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A Supportive Care Program (periop-OSMT) for the Improvement of Ostomy Self-Management, Distress, and Quality of Life in Cancer Survivors and Caregivers
Trial Status: active
This clinical trial studies whether a program to support ostomy self-care before and after surgery (perioperative) is better than standard perioperative care at improving ostomy self-management, distress, and quality of life in patients and their caregivers. Undergoing surgery to create an opening (a stoma) from an area inside the body to the outside (ostomy/urostomy) and coping with recovery can be a life-changing event for both patients and their support persons/caregivers. Standard perioperative care includes one visit or telephone call with a nurse before and after surgery as well as written material on post-operative care. The perioperative ostomy self-management telehealth (periop-OSMT) intervention is a program that supports ostomy self-care by providing educational sessions regarding ostomy self-care and taking care of patients with cancer and an ostomy before and after surgery. The program may improve ostomy self-care skills, confidence in ostomy self-care, and allow patients and their caregivers to adjust more effectively to the ostomy, which may reduce distress and improve quality of life. Participating in the periop-OSMT program may be better than standard perioperative care at improving ostomy self-management, distress, and quality of life in patients and their caregivers.
Inclusion Criteria
PATIENT: Documented verbal consent (when applicable) and written informed consent of the participant
* Assent, when appropriate, will be obtained per institutional guidelines
PATIENT: Age: ≥ 18 years
PATIENT: Ability to read and understand English for questionnaires
PATIENT: Patient with any solid tumors
PATIENT: Scheduled to undergo a surgical procedure that includes the creation of an intestinal stoma (fecal or urinary)
PATIENT: Both patients with permanent or temporary ostomies are eligible
PATIENT: For bladder cancer, only patients with incontinent urostomies (ileal conduit) are eligible
SUPPORT PERSON/FCGs: Patient participation is allowed without a support person/FCG
SUPPORT PERSON/FCGs: Documented verbal consent (when applicable) and written informed consent of the participant
* Assent, when appropriate, will be obtained per institutional guidelines
SUPPORT PERSON/FCGs: Age: ≥ 18 years
SUPPORT PERSON/FCGs: Ability to read and understand English for questionnaires
SUPPORT PERSON/FCGs: A family member or friend identified by the patient and defined as a person who knows the patient well and is involved in the patient’s care before and after surgery
SUPPORT PERSON/FCGs: Pregnant FCGs are eligible for participation. Participation in this behavioral/educational intervention should not impact the pregnancy/fetus
Exclusion Criteria
PATIENT OR FCG: An employee who is under the direct/ indirect supervision of the principal investigator (PI)/ a co-investigator
PATIENT OR FCG: A direct study team member
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06528990.
I. Compare patient-reported self-efficacy for ostomy self-management behaviors at 13 weeks post-randomization.
SECONDARY OBJECTIVES:
I. Assess the feasibility of the intervention.
II. Compare patient activation, patient and family caregiver (FCG)/support person’s psychological distress, patient and FCG/support person’s health-related quality of life (HRQOL).
III. In ostomates with rectal cancer, assess colostomy impact score.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP A: Patients attend 7 telehealth ostomy self-care sessions over 20-120 minutes before and after surgery over 3 months. Patients also receive an assignment to a peer ostomate, an intervention resource manual, and standard perioperative care on study. Support persons/FCGs attend 4 telehealth caregiver sessions over 20-120 minutes before and after surgery over 3 months on study.
GROUP B: Patients and support persons/FCGs receive standard perioperative care only consisting of one visit or telephone call with a nurse before and after surgery as well as written materials on post-operative care on study.
After completion of study intervention, participants are followed up at 13- and 26-weeks post-discharge.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationCity of Hope Comprehensive Cancer Center
