Clinical trial NCT06528990: Telehealth Intervention for Ostomy Self-Management
Official title: Perioperative Ostomy Self-Management Telehealth Intervention for Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Colorectal Cancer
Bladder Cancer
Keywords: Ostomy, colorectal cancer, bladder cancer, quality of liffffffffffffffffffffe, telehealth, family caregivers
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-07-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Over one million individuals in the U.S. have ostomies. An ostomy is a surgical procedure that creates an opening in the abdominal wall that allows bodily waste (urinary or fecal) to pass through into an external pouch; in essence, it is the externalization of the gastrointestinal or urinary structures to the abdominal wall. For cancer, ostomies are most commonly placed for rectal cancers, followed by urinary bladder cancer. The health-related quality of life impact of an ostomy is tremendous and greater than many other cancer treatments. The goal of this study is to pilot-test a perioperative ostomy self-management telehealth intervention (Periop-OSMT) in patients with colorectal and bladder cancer and their family caregivers. Participants will receive seven group telehealth sessions before and after ostomy surgery. This pilot clinical trial will study the feasibility of the methods/interventions and determine the preliminary efficacy to support a larger confirmatory trial.

Detailed description: An ostomy is a disability that adversely affects the HRQOL of cancer survivors and their support persons/family caregivers (FCGs) at all phases of cancer survivorship. More than half of survivors experience stoma-related challenges such as pain, troublesome odor, skin problems around the stoma, and leakage. Ongoing problems include pouching care, travel out of the home (especially relevant for rural populations), social interactions, intimacy, and acceptance of/satisfaction with appearance. Studies document persistent challenges including sexuality, psychological problems, and interference with work, and recreation and sporting activities. The purpose of this study is to assess the feasibility of a perioperative ostomy self-management telehealth intervention (Periop-OSMT) and to determine the preliminary efficacy of the intervention on participant-reported outcomes, compared to the usual care arm. We hypothesize that the intervention will be feasible, acceptable and will demonstrate preliminary improvements in outcomes compared to the usual care arm.

Eligibility criteria: Patient Eligibility Criteria:

* Patient with bladder or colorectal cancer
* Scheduled to undergo a surgical procedure that includes the creation of an intestinal stoma (fecal or urinary, permanent or temporary)
* For bladder cancer, only patients with incontinent urostomies (ileal conduit) are eligible.
* Age: ≥ 18 years
* Ability to read and understand English for Questionnaires

Family Caregiver Eligibility Criteria:

* 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
* Age: ≥ 18 years
* Ability to read and understand English for Questionnaires
* Pregnant FCGs are eligible for participation. Participation in this behavioral/educational intervention should not impact the pregnancy/fetus.

Primary outcomes:
measure: Self-Efficacy for Ostomy Self-Management
timeFrame: At 13 weeks post-randomization
Secondary outcomes:
Other outcomes:
measure: Feasibility of the Intervention
timeFrame: at baseline, 13 weeks, 26 weeks post randomization
measure: Patient Activation
timeFrame: At 13 and 26 weeks post-randomization
measure: Patient and Family Caregiver Psychological Distress
timeFrame: At Baseline, 13 and 26 weeks post-randomization
measure: Quality of Life
timeFrame: At Baseline, 13 and 26 weeks post-randomization
measure: Family Caregiver Quality of Life
timeFrame: At Baseline, 13 and 26 weeks post-randomization
measure: Colostomy Impact
timeFrame: At Baseline, 13 and 26 weeks post-randomization
Locations:
city: Duarte
country: United States
facility: City of hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Virginia Sun, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: