Recovery Support for Bladder Cancer

No longer recruiting at 1 trial location

Overseen By Thomas Mistretta, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Temporary caregiving relationship

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist bladder cancer patients and their caregivers before and after bladder removal surgery. The study will test a new two-part program called Cancer Resource Information Support (CRIS), which includes pre-surgery education from a nurse and a special recovery website with videos and resources. Researchers will compare participants to those receiving standard care materials. The trial seeks to reduce complications and improve quality of life. It is suited for bladder cancer patients undergoing bladder removal and specific urinary diversions who can easily communicate in English. As an unphased trial, this study offers participants access to innovative resources that may enhance recovery and quality of life.

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

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

What prior data suggests that this intervention is safe for bladder cancer patients and their caregivers?

Research has shown that the Cancer Resource Information Support (CRIS) program helps bladder cancer patients and their caregivers manage life after surgery. Studies have found CRIS easy to use and beneficial for recovery from bladder cancer surgery. No negative effects have been reported from using this software. The program aims to improve quality of life by providing important information and resources. As an informational support tool, not a drug or medical device, CRIS does not carry the same safety concerns as traditional treatments. Participants have found it helpful and simple to use, making it a safe choice for supporting recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to support bladder cancer patients and their caregivers beyond the typical post-operative care. While standard care involves instructions from nursing staff and a survivorship manual, this trial introduces an internet-based software program that could revolutionize patient education. This program delivers targeted bladder cancer care instructions through engaging videos, text, and graphics, potentially enhancing understanding and adherence to care protocols. By utilizing technology to provide comprehensive and accessible resources, this approach could significantly improve patient outcomes and quality of life.

What evidence suggests that this trial's interventions could be effective for bladder cancer recovery?

Research has shown that the Cancer Resource Information Support (CRIS) program, available to participants in this trial, aims to enhance the quality of life and recovery for bladder cancer patients and their caregivers. The CRIS program provides a website featuring videos, text, and pictures to assist users in managing their health and lifestyle post-surgery. Early results suggest these resources can improve recovery and reduce issues such as infections and unexpected hospital visits. Although the program is still under evaluation, it is tailored to the specific needs of bladder cancer patients, making it a promising tool for supporting recovery. Another group in this trial will receive usual care, supplemented with standard instructions and the NCI-published Facing Forward cancer survivorship manual. ^{1 2 6 7 8}

Who Is on the Research Team?

Michael Diefenbach, PhD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for English-speaking men and women diagnosed with bladder cancer who are about to have their bladders removed and replaced with an artificial one (ileal conduit, neobladder, or Indiana pouch). They should not be in need of or already finished with neo-adjuvant chemotherapy. Caregivers must be in a stable caregiving role, not temporary.

Inclusion Criteria

I did not need or have completed chemotherapy before surgery.

I am having my bladder removed and will get a new way to pass urine.

I have been diagnosed with breast cancer.

Exclusion Criteria

My caregiver is temporarily helping me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment Preparation

In-person preparatory instructional session with a trained health care professional to equip patients and caregivers with skills for upcoming treatment and recovery

1-2 weeks

1 visit (in-person)

Post-treatment Support

Interactive web-based program providing support to enhance quality of life and reduce infections and nurse/ER visits

12 months

Follow-up

Participants are monitored for quality of life, infection rates, and nurse/ER visits

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Cancer Resource Information Support (CRIS)
• CRIS - Cancer Resource Information Support
• Usual Care Enhanced

Trial Overview The study tests a multi-stage intervention called Cancer Resource Information Support (CRIS) versus Usual Care Enhanced. CRIS includes pre-surgery preparation by nurses, stoma care training, and access to a recovery website with resources. The control group receives Facing Forward brochures from the National Cancer Institute.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Bladder cancer patients \& caregivers receive standard instructions about post-op care from nursing staff plus access to Internet based software program, specifically designed for this research study. Software program contains relevant bladder cancer care instructions through videos, text, and graphics.

Group II: Usual care enhanced Active Control 1 Intervention

Bladder cancer patients \& caregivers receive standard instructions about post-op care from nursing staff plus the NCI published Facing forward cancer survivorship manual.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Fox Chase Cancer Center

Collaborator

Trials

236

Recruited

39,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10337367/

Cancer Resource and Information Support (CRIS) for ... Objective. To improve the health-related quality of life and postsurgical outcomes of both bladder cancer survivors and their caregivers, the ...

2. urotoday.com urotoday.com/recent-abstracts/urologic-oncology/bladder-cancer/145314-cancer-resource-and-information-support-cris-for-bladder-cancer-survivors-and-their-caregivers-development-and-usability-testing-study.html

Development and Usability Testing Study. The efficacy of CRIS in improving patients' and caregivers' quality of life is currently being evaluated in a randomized controlled trial. JMIR ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37347533/

Cancer Resource and Information Support (CRIS) for Bladder ... A web-based software for survivors of bladder cancer and their caregivers to serve as a health management and lifestyle resource after surgery.

4. profiles.foxchase.org profiles.foxchase.org/en/publications/cancer-resource-and-information-support-cris-for-bladder-cancer-s

Development and Usability Testing Study Objective: To improve the health-related quality of life and postsurgical outcomes of both bladder cancer survivors and their caregivers, the ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04055311/recovery-support-for-bladder-cancer-patients-and-caregivers

Recovery Support for Bladder Cancer Patients and ... The website will be part 2 of this research and will contain important recovery information, videos about post-surgical care, testimonials by ...

6. worldbladdercancer.org worldbladdercancer.org/patient-and-carer-experiences-with-bladder-cancer/

Bladder Cancer Patient & Carer Experience Survey For all stages combined, the 5-year relative survival rate is 77% (US data). Bladder cancer is significantly more common in men, representing 75% of all cases – ...

7. researchgate.net researchgate.net/publication/371787635_Cancer_Resource_and_Information_Support_CRIS_for_Bladder_Cancer_Survivors_and_Their_Caregivers_Development_and_Usability_Testing_Study

Cancer Resource and Information Support (CRIS) for ... Objective: To improve the health-related quality of life and postsurgical outcomes of both bladder cancer survivors and their caregivers, the ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1462388922001399

Information needs in patients with bladder cancer ... This study investigated experiences of information needs in patients with bladder cancer undergoing radical cystectomy.