urology - Green Valley
Henderson Nevada, 89074, United States
Las Vegas Urology - Pebble
Henderson Nevada, 89074, United States
Urology Specialists of Nevada - Green Valley
Henderson Nevada, 89074, United States
Las Vegas Urology - Pecos
Las Vegas Nevada, 89074, United States
OptumCare Cancer Care at Charleston
Las Vegas Nevada, 89102, United States
Hope Cancer Care of Nevada
Las Vegas Nevada, 89103, United States
Radiation Oncology Centers of Nevada Central
Las Vegas Nevada, 89106, United States
Urology Specialists of Nevada - Central
Las Vegas Nevada, 89106, United States
Las Vegas Urology - Sunset
Las Vegas Nevada, 89113, United States
Urology Specialists of Nevada - Southwest
Las Vegas Nevada, 89113, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas Nevada, 89128, United States
Las Vegas Urology - Cathedral Rock
Las Vegas Nevada, 89128, United States
Las Vegas Urology - Smoke Ranch
Las Vegas Nevada, 89128, United States
OptumCare Cancer Care at MountainView
Las Vegas Nevada, 89128, United States
Urology Specialists of Nevada - Northwest
Las Vegas Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas Nevada, 89144, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89148, United States
OptumCare Cancer Care at Fort Apache
Las Vegas Nevada, 89148, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas Nevada, 89169, United States
Lovelace Medical Center-Saint Joseph Square
Albuquerque New Mexico, 87102, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87102, United States
Strecker Cancer Center-Belpre
Belpre Ohio, 45714, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati Ohio, 45219, United States
Mount Carmel East Hospital
Columbus Ohio, 43213, United States
Columbus Oncology and Hematology Associates Inc
Columbus Ohio, 43214, United States
The Mark H Zangmeister Center
Columbus Ohio, 43219, United States
Mount Carmel Health Center West
Columbus Ohio, 43222, United States
Mount Carmel Grove City Hospital
Grove City Ohio, 43123, United States
Marietta Memorial Hospital
Marietta Ohio, 45750, United States
University of Cincinnati Cancer Center-West Chester
West Chester Ohio, 45069, United States
Saint Ann's Hospital
Westerville Ohio, 43081, United States
Cancer Centers of Southwest Oklahoma Research
Lawton Oklahoma, 73505, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Lehigh Valley Hospital-Cedar Crest
Allentown Pennsylvania, 18103, United States
Asplundh Cancer Pavilion
Willow Grove Pennsylvania, 19090, United States
AnMed Health Cancer Center
Anderson South Carolina, 29621, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs South Carolina, 29316, United States
Prisma Health Cancer Institute - Butternut
Greenville South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca
Seneca South Carolina, 29672, United States
M D Anderson Cancer Center
Houston Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
Virginia Cancer Institute
Richmond Virginia, 23230, United States
VCU Massey Cancer Center at Stony Point
Richmond Virginia, 23235, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States
VCU Community Memorial Health Center
South Hill Virginia, 23970, United States
Shenandoah Oncology PC
Winchester Virginia, 22601, United States
Valley Health / Winchester Medical Center
Winchester Virginia, 22601, United States
Skagit Valley Hospital Regional Cancer Care Center
Mount Vernon Washington, 98274, United States
Virginia Mason Medical Center
Seattle Washington, 98101, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
University of Washington Medical Center - Montlake
Seattle Washington, 98195, United States
Olympic Medical Cancer Care Center
Sequim Washington, 98384, United States
Wenatchee Valley Hospital and Clinics
Wenatchee Washington, 98801, United States
Langlade Hospital and Cancer Center
Antigo Wisconsin, 54409, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls Wisconsin, 54729, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire Wisconsin, 54701, United States
Marshfield Clinic - Ladysmith Center
Ladysmith Wisconsin, 54848, United States
Marshfield Medical Center-Marshfield
Marshfield Wisconsin, 54449, United States
Aspirus Medford Hospital
Medford Wisconsin, 54451, United States
Marshfield Clinic-Minocqua Center
Minocqua Wisconsin, 54548, United States
Cancer Center of Western Wisconsin
New Richmond Wisconsin, 54017, United States
Marshfield Medical Center-Rice Lake
Rice Lake Wisconsin, 54868, United States
Marshfield Clinic Stevens Point Center
Stevens Point Wisconsin, 54482, United States
Aspirus Regional Cancer Center
Wausau Wisconsin, 54401, United States
Marshfield Clinic-Wausau Center
Wausau Wisconsin, 54401, United States
Marshfield Medical Center - Weston
Weston Wisconsin, 54476, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids Wisconsin, 54494, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids Wisconsin, 54494, United States
FHP Health Center-Guam
Tamuning , 96913, Guam

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

95

Study ID:

NCT04205955

Recruitment Status:

Completed

Sponsor:


SWOG Cancer Research Network

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider