Improving recovery and quality of life after ostomy surgery for older adults
Official title: Improving Biopsychosocial Outcomes of Older Adults Undergoing Fecal Ostomy Surgery
Run by Massachusetts General Hospital · NCT07424586 · Data updated 2026-11-12
This pilot tests a web-based geriatric assessment program to help adults age 65+ recover and maintain quality of life after ileostomy or colostomy surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 16 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | February 11, 2026 |
| Main results expected | October 1, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT07424586 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults age 65 or older who are scheduled for a fecal ostomy (ileostomy or colostomy), can complete consent and web-based interactions, and are receiving care at the study site, along with their clinicians.
✕Probably not a fit
Patients with cognitive impairment that prevents completion of consent via the teach-back method or those not treated at the study site are unlikely to be eligible or to benefit from this pilot.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase interventional pilot is testing the Geriatric Assessment Strategy for Ostomy Management and Adaptation (GA-STOMA) for acceptability and usability in older adults undergoing fecal ostomy surgery. Participants are patients age 65 and older who are having ileostomy or colostomy surgery, together with their clinicians, and the intervention is delivered via a web-based platform with perioperative follow-up in the days after surgery. The study will collect usability and acceptability data along with biopsychosocial and patient-centered recovery outcomes to inform refinements. The work is being conducted at Massachusetts General Hospital and is intended to determine whether the intervention is easy to use and feasible before larger trials.
Why it matters
Potential benefit: If successful, the program could improve early recovery and quality of life after ostomy surgery by providing tailored biopsychosocial support to older patients.
How similar studies have gone: Web-based and geriatric assessment interventions have shown promise improving post-surgical and quality-of-life outcomes in older adults more broadly, but few prior studies have specifically targeted older patients receiving new fecal ostomies, so this application is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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MassGeneral Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Christy Cauley, MD, MPH — MassGeneral Hospital
- Study coordinator: Christy Cauley, MD, MPH
- Email: ccauley@mgb.org
- Phone: 617-726-8129
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Teach-back education for people with ostomies to improve self-care and adjustment
This study tests whether teaching ostomy care using the Teach-back method helps adults with ostomies feel more able to care for themselves and adjust, and reduces anxiety.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.