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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
10
Receive a workbook
Ancillary studies
Ancillary studies
Ancillary studies
Receive personalized dietary intervention
The University of Arizona Medical Center-University Campus
Tucson, Arizona, United States
City of Hope Medical Center
Duarte, California, United States
Acceptability assessed by semi-structured interview
Will be assessed through qualitative data analysis using conventional content analysis approach.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 months
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