Personalized Dietary Intervention in Managing Bowel Dysfunction and Improving Quality of Life in Stage I-III Rectosigmoid Cancer Survivors

Not Applicable

Completed

• Conditions: Stage I Rectosigmoid Cancer; Cancer Survivor; Stage II Rectosigmoid Cancer; Stage III Rectosigmoid Cancer
• Interventions: Other: Informational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration; Behavioral: Telephone-Based Intervention

• Registration Number: NCT03063918
• Lead Sponsor: City of Hope Medical Center

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.

Study Timeline

• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-02-24
• Study Start: 2017-04-28
• Primary Completion: 2021-09-07
• Study Completion: 2021-09-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (personalized dietary intervention)	Informational Intervention	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.
Supportive Care (personalized dietary intervention)	Survey Administration	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.
Supportive Care (personalized dietary intervention)	Telephone-Based Intervention	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.
Supportive Care (personalized dietary intervention)	Quality-of-Life Assessment	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.
Supportive Care (personalized dietary intervention)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Acceptability assessed by semi-structured interview	Up to 6 months	Will be assessed through qualitative data analysis using conventional content analysis approach.
Quality of life assessed by City of Hope-Quality of Life-Colorectal Cancer	Up to 6 months	Descriptive statistics will be summarized using validated scoring procedures.
Bowel function assessed by Memorial Sloan Kettering Cancer Center Bowel Function Tool	Up to 6 months	Descriptive statistics will be summarized using validated scoring procedures.
Feasibility assessed by patient enrollment	Up to 6 months	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.

Trial Locations

Locations (2)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States

The University of Arizona Medical Center-University Campus; 🇺🇸 Tucson, Arizona, United States