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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach

1 country

2 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.4 years study duration

First Submitted

Initial submission to the registry

February 21, 2017

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2017

Completed

2 months until next milestone

Study Start

First participant enrolled

April 28, 2017

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2021

Completed

Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

4.4 years

First QC Date

February 21, 2017

Last Update Submit

February 20, 2024

Conditions

Cancer Survivor Stage I Rectosigmoid Cancer Stage II Rectosigmoid Cancer Stage III Rectosigmoid Cancer

Outcome Measures

Primary Outcomes (4)

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

Other Outcomes (1)

Scores from the Decisional Conflict Scale
Up to 6 months

Study Arms (1)

Supportive Care (personalized dietary intervention)

EXPERIMENTAL

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.

Other: Informational InterventionOther: Quality-of-Life AssessmentOther: Questionnaire AdministrationOther: Survey AdministrationBehavioral: Telephone-Based Intervention