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

Overseen By Virginia Sun, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Disqualifiers: Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is the Telehealth Intervention for Ostomy Self-Management safe for humans?

The available research on telehealth interventions for ostomy self-management in cancer patients does not report any specific safety concerns, suggesting it is generally safe for human use. ^{1 2 3 4 5}

How is the Telehealth Intervention for Ostomy Self-Management treatment different from other treatments for ostomy care in cancer patients?

The Telehealth Intervention for Ostomy Self-Management is unique because it uses telehealth (remote healthcare services) to provide systematic, evidence-based support and education for cancer survivors with ostomies, unlike traditional methods that rely on in-person nurse counseling and community referrals. ^{1 2 5 6 7}

What data supports the effectiveness of the treatment Telehealth Intervention for Ostomy Self-Management?

Research shows that telehealth programs for ostomy self-management, like the Ostomy Self-Management Telehealth program (OSMT), can improve the quality of life for cancer survivors by providing systematic support and education, which is often more effective than traditional care methods. ^{1 2 3 5 6}

Who Is on the Research Team?

Virginia Sun, RN

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I have bladder cancer with an ileal conduit.

Ability to read and understand English for Questionnaires

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Perioperative Ostomy Self-Management Telehealth Intervention

Participants receive ostomy self-management skills building through group telehealth sessions led by trained ostomy nurses and peer ostomates

16 weeks

2 telephone sessions, 5 telehealth sessions

Follow-up

Participants are monitored for psychological distress, quality of life, and self-efficacy for ostomy self-management

26 weeks

Assessments at 13 and 26 weeks post-randomization

What Are the Treatments Tested in This Trial?

Interventions

• Telehealth Intervention for Ostomy Self-Management

Trial Overview 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.

How Is the Trial Designed?

Group I: Standard of Care Arm Experimental Treatment 1 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 Arm Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

Patients with cancer who received telenursing support after discharge for ostomy care reported higher satisfaction compared to those receiving traditional home health services, indicating that telenursing enhances patient experience.

While both care methods had similar overall costs, the telenursing group required fewer home health visits and used fewer supplies, suggesting that telenursing can be a more efficient option for managing ostomy care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traditional versus telenursing outpatient management of patients with cancer with new ostomies. Bohnenkamp, SK., McDonald, P., Lopez, AM., et al.[2007]

The Ostomy Self-Management Telehealth program (OSMT) showed potential benefits for cancer survivors with urinary tumors, particularly for those who attended more sessions, indicating that engagement in the program may enhance self-efficacy and quality of life.

While the overall results did not show significant improvements compared to usual care, higher attendance at OSMT sessions was linked to better outcomes in self-efficacy, quality of life, and reduced anxiety, suggesting that participation level may influence the effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized prospective trial of an ostomy telehealth intervention for cancer survivors. Krouse, RS., Zhang, S., Wendel, CS., et al.[2023]

The Ostomy Self-management Training (OSMT) program is a three-year randomized trial designed to improve health-related quality of life (HRQOL) for cancer survivors with ostomies by enhancing their self-efficacy and activation through telehealth sessions led by trained nurses and peer support.

By integrating goal-setting and problem-solving strategies, the OSMT program aims to address the physical, psychological, social, and spiritual needs of participants, potentially leading to better post-operative care and support for both survivors and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ostomy telehealth for cancer survivors: Design of the Ostomy Self-management Training (OSMT) randomized trial. Sun, V., Ercolano, E., McCorkle, R., et al.[2023]

The PRISMS eHealth program was found to be feasible and acceptable for cancer patients with new ostomies, with a high recruitment rate of 86.21% and a retention rate of 73.91% over a 60-day intervention period.

Patients using PRISMS reported improvements in physical and emotional well-being, while caregivers experienced a significant reduction in caregiver burden, suggesting that this intervention could enhance health outcomes during post-surgery care transitions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial. Xu, S., Tan, X., Ma, C., et al.[2023]

A self-management program delivered through a multimedia messaging app significantly improved self-efficacy and self-management abilities in rectal cancer survivors with colostomies, compared to standard care.

Participants in the self-management program experienced a lower incidence of peristomal complications, indicating that this approach may enhance patient outcomes post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Self-Management Program for Patients With Colorectal Cancer and a Colostomy: A Nonrandomized Clinical Trial. Song, QF., Yin, G., Guo, X., et al.[2021]

A study involving 138 patients undergoing ostomy surgery found that preoperative education did not reduce the length of hospital stay compared to postoperative education, with average stays being similar (12.32 days vs 12.76 days).

However, patients who received preoperative education experienced significantly higher rates of overall complications, mortality, and readmissions, suggesting that this approach may not be as beneficial as previously thought.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Preoperative Educational Intervention for Patients Undergoing Fecal Ostomy Surgery: A Comparison Cohort Study. García-Cabrera, AM., de la Portilla de Juan, F., Navarro-Morales, L., et al.[2023]

A survey of 177 long-term rectal cancer survivors revealed that 63% reported facing at least one challenge related to ostomy self-care, with common issues including leakage and frequent pouch changes.

Younger age and higher body mass index (BMI) were linked to increased self-care challenges, indicating that targeted support may be necessary for these groups to improve their ostomy management and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ongoing ostomy self-care challenges of long-term rectal cancer survivors. Bulkley, JE., McMullen, CK., Grant, M., et al.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Traditional versus telenursing outpatient management of patients with cancer with new ostomies. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized prospective trial of an ostomy telehealth intervention for cancer survivors. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Ostomy telehealth for cancer survivors: Design of the Ostomy Self-management Training (OSMT) randomized trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of a Self-Management Program for Patients With Colorectal Cancer and a Colostomy: A Nonrandomized Clinical Trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Influence of Preoperative Educational Intervention for Patients Undergoing Fecal Ostomy Surgery: A Comparison Cohort Study. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Ongoing ostomy self-care challenges of long-term rectal cancer survivors. [2019]