Personalized Dietary Intervention in Managing Bowel Dysfunction and Improving Quality of Life in Stage I-III Rectosigmoid Cancer Survivors
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 1/2/2019 |
| Start Date: | April 28, 2017 |
| End Date: | December 2019 |
Pilot Study of a Personalized Dietary Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors
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.
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.
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.
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
We found this trial at
2
sites
Duarte, California 91010
Principal Investigator: Virginia Sun, PhD, RN
Phone: 626-256-4673
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Tucson, Arizona 85724
Principal Investigator: Cynthia Thomson, PhD, RDN
Phone: 520-626-1565
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