RightFit
RecruitingPhase 2

Telehealth Intervention for Ostomy Self-Management

Perioperative Ostomy Self-Management Telehealth Intervention for Cancer Survivors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a program to help people with colon, rectal, or bladder cancer and their family caregivers manage an ostomy. An ostomy is an opening made by surgery that lets body waste flow into an outside pouch. The program has seven group video visits before and after surgery to see how well it works and whether a larger study is practical.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Patients must have colon, rectal, or bladder cancer.
  • Patients must be scheduled for surgery to make an ostomy for stool or urine. It may be temporary or permanent.
  • Patients with bladder cancer must be getting an ileal conduit, which uses a piece of bowel to let urine drain into an outside pouch.
  • Patients and caregivers must be age 18 or older.
  • Patients and caregivers must be able to read and understand English to fill out study forms.
  • Caregivers must be a family member or friend chosen by the patient who knows them well and helps with care before and after surgery.
  • Pregnant caregivers may join.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official 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.

    Study sites (1)

    CA