Improving Outcomes of Older Adults Undergoing Ostomy Surgery

February 14, 2026 updated by: Christy E. Cauley, MD, MPH, Massachusetts General Hospital

Improving Biopsychosocial Outcomes of Older Adults Undergoing Fecal Ostomy Surgery

The goal of this pilot study is to learn if an intervention in patients undergoing ostomy surgery is easy to use. The overall goal of the work is to improve quality of life during recovery in the days after surgery for these patients using the intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study we are trying to understand the acceptability and usability of an intervention to evaluate and address biopsychosocial outcomes for older adults undergoing fecal ostomy surgery with the overall goal of improving patient-centered outcomes.

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Christy Cauley, MD, MPH
  • Phone Number: 617-726-8129
  • Email: ccauley@mgb.org

Study Contact Backup

  • Name: Jana Zeineddine, MD
  • Phone Number: 617-726-8129
  • Email: ccauley@mgb.org

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • MassGeneral Hospital
        • Contact:
          • Christy Cauley, MD, MPH
          • Phone Number: 617-726-8129
          • Email: ccauley@mgb.org
        • Principal Investigator:
          • Christy Cauley, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients Age 65+ years
  • clinicians age 18+ years
  • Patients undergoing fecal ostomy surgery and their clinicians

Exclusion Criteria:

  • cognitive impairment not allowing completion of consent procedures based on the teach-back method.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GA-STOMA
Participants will be provided a web-based intervention in addition to routine surgical care.
Behavioral: Geriatric Assessment Strategy for Ostomy Management and Adaptation (GA-STOMA)
The web-based intervention provides patients with a survey and tailored content with the purpose of better supporting recovery and adaptation after surgery with a fecal ostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: 6 weeks
Interviews will be performed to assess the participants ability to use the intervention, complete questions, obtain management recommendations and complete management recommendations.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Client Satisfaction questionnaire
Time Frame: 6 weeks after surgery date
This is a quantitative evaluation of intervention acceptability
6 weeks after surgery date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Christy Cauley, MD, MPH, MassGeneral Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

February 14, 2026

First Submitted That Met QC Criteria

February 14, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 14, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025P002770
  • K76AG088346 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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