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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-04990 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| S1820 | Other Identifier | SWOG | |
| SWOG-S1820 | Other Identifier | DCP | |
| S1820 | Other Identifier | CTEP | |
| R21CA236057 | U.S. NIH Grant/Contract | View source | |
| UG1CA189974 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (diet modification coaching, motivational messages) | Experimental | 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 (standard of care, motivational messages) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive healthy living education via phone call |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bowel Function | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Bowel Function | 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. |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia Sun | SWOG Cancer Research Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center - Tucson | Tucson | Arizona | 85719 | United States | ||
| University of Arizona Cancer Center-North Campus |
95 participants were randomly assigned; 48 on the attention control arm and 47 on the intervention arm. Reasons for ineligibility include not completing run-in, withdraw of consent, and disease progression.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Dietary Intervention: Receive diet modification coaching via phone call Message: Receive motivational messages via email and/or text message Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2023 |
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| Dietary Intervention | Dietary Supplement | Receive diet modification coaching via phone call |
|
|
| Message | Other | Receive motivational messages via email and/or text message |
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Up to week 26 |
| Low Anterior Resection Syndrome (LARS) | 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 | 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 | 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 |
| Motivation | 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 | 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 |
| Positive and Negative Effects | 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 | 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 | 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 | 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 | Will be measured using the Acceptability of Intervention measure. Study program acceptability will be compared across arms via t-test. | Up to week 26 |
| 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 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 |
| 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 |
| 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 | 50266-7700 | 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 |
| Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri | 63670 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | 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 |
| FG001 | 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. Best Practice: Receive healthy living education via phone call Message: Receive motivational messages via email and/or text message Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Dietary Intervention: Receive diet modification coaching via phone call Message: Receive motivational messages via email and/or text message Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| BG001 | 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. Best Practice: Receive healthy living education via phone call Message: Receive motivational messages via email and/or text message Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity | Count of Participants | Participants |
| ||||||||||||||||
| Highest Level of Education | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Median | Full Range | kg/m^2 |
| |||||||||||||||
| Body Mass Index (BMI) | Count of Participants | Participants |
| ||||||||||||||||
| Smoking Status | Count of Participants | Participants |
| ||||||||||||||||
| Current Marital Status | Count of Participants | Participants |
| ||||||||||||||||
| Any Change in Marital Status Since Diagnosis | Count of Participants | Participants |
| ||||||||||||||||
| Adjusted Diet because of Surgery/ostomy | Count of Participants | Participants |
| ||||||||||||||||
| Time to Comfort with Diet after your Surgery/ostomy | Count of Participants | Participants |
| ||||||||||||||||
| Time Since Diagnosis | Median | Full Range | months |
| |||||||||||||||
| Type of Cancer | Count of Participants | Participants |
| ||||||||||||||||
| Prior Treatment: Chemotherapy | Count of Participants | Participants |
| ||||||||||||||||
| Prior Treatment: Radiation Therapy | Count of Participants | Participants |
| ||||||||||||||||
| Prior Surgery: Anastomosis | Count of Participants | Participants |
| ||||||||||||||||
| Prior Surgery: Ostomy | Count of Participants | Participants |
| ||||||||||||||||
| Prior Surgery: Temporary Ostomy and Re-anastomosis | Count of Participants | Participants |
| ||||||||||||||||
| Time Since Surgery | Median | Full Range | months |
| |||||||||||||||
| Type of Low Anterior Resection Surgery | Count of Participants | Participants |
| ||||||||||||||||
| LAR Syndrome (LARS) Burden | LAR = Lower Anterior Resection. Valid for anastomosis patients only. Score range 0-42: No LARS (0-20), Minor LARS (21-29), Major LARS (30-42). | Count of Participants | Participants |
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| Zubrod Performance Status | A performance status of 0 is defined as fully active, able to carry on all pre-disease performance without restriction. A performance status of 1 is defined as restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. A performance status of 2 is defined as ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours. | Count of Participants | Participants |
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| Current Medication: Antibiotics | Count of Participants | Participants |
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| Current Medication: Antidiarrheal Medications | Count of Participants | Participants |
| ||||||||||||||||
| Current Medication: Medication for Constipation | Count of Participants | Participants |
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| Current Medication: Probiotics | Count of Participants | Participants |
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| Used Alternative Therapies for Bowel Issues in Past 5 Months | Includes meditation, mindfulness therapy, acupuncture, or other alternative therapies | Count of Participants | Participants |
| |||||||||||||||
| AJCC clinical stage at diagnosis: T Stage | Tx: Unmeasured tumor T1: Tumor is only in the inner layer of the bowel T2: Tumor has grown into the muscle layer of the bowel wall T3: Tumor has grown into the outer lining of the bowel wall T4: Tumor has grown through the bowel wall into near by organs | Count of Participants | Participants |
| |||||||||||||||
| AJCC Clinical Stage at Diagnosis: N Stage | NX: Cancer in nearby lymph nodes cannot be measured. N0: There is no cancer in nearby lymph nodes. N1: One near by lymph node contains cancer. N2: Two near by lymph nodes contain cancer. | Count of Participants | Participants |
| |||||||||||||||
| AJCC Clinical Stage at Diagnosis: M Stage | MX: Metastasis cannot be measured. M0: Cancer has not spread to other parts of the body. M1: Cancer has spread to other parts of the body. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bowel Function | 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. | 95 total participants were randomly assigned; 47 on the intervention arm and 46 on the attention control arm. 3 patients were deemed ineligible for missing assessments and for other ineligibility criteria. This leaves 46 participants on the intervention arm and 44 on the attention control arm. | Posted | Mean | 95% Confidence Interval | MSK-BFI score on a scale (range 18-90) | At 18 weeks after randomization |
|
|
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| Other Pre-specified | Bowel Function | 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. | Not Posted | Up to week 26 | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Low Anterior Resection Syndrome (LARS) | 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. | Not Posted | Up to week 26 | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Quality of Life-Assessment | 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. | Not Posted | Up to week 26 | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Dietary Quality | 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. | Not Posted | Up to week 26 | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Motivation | 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. | Not Posted | Up to week 26 | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Self-efficacy | 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. | Not Posted | Up to week 26 | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Positive and Negative Effects | 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. | Not Posted | Up to week 26 | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Feasibility of the Intervention | 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. | Not Posted | Up to week 26 | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Adherence to the Intervention | 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. | Not Posted | Up to week 18 | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Retention to the Intervention | 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. | Not Posted | Up to week 26 | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Acceptability to the Intervention | Will be measured using the Acceptability of Intervention measure. Study program acceptability will be compared across arms via t-test. | Not Posted | Up to week 26 | Participants |
Adverse Events were not collected
Adverse Events were not collected
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Dietary Intervention: Receive diet modification coaching via phone call Message: Receive motivational messages via email and/or text message Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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. Best Practice: Receive healthy living education via phone call Message: Receive motivational messages via email and/or text message Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Palliative and End of Life Care Committee Statistician | SWOG Statistics and Data Management Center | 2066677685 | karnold@fredhutch.org |
| Feb 14, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 3, 2023 | Feb 14, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| Unknown |
|
| White |
|
| Non-Hispanic |
|
| Unknown |
|
| Completed high school/GED/vocational/secretarial/business |
|
| Any college |
|
| Any graduate school |
|
| 18.5-<25 kg/m^2 (Normal weight) |
|
| 25-<30 kg/m^2 (Overweight) |
|
| >=30 kg/m^2 (Obese) |
|
| Former |
|
| Never |
|
| Unknown |
|
| Married or partnered |
|
| Single |
|
| Widowed |
|
| No |
|
| No |
|
| 1 to 12 months |
|
| More than 12 months |
|
| I am still not comfortable |
|
| Not Answered |
|
| Rectosigmoid colon |
|
| Other |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| Low anterior resection |
|
| Sigmoid colectomy |
|
| Major LARS |
|
| Not applicable, ostomy |
|
| 1 |
|
| 2 |
|
| Missing |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| T2 |
|
| T3 |
|
| T4 |
|
| TX |
|
| N1 |
|
| N2 |
|
| NX |
|
| M1 |
|
| MX |
|
| Missing |
|