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?

This trial explores a new telehealth method to help individuals manage life with an ostomy (an opening in the belly for waste removal). It targets those with bladder or colorectal cancer who are scheduled for ostomy surgery. Participants will join online group sessions to learn self-care skills from nurses and peers with ostomies. For those with bladder or colorectal cancer preparing for ostomy surgery, this trial might be suitable. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group.

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.

What prior data suggests that this telehealth intervention is safe for ostomy self-management?

Research shows that telehealth programs for ostomy care are generally safe. Studies on similar programs have found that patients handle them well. Participants in these studies did not report any serious problems from the telehealth sessions. These sessions mostly include group calls and advice from nurses and others with ostomy experience. The goal is to provide support and education to help patients manage their ostomies better. Since this trial is in an early stage, it mainly examines the usefulness and practicality of these sessions, but past studies suggest they are safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the telehealth intervention for ostomy self-management because it offers a novel approach to supporting patients with bladder and colorectal cancer, especially those who have undergone ostomy surgery. Unlike the standard of care, which primarily involves in-person clinic visits and support from institutional ostomy nurses, this telehealth intervention connects patients with peer ostomates and trained nurses through virtual sessions. This method not only enhances accessibility but also provides personalized skills-building and resources over a 16-week period, potentially improving self-management and quality of life for patients. This innovative approach could lead to more convenient and effective support for patients, reducing the need for frequent hospital visits.

What evidence suggests that this telehealth intervention is effective for ostomy self-management in bladder and colorectal cancer?

This trial will compare a Telehealth Intervention for Ostomy Self-Management with standard care. Research has shown that telehealth for ostomy self-care helps patients manage their care more effectively. Studies have found that telehealth support increases patients' confidence and readiness to manage their ostomy. In one study, participants who received telehealth assistance improved their self-care skills more than those who received regular care. Telehealth also provides consistent support and advice from trained professionals, leading to better patient outcomes. Overall, early findings suggest that telehealth is a valuable tool for individuals with an ostomy after colorectal or bladder cancer surgery. ^{1 2 3 4 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

Ability to read and understand English for Questionnaires

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

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 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]

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]

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]

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 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]

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]

Citations

1. bcan.org bcan.org/clinicaltrials/telehealth-intervention-for-ostomy-self-management/

Telehealth Intervention for Ostomy Self-Management The goal of this study is to pilot-test a perioperative ostomy self-management telehealth intervention (Periop-OSMT) in patients with colorectal and bladder ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8506262/

An Ostomy Self-management Telehealth Intervention for ... This paper examines technology-related challenges, issues, and opportunities encountered in the use of telehealth in a randomized controlled trial intervention ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714417305049

Design of the Ostomy Self-management Training (OSMT) ... This paper describes the study design of a telehealth-based Ostomy Self-management Training (OSMT) program for cancer survivors and their caregivers.

4. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35091

A randomized prospective trial of an ostomy telehealth ... This study compared the Ostomy Self-Management Telehealth program (OSMT) versus attention control usual care (UC).

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0303015

Telehealth vs in-person education for enhancing self-care of ... Adoption of telehealth technologies for ostomy patients can improve service organization by ensuring better integration and continuity of care.

6. clinconnect.io clinconnect.io/trials/NCT06528990

Telehealth Intervention for Ostomy Self-Management The goal of this study is to see how effective and practical a series of seven online group sessions can be for patients and their family caregivers, helping ...