Improving Outcomes of Older Adults Undergoing Ostomy Surgery

Improving Biopsychosocial Outcomes of Older Adults Undergoing Fecal Ostomy Surgery

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07424586

Enrollment

Registered

2026-02-20

Start date

2026-02-11

Completion date

2026-11-30

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ostomy - Ileostomy or Colostomy

Keywords

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

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.

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

BEHAVIORALGeriatric 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Acceptability	6 weeks	Interviews will be performed to assess the ability to use the intervention, complete questions, obtain management recommendations and complete management recommendations.

Secondary

Measure	Time frame	Description
Client Satisfaction questionnaire	6 weeks after surgery date	This is a quantitative evaluation of intervention acceptability

Countries

United States

Contacts

CONTACTChristy Cauley, MD, MPH

ccauley@mgb.org617-726-8129

CONTACTJana Zeineddine, MD