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

Cancer Survivor Clinical Trial

Official title:

Pilot Study of a Personalized Dietary Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03063918
• Other study ID #: 16332
• Secondary ID: NCI-2017-0025816
• Status: Completed
• Phase: N/A
• Start date: April 28, 2017
• Est. completion date: September 7, 2021

Study information

• Verified date: February 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 7, 2021
• Est. primary completion date: September 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Survivor
• Intestinal Diseases
• Stage I Rectosigmoid Cancer
• Stage II Rectosigmoid Cancer
• Stage III Rectosigmoid Cancer

Intervention

Other:
• Informational Intervention
Receive a workbook
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies
• Survey Administration
Ancillary studies

Behavioral:
• Telephone-Based Intervention
Receive personalized dietary intervention

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California
United States	The University of Arizona Medical Center-University Campus	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
City of Hope Medical Center	Hope Foundation, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Scores from the Decisional Conflict Scale	Descriptive statistics will be summarized. This analysis is exploratory only. Will use the findings to support future research related to treatment-decision making in rectal cancer.	Up to 6 months
Primary	Acceptability assessed by semi-structured interview	Will be assessed through qualitative data analysis using conventional content analysis approach.	Up to 6 months
Primary	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
Primary	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
Primary	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