Improving communication for patients undergoing fecal ostomy surgery
Improving Biopsychosocial Outcomes With a Communication Intervention for Patients Undergoing Fecal Ostomy Surgery
NA · Massachusetts General Hospital · NCT06320002
This study tests a new way to help adults, especially older ones, better understand and prepare for fecal ostomy surgery to see if it can reduce their anxiety and improve their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06320002 on ClinicalTrials.gov |
What this trial studies
This study evaluates the acceptability of a communication intervention designed for adults undergoing fecal ostomy surgery. The intervention aims to address the unique needs of patients, particularly older adults, by improving their biopsychosocial outcomes. A total of 24 patients and 4 clinicians will participate, with questionnaires administered at the start and four weeks after the intervention to assess its feasibility and acceptability. The study seeks to enhance patient understanding and preparedness for surgery, ultimately aiming to reduce anxiety and improve quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are planning to undergo elective fecal ostomy surgery and are fluent in English.
Not a fit: Patients who are deemed inappropriate for surgery by the surgical team or those unable to provide consent due to severe cognitive impairment or critical health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life and psychosocial outcomes for patients undergoing fecal ostomy surgery.
How similar studies have performed: While current surgical guidelines support preoperative communication interventions, there is limited evidence on the effectiveness of such interventions specifically for fecal ostomy surgery, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 or older 2. English fluency and literacy 3. Patient planned to undergo elective fecal ostomy surgery Exclusion Criteria: 1. Deemed inappropriate by the surgery team 2. Unable to provide consent due to severe cognitive impairment or physiologic status (septic shock/intubated)
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Christy Cauley, MD, MPH
- Email: ccauley@mgh.harvard.edu
- Phone: 6177268129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Surgery, Colostomy Stoma, Ileostomy - Stoma