Recruiting
Early Phase 1

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT07424586

Conditions

Ostomy - Ileostomy or Colostomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT07424586

Start date

Feb 11, 2026

Status verified date

Jun, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: GA-STOMA

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

Interventions

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

Primary outcome measure

  • Acceptability [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Christy Cauley, MD, MPH

617-726-8129ccauley@mgb.org

Jana Zeineddine, MD

617-726-8129ccauley@mgb.org

Locations

MassGeneral Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Christy Cauley, MD, MPH

617-726-8129ccauley@mgb.org

Principal Investigator:

Christy Cauley, MD, MPH

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-06-15.