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Trial record 1 of 2 for:    s1820
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Testing Diet Intervention Versus Non-Diet Intervention for Management of Bowel Symptoms in Rectal Cancer Survivors

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ClinicalTrials.gov Identifier: NCT04205955
Recruitment Status : Recruiting
First Posted : December 20, 2019
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief 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.

Condition or disease Intervention/treatment Phase
Colon Carcinoma Rectal Carcinoma Rectosigmoid Carcinoma Other: Best Practice Dietary Supplement: Dietary Intervention Other: Message Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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)
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


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.
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

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

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: Best Practice
Receive healthy living education via phone call
Other Names:
  • standard of care
  • standard therapy

Other: Message
Receive motivational messages via email and/or text message

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. 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. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. Quality of life [ 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04205955


Contacts
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Contact: Vanessa Benavidez 210-614-8808 ext 1008 vbenavidez@swog.org
Contact: Dana Sparks 210-614-8808 ext 1004 dsparks@swog.org

Locations
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United States, Iowa
Mary Greeley Medical Center Recruiting
Ames, Iowa, United States, 50010
Contact: Site Public Contact    515-956-4132      
Principal Investigator: Debra M. Prow         
McFarland Clinic PC - Ames Recruiting
Ames, Iowa, United States, 50010
Contact: Site Public Contact    515-239-4734    ksoder@mcfarlandclinic.com   
Principal Investigator: Debra M. Prow         
McFarland Clinic PC-Boone Recruiting
Boone, Iowa, United States, 50036
Contact: Site Public Contact    515-956-4132      
Principal Investigator: Debra M. Prow         
McFarland Clinic PC-Trinity Cancer Center Recruiting
Fort Dodge, Iowa, United States, 50501
Contact: Site Public Contact    515-956-4132      
Principal Investigator: Debra M. Prow         
McFarland Clinic PC-Jefferson Recruiting
Jefferson, Iowa, United States, 50129
Contact: Site Public Contact    515-956-4132      
Principal Investigator: Debra M. Prow         
McFarland Clinic PC-Marshalltown Recruiting
Marshalltown, Iowa, United States, 50158
Contact: Site Public Contact    515-956-4132      
Principal Investigator: Debra M. Prow         
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Virginia Sun Southwest Oncology Group

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Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT04205955    
Other Study ID Numbers: S1820
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 )
UG1CA189974 ( U.S. NIH Grant/Contract )
First Posted: December 20, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms