An Early Phase 1 interventional study of Geriatric Assessment Strategy for Ostomy Management and Adaptation (GA-STOMA) in Ostomy - Ileostomy or Colostomy, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Massachusetts General Hospital · Early Phase 1, Interventional, and Other
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.
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.
Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A web-based intervention will be provided 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
Acceptability
Interviews will be performed to assess the ability to use the intervention, complete questions, obtain management recommendations and complete management recommendations.
Time frame: 6 weeks
Client Satisfaction questionnaire
This is a quantitative evaluation of intervention acceptability
Time frame: 6 weeks after surgery date
Plan to share: No
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Massachusetts General Hospital