Clinical trial NCT03063918: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivor
Stage I Rectosigmoid Cancer
Stage II Rectosigmoid Cancer
Stage III Rectosigmoid Cancer
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Hope Foundation
First posted: 2017-02-24
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Acceptability assessed by semi-structured interview
timeFrame: Up to 6 months
measure: Bowel function assessed by Memorial Sloan Kettering Cancer Center Bowel Function Tool
timeFrame: Up to 6 months
measure: Feasibility assessed by patient enrollment
timeFrame: Up to 6 months
measure: Quality of life assessed by City of Hope-Quality of Life-Colorectal Cancer
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
measure: Scores from the Decisional Conflict Scale
timeFrame: Up to 6 months
Locations:
city: Tucson
country: United States
facility: The University of Arizona Medical Center-University Campus
state: Arizona
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Virginia Sun, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: