Improving Outcomes of Older Adults Undergoing Ostomy Surgery

NCT07424586 | Recruiting Early Phase 1

• 2 other identifiers: 2025P002770K76AG088346
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ostomy - Ileostomy or Colostomy

Keywords

ostomy; quality of life; biopsychosocial outcomes; web-based intervention

Outcome Measures

Primary Outcomes (1)

• Acceptability

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

  6 weeks

Secondary Outcomes (1)

• Client Satisfaction questionnaire

  6 weeks after surgery date

Study Arms (1)

GA-STOMA

EXPERIMENTAL

A web-based intervention will be provided in addition to routine surgical care.

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

Interventions

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

GA-STOMA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

MassGeneral Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Interventions

Acclimatization

Intervention Hierarchy (Ancestors)

Adaptation, Physiological; Physiological Phenomena; Adaptation, Biological; Biological Phenomena

Study Officials

• Christy Cauley, MD, MPH

  MassGeneral Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christy Cauley, MD, MPH

CONTACT

617-726-8129; ccauley@mgb.org

Jana Zeineddine, MD

CONTACT

617-726-8129; ccauley@mgb.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Model Details: Open Pilot of patients and clinicians to assess web-based intervention acceptability and usability.

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: February 20, 2026
• Study Start: February 11, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)