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

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.

Study Overview

• Status: Completed
• Conditions: Cancer Survivor; Stage I Rectosigmoid Cancer; Stage II Rectosigmoid Cancer; Stage III Rectosigmoid Cancer
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration; Other: Informational Intervention; Behavioral: Telephone-Based Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • The University of Arizona Medical Center-University Campus
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive Care (personalized dietary intervention); 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Ancillary studies; Other: Informational Intervention; Receive a workbook; Behavioral: Telephone-Based Intervention; Receive personalized dietary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability assessed by semi-structured interview	Will be assessed through qualitative data analysis using conventional content analysis approach.	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.	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.	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.	Up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI); Hope Foundation
• Investigators: Principal Investigator: Virginia Sun, PhD, RN, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2017
• Primary Completion (Actual): September 7, 2021
• Study Completion (Actual): September 7, 2021

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: February 23, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: 16332 (Other Identifier: City of Hope Medical Center); NCI-2017-00258 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No