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Completed

NCT Number: NCT06320002

Communication Intervention for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Intervention Acceptability

    Time frame: 4 weeks after the intervention

    The intervention acceptability will be assessed by cognitive interviews with participants

Secondary outcomes

  1. Intervention Usability

    Time frame: 4 weeks after intervention use

    The intervention usability will be assessed by cognitive interviews with participants

Other outcomes

  1. Emotional Distress

    Time frame: baseline and 4 weeks after intervention

    Exploratory outcome of Distress reported by patients from 0-10

  2. World Health Organization Brief quality of life evaluation

    Time frame: baseline and 4 weeks after intervention

    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.

  3. Hospital Anxiety and Depression Scale

    Time frame: baseline and 4 weeks after intervention

    This survey has 14 questions with scores ranging from 1-4. A higher score is better.

  4. Therapy Evaluation Form

    Time frame: baseline and 4 weeks after intervention

    This survey has 6 questions with scores ranging from 1-9. A higher score is better.

  5. Client Satisfaction Questionnaire

    Time frame: baseline and 4 weeks after intervention

    This survey has 8 questions with scores ranging from 1-4. A higher score is better.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: CI-oSurg

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2024
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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