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.
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.
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
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There are 178 Locations for this study
Tucson Arizona, 85719, United States
Tucson Arizona, 85719, United States
Costa Mesa California, 92627, United States
Duarte California, 91010, United States
Orange California, 92868, United States
Whittier California, 90602, United States
Frankford Delaware, 19945, United States
Newark Delaware, 19713, United States
Newark Delaware, 19713, United States
Rehoboth Beach Delaware, 19971, United States
Atlantis Florida, 33462, United States
Aventura Florida, 33180, United States
Miami Beach Florida, 33140, United States
'Aiea Hawaii, 96701, United States
'Aiea Hawaii, 96701, United States
'Aiea Hawaii, 96701, United States
'Aiea Hawaii, 96701, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96826, United States
Lihue Hawaii, 96766, United States
Lewiston Idaho, 83501, United States
Aurora Illinois, 60504, United States
Bloomington Illinois, 61704, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Centralia Illinois, 62801, United States
Chicago Illinois, 60611, United States
Danville Illinois, 61832, United States
Decatur Illinois, 62526, United States
Decatur Illinois, 62526, United States
Dixon Illinois, 61021, United States
Effingham Illinois, 62401, United States
Effingham Illinois, 62401, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Kewanee Illinois, 61443, United States
Macomb Illinois, 61455, United States
Mattoon Illinois, 61938, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61636, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62781, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Yorkville Illinois, 60560, United States
Ames Iowa, 50010, United States
Ames Iowa, 50010, United States
Boone Iowa, 50036, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Fort Dodge Iowa, 50501, United States
Jefferson Iowa, 50129, United States
Marshalltown Iowa, 50158, United States
West Des Moines Iowa, 50266, United States
Hays Kansas, 67601, United States
Kansas City Kansas, 66112, United States
Kansas City Kansas, 66160, United States
Lawrence Kansas, 66044, United States
Olathe Kansas, 66061, United States
Overland Park Kansas, 66210, United States
Overland Park Kansas, 66211, United States
Westwood Kansas, 66205, United States
Brewer Maine, 04412, United States
Portland Maine, 04102, United States
Portland Maine, 04102, United States
Ann Arbor Michigan, 48106, United States
Bay City Michigan, 48706, United States
Brighton Michigan, 48114, United States
Brighton Michigan, 48114, United States
Canton Michigan, 48188, United States
Canton Michigan, 48188, United States
Chelsea Michigan, 48118, United States
Chelsea Michigan, 48118, United States
Clarkston Michigan, 48346, United States
Dearborn Michigan, 48124, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48236, United States
East China Township Michigan, 48054, United States
Farmington Hills Michigan, 48334, United States
Farmington Hills Michigan, 48336, United States
Flint Michigan, 48532, United States
Flint Michigan, 48532, United States
Grosse Pointe Woods Michigan, 48236, United States
Grosse Pointe Woods Michigan, 48236, United States
Grosse Pointe Woods Michigan, 48236, United States
Lansing Michigan, 48910, United States
Lansing Michigan, 48912, United States
Lapeer Michigan, 48446, United States
Livonia Michigan, 48154, United States
Livonia Michigan, 48154, United States
Macomb Michigan, 48044, United States
Midland Michigan, 48670, United States
Mount Pleasant Michigan, 48858, United States
Petoskey Michigan, 49770, United States
Port Huron Michigan, 48060, United States
Rochester Hills Michigan, 48309, United States
Royal Oak Michigan, 48073, United States
Troy Michigan, 48085, United States
Warren Michigan, 48093, United States
Warren Michigan, 48093, United States
Ypsilanti Michigan, 48106, United States
Ypsilanti Michigan, 48197, United States
Burnsville Minnesota, 55337, United States
Cambridge Minnesota, 55008, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Maple Grove Minnesota, 55369, United States
Maplewood Minnesota, 55109, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Minneapolis Minnesota, 55454, United States
New Ulm Minnesota, 56073, United States
Robbinsdale Minnesota, 55422, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Shakopee Minnesota, 55379, United States
Stillwater Minnesota, 55082, United States
Waconia Minnesota, 55387, United States
Willmar Minnesota, 56201, United States
Woodbury Minnesota, 55125, United States
Wyoming Minnesota, 55092, United States
Cape Girardeau Missouri, 63703, United States
Farmington Missouri, 63640, United States
Kansas City Missouri, 64108, United States
Kansas City Missouri, 64154, United States
Lee's Summit Missouri, 64064, United States
North Kansas City Missouri, 64116, United States
Saint Louis Missouri, 63131, United States
Sainte Genevieve Missouri, 63670, United States
Sullivan Missouri, 63080, United States
Sunset Hills Missouri, 63127, United States
Billings Montana, 59101, United States
Henderson Nevada, 89052, United States
Henderson Nevada, 89052, United States
Henderson Nevada, 89074, United States
Henderson Nevada, 89074, United States
Henderson Nevada, 89074, United States
Henderson Nevada, 89074, United States
Las Vegas Nevada, 89074, United States
Las Vegas Nevada, 89102, United States
Las Vegas Nevada, 89103, United States
Las Vegas Nevada, 89106, United States
Las Vegas Nevada, 89106, United States
Las Vegas Nevada, 89113, United States
Las Vegas Nevada, 89113, United States
Las Vegas Nevada, 89128, United States
Las Vegas Nevada, 89128, United States
Las Vegas Nevada, 89128, United States
Las Vegas Nevada, 89128, United States
Las Vegas Nevada, 89128, United States
Las Vegas Nevada, 89144, United States
Las Vegas Nevada, 89148, United States
Las Vegas Nevada, 89148, United States
Las Vegas Nevada, 89169, United States
Albuquerque New Mexico, 87102, United States
Albuquerque New Mexico, 87102, United States
Belpre Ohio, 45714, United States
Cincinnati Ohio, 45219, United States
Columbus Ohio, 43213, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43219, United States
Columbus Ohio, 43222, United States
Grove City Ohio, 43123, United States
Marietta Ohio, 45750, United States
West Chester Ohio, 45069, United States
Westerville Ohio, 43081, United States
Lawton Oklahoma, 73505, United States
Oklahoma City Oklahoma, 73104, United States
Allentown Pennsylvania, 18103, United States
Willow Grove Pennsylvania, 19090, United States
Anderson South Carolina, 29621, United States
Boiling Springs South Carolina, 29316, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29615, United States
Greer South Carolina, 29650, United States
Seneca South Carolina, 29672, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Richmond Virginia, 23230, United States
Richmond Virginia, 23235, United States
Richmond Virginia, 23298, United States
South Hill Virginia, 23970, United States
Winchester Virginia, 22601, United States
Winchester Virginia, 22601, United States
Mount Vernon Washington, 98274, United States
Seattle Washington, 98101, United States
Seattle Washington, 98109, United States
Seattle Washington, 98109, United States
Seattle Washington, 98195, United States
Sequim Washington, 98384, United States
Wenatchee Washington, 98801, United States
Antigo Wisconsin, 54409, United States
Chippewa Falls Wisconsin, 54729, United States
Eau Claire Wisconsin, 54701, United States
Ladysmith Wisconsin, 54848, United States
Marshfield Wisconsin, 54449, United States
Medford Wisconsin, 54451, United States
Minocqua Wisconsin, 54548, United States
New Richmond Wisconsin, 54017, United States
Rice Lake Wisconsin, 54868, United States
Stevens Point Wisconsin, 54482, United States
Wausau Wisconsin, 54401, United States
Wausau Wisconsin, 54401, United States
Weston Wisconsin, 54476, United States
Wisconsin Rapids Wisconsin, 54494, United States
Wisconsin Rapids Wisconsin, 54494, United States
Tamuning , 96913, Guam
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