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Behavioral Intervention

Telehealth Intervention for Ostomy Self-Management in Bladder and Colorectal Cancer

Phase 2

Waitlist Available

Led By Virginia Sun, PhD, RN

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 13 and 26 weeks post-randomization

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test a telehealth program for patients with colorectal and bladder cancer who will undergo ostomy surgery. The program involves seven group telehealth sessions before and after surgery to help patients and

Who is the study for?

This trial is for individuals with colorectal or bladder cancer who are undergoing ostomy surgery. It aims to help them and their family caregivers manage the life changes post-surgery through group telehealth sessions.

What is being tested?

The study tests a perioperative ostomy self-management program delivered via telehealth, comparing its effectiveness against standard care in improving quality of life after ostomy surgery.

What are the potential side effects?

Since this trial involves educational and support interventions rather than medications, there are no typical drug side effects; however, participants may experience varying levels of emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery to create an intestinal stoma due to bladder or colorectal cancer.

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I have bladder cancer with an ileal conduit.

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I am 18 years old or older.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 13 and 26 weeks post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 13 and 26 weeks post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 13 and 26 weeks post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Self-Efficacy for Ostomy Self-Management

Other study objectives

Colostomy Impact

Family Caregiver Quality of Life

Feasibility of the Intervention

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of Care ArmExperimental Treatment1 Intervention

Arm 2 involves standard of care, where patients and family caregivers are managed by the oncology care team. Care may include clinic visits for follow-up, cancer directed treatments, referrals to other medical specialties as needed, and institutional ostomy nurse support before and after surgery as needed.

Group II: Periop-OSMT Telehealth Intervention ArmExperimental Treatment1 Intervention

Arm 1 includes the following key components: 1) assignment to a peer ostomate; 2) ostomy self-management skills building delivered through group telehealth sessions and led by trained ostomy nurses and peer ostomates; 3) intervention resource manual. The intervention is delivered through 2 telephone and 5 telehealth sessions over a 16 week period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Telehealth Intervention

2006

N/A

~450

0 / 4Eligibility criteria met