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Recruiting NCT07424586

Improving Outcomes of Older Adults Undergoing Ostomy Surgery

Early Phase I Interventional Ostomy - Ileostomy or Colostomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Geriatric Assessment Strategy for Ostomy Management and Adaptation (GA-STOMA).
Who it may be relevant to
Registry conditions: Ostomy - Ileostomy or Colostomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Improving Biopsychosocial Outcomes of Older Adults Undergoing Fecal Ostomy Surgery

Overview

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.

Detailed description

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.

Interventions

  • 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

Primary outcome measures

  • Acceptability [Time frame: 6 weeks]
Secondary outcome measures (1)
  • Client Satisfaction questionnaire [Time frame: 6 weeks after surgery date]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • MassGeneral Hospital — Boston

Identifiers

NCT: NCT07424586 · 2025P002770 · K76AG088346

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗