Communication Intervention for Fecal Ostomy Surgery

NCT06320002 | Completed

• 1 other identifier: 2023P003564
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators will evaluate the acceptability of a communication intervention for fecal ostomy surgery (CI-oSurg) to address the needs of adults who are undergoing fecal ostomy surgery. The investigators will recruit 24 patients and 4 clinicians (surgical nurses, wound ostomy nurses). At least half of patients are 65 years or older to understand the unique needs of older adults recovering from fecal ostomy surgery that might impact intervention acceptability. Questionnaires will be administered at two time-points for patient participants: upon study start and 4 weeks after exposure to the intervention.

Conditions

Surgery; Colostomy Stoma; Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

• Intervention Acceptability

  The intervention acceptability will be assessed by cognitive interviews with participants

  4 weeks after the intervention

Secondary Outcomes (1)

• Intervention Usability

  4 weeks after intervention use

Other Outcomes (5)

• Emotional Distress

  baseline and 4 weeks after intervention

• World Health Organization Brief quality of life evaluation

  baseline and 4 weeks after intervention

• Hospital Anxiety and Depression Scale

  baseline and 4 weeks after intervention

Study Arms (1)

Fecal ostomy surgery participants receiving the CI-oSurg

EXPERIMENTAL

This arm will include patients who are undergoing or have undergone fecal ostomy surgery and surgical clinicians caring for the patients who will receive the CI-oSurg intervention.

Behavioral: Communication Intervention for fecal ostomy surgery

Interventions

Communication Intervention for fecal ostomy surgery BEHAVIORAL

This is a educational video-based supportive intervention to address practical skills and adaptation to life with a fecal ostomy

Fecal ostomy surgery participants receiving the CI-oSurg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• English fluency and literacy
• Patient planned to undergo elective fecal ostomy surgery

You may not qualify if:

• Deemed inappropriate by the surgery team
• Unable to provide consent due to severe cognitive impairment or physiologic status (septic shock/intubated)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Cauley CE, Rubio A, Brindle M, Cooper Z, Vranceanu AM, Ritchie CS. A Video-Based Communication Intervention for Fecal Ostomy Surgery (CI-oSurg): Protocol for Open Pilot Testing to Improve Intervention Acceptability and Feasibility. JMIR Res Protoc. 2024 Nov 15;13:e60575. doi: 10.2196/60575.

  PMID: 39546348 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 20, 2024
• Study Start: June 13, 2024
• Primary Completion: April 30, 2025
• Study Completion: November 1, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

US (1)