Personalized Dietary Intervention in Managing Bowel Dysfunction and Improving Quality of Life in Stage I-III Rectosigmoid Cancer Survivors
Primary Purpose
Cancer Survivor, Stage I Rectosigmoid Cancer, Stage II Rectosigmoid Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Informational Intervention
Quality-of-Life Assessment
Questionnaire Administration
Survey Administration
Telephone-Based Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer Survivor
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of stage I-III cancers of the rectosigmoid colon or rectum
- 6 months post-treatment completion
- Have a permanent ostomy or anastomosis
- English-speaking
- All subjects must have the ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
- Patients with stage IV disease will be excluded from the study
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Sites / Locations
- The University of Arizona Medical Center-University Campus
- City of Hope Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive Care (personalized dietary intervention)
Arm Description
At 6 months after standard of care treatment, patients receive 10 sessions of personalized dietary intervention over 30 minutes each over 4 months via the telephone. Patients also receive a workbook including reference materials and intervention content.
Outcomes
Primary Outcome Measures
Acceptability assessed by semi-structured interview
Will be assessed through qualitative data analysis using conventional content analysis approach.
Bowel function assessed by Memorial Sloan Kettering Cancer Center Bowel Function Tool
Descriptive statistics will be summarized using validated scoring procedures.
Feasibility assessed by patient enrollment
Will be assessed through: 1) the ratio of eligible participants to those enrolled and those who declines participation; 2) reasons for non-participation; 3) number of scheduled study encounters completed; 4) attrition rate between pre- and post-intervention; 5) reasons for attrition/dropout; 6) level of intervention participation including the total number of sessions, number of sessions completed without break-offs, number of break-offs, length (minutes) of sessions; and 7) the ratio of all participants to those who complete >= 80% of the study.
Quality of life assessed by City of Hope-Quality of Life-Colorectal Cancer
Descriptive statistics will be summarized using validated scoring procedures.
Secondary Outcome Measures
Full Information
NCT ID
NCT03063918
First Posted
February 21, 2017
Last Updated
February 19, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI), Hope Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03063918
Brief Title
Personalized Dietary Intervention in Managing Bowel Dysfunction and Improving Quality of Life in Stage I-III Rectosigmoid Cancer Survivors
Official Title
Pilot Study of a Personalized Dietary Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 28, 2017 (Actual)
Primary Completion Date
December 28, 2023 (Anticipated)
Study Completion Date
December 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI), Hope Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This pilot clinical trial studies how well personalized dietary intervention works in managing bowel dysfunction and improving quality of life in stage I-III rectosigmoid cancer survivors. Personalized dietary intervention may help people understand bowel symptoms, identify helpful and troublesome foods for bowel symptoms, adjust diets and food preparation based on food triggers, and coach on healthy diet recommendations after cancer treatment.
Detailed Description
PRIMARY OBJECTIVES:
I. Administer and determine the feasibility of the personalized dietary intervention.
II. Using qualitative methods, evaluate the acceptability of the intervention as reported by survivors.
III. Explore decisional conflict associated with treatment decision-making in rectal cancer surgery.
OUTLINE:
At 6 months after standard of care treatment, patients receive 10 sessions of personalized dietary intervention over 30 minutes each over 4 months via the telephone. Patients also receive a workbook including reference materials and intervention content.
After completion of study, patients are followed up for 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Survivor, Stage I Rectosigmoid Cancer, Stage II Rectosigmoid Cancer, Stage III Rectosigmoid Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supportive Care (personalized dietary intervention)
Arm Type
Experimental
Arm Description
At 6 months after standard of care treatment, patients receive 10 sessions of personalized dietary intervention over 30 minutes each over 4 months via the telephone. Patients also receive a workbook including reference materials and intervention content.
Intervention Type
Other
Intervention Name(s)
Informational Intervention
Intervention Description
Receive a workbook
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Intervention Type
Behavioral
Intervention Name(s)
Telephone-Based Intervention
Intervention Description
Receive personalized dietary intervention
Primary Outcome Measure Information:
Title
Acceptability assessed by semi-structured interview
Description
Will be assessed through qualitative data analysis using conventional content analysis approach.
Time Frame
Up to 6 months
Title
Bowel function assessed by Memorial Sloan Kettering Cancer Center Bowel Function Tool
Description
Descriptive statistics will be summarized using validated scoring procedures.
Time Frame
Up to 6 months
Title
Feasibility assessed by patient enrollment
Description
Will be assessed through: 1) the ratio of eligible participants to those enrolled and those who declines participation; 2) reasons for non-participation; 3) number of scheduled study encounters completed; 4) attrition rate between pre- and post-intervention; 5) reasons for attrition/dropout; 6) level of intervention participation including the total number of sessions, number of sessions completed without break-offs, number of break-offs, length (minutes) of sessions; and 7) the ratio of all participants to those who complete >= 80% of the study.
Time Frame
Up to 6 months
Title
Quality of life assessed by City of Hope-Quality of Life-Colorectal Cancer
Description
Descriptive statistics will be summarized using validated scoring procedures.
Time Frame
Up to 6 months
Other Pre-specified Outcome Measures:
Title
Scores from the Decisional Conflict Scale
Description
Descriptive statistics will be summarized. This analysis is exploratory only. Will use the findings to support future research related to treatment-decision making in rectal cancer.
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of stage I-III cancers of the rectosigmoid colon or rectum
6 months post-treatment completion
Have a permanent ostomy or anastomosis
English-speaking
All subjects must have the ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
Patients with stage IV disease will be excluded from the study
Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Sun, PhD, RN
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Arizona Medical Center-University Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Personalized Dietary Intervention in Managing Bowel Dysfunction and Improving Quality of Life in Stage I-III Rectosigmoid Cancer Survivors
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