Communication Intervention for Fecal Ostomy Surgery (CI-oSurg)

Improving Biopsychosocial Outcomes With a Communication Intervention for Patients Undergoing Fecal Ostomy Surgery

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Ileostomy - Stoma; Colostomy Stoma
• Intervention / Treatment: Behavioral: Communication Intervention for fecal ostomy surgery

Detailed Description

In this study the investigators are trying to understand the feasibility and acceptability of a psychologically informed communication guide for fecal ostomy Surgery with the overall goal of improving biopsychosocial outcomes of patients undergoing fecal ostomy surgery.

An estimated 100,000 people in the US undergo fecal ostomy surgery (colostomy or ileostomy) each year, frequently to address severe symptoms (i.e., obstruction, perforation, and incontinence) due to colorectal cancer, diverticulitis, and pelvic floor dysfunction. Complication rates after fecal ostomy surgery are high (up to 37%) with negative effects on patient and family quality of life. Surgeons do not traditionally identify and address health outcomes patients with serious illness prioritize when making treatment decisions, such as caregiver burden, loss of independence and psychosocial function. Communicating this information is key to address patient anxiety when facing major surgery and ensure caregiver preparedness among patients and families considering fecal ostomy surgery.

Current surgical guidelines support the use of preoperative communication and education interventions to improve psychosocial adjustment after fecal ostomy surgery based on expert opinion. However, little evidence exists evaluating the impact of communication interventions or content needs of patients undergoing fecal ostomy surgery or their family. Despite these guidelines, a recent study notes that inadequate ostomy education remains a frequent concern among patients undergoing fecal ostomy surgery. Furthermore, patients' perception of inadequate education is associated with poor emotional, social, and marital outcomes after surgery. There is a critical need to address this deficit in communication quality between patients undergoing fecal ostomy surgery, their family, and surgical care providers. Our guiding hypothesis is that development of a Communication Intervention for fecal ostomy Surgery (CI-oSurg) is acceptable to patients and clinicians, and will ultimately reduce patient distress and improve quality of life.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fecal ostomy surgery participants receiving the CI-oSurg; 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; This is a educational video-based supportive intervention to address practical skills and adaptation to life with a fecal ostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Acceptability	The intervention acceptability will be assessed by cognitive interviews with participants	4 weeks after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Usability	The intervention usability will be assessed by cognitive interviews with participants	4 weeks after intervention use

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional Distress	Exploratory outcome of Distress reported by patients from 0-10	baseline and 4 weeks after intervention
World Health Organization Brief quality of life evaluation	There are 26 questions with scores ranging from 1-5. For 23 questions higher score is better and for 3 questions a lower score is better.	baseline and 4 weeks after intervention
Hospital Anxiety and Depression Scale	This survey has 14 questions with scores ranging from 1-4. A higher score is better.	baseline and 4 weeks after intervention
Therapy Evaluation Form	This survey has 6 questions with scores ranging from 1-9. A higher score is better.	baseline and 4 weeks after intervention
Client Satisfaction Questionnaire	This survey has 8 questions with scores ranging from 1-4. A higher score is better.	baseline and 4 weeks after intervention

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2024
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): November 1, 2025

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2023P003564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Deidentified data of qualitative interviews will be shared with other researchers upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No