Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07424586

Improving Outcomes of Older Adults Undergoing 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Ostomy - Ileostomy or Colostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

MassGeneral Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Christy Cauley, MD, MPH

CONTACT

[email protected]

617-726-8129

Christy Cauley, MD, MPH

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Geriatric Assessment Strategy for Ostomy Management and Adaptation (GA-STOMA)

Behavioral

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

Primary outcomes

  1. Acceptability

    Time frame: 6 weeks

    Interviews will be performed to assess the ability to use the intervention, complete questions, obtain management recommendations and complete management recommendations.

Secondary outcomes

  1. Client Satisfaction questionnaire

    Time frame: 6 weeks after surgery date

    This is a quantitative evaluation of intervention acceptability

Study contacts

Contact information is provided by the study sponsor or research team.

Christy Cauley, MD, MPH

CONTACT

[email protected]

617-726-8129

Jana Zeineddine, MD

CONTACT

[email protected]

617-726-8129

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Improving Biopsychosocial Outcomes of Older Adults Undergoing Fecal Ostomy Surgery

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Jun 15, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.