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

City of Hope

Status: Completed

Conditions: Stage III Rectosigmoid Cancer; Stage II Rectosigmoid Cancer; Cancer Survivor; Stage I Rectosigmoid Cancer

Treatments: Other: Informational Intervention; Behavioral: Telephone-Based Intervention; Other: Survey Administration; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03063918

NCI-2017-00258 (Registry Identifier)

16332 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Supportive Care (personalized dietary intervention)

Experimental group

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.

Treatment:

Other: Quality-of-Life Assessment

Other: Informational Intervention

Other: Questionnaire Administration

Behavioral: Telephone-Based Intervention

Other: Survey Administration