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Completed

NCT Number: NCT03063918

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

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Key information

Conditions

Cancer Survivor Stage I Rectosigmoid Cancer Stage II Rectosigmoid Cancer Stage III Rectosigmoid Cancer

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Arizona Medical Center-University Campus, Tucson, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Informational intervention

Other

Receive a workbook

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Survey Administration

Other

Ancillary studies

Telephone-Based Intervention

Behavioral

Receive personalized dietary intervention

Primary outcomes

  1. Acceptability assessed by semi-structured interview

    Time frame: Up to 6 months

    Will be assessed through qualitative data analysis using conventional content analysis approach.

  2. Bowel function assessed by Memorial Sloan Kettering Cancer Center Bowel Function Tool

    Time frame: Up to 6 months

    Descriptive statistics will be summarized using validated scoring procedures.

  3. Feasibility assessed by patient enrollment

    Time frame: Up to 6 months

    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.

  4. Quality of life assessed by City of Hope-Quality of Life-Colorectal Cancer

    Time frame: Up to 6 months

    Descriptive statistics will be summarized using validated scoring procedures.

Other outcomes

  1. Scores from the Decisional Conflict Scale

    Time frame: Up to 6 months

    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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • Hope Foundation
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 24, 2017
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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