174 Participants Needed

Recovery Support for Bladder Cancer

Recruiting at 1 trial location
MD
AS
AY
TM
Overseen ByThomas Mistretta, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwell Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

For patients with certain types of bladder cancer, the removal of the bladder and the construction of an artificial bladder or reservoir are the only treatment options. Both before and after treatment, patients and caregivers face profound challenges preparing for surgery and planning for tasks during their recovery. To aid in recovery and enhance quality of life this program of research will develop and evaluate a multi-stage intervention geared towards patients and their caregivers. Part 1 of this program will have a nurse or trained health professional prepare both patients and their caregivers before treatment about the upcoming surgery. During this time the nurse will also demonstrate the necessary tools and techniques for stoma care. In addition, patients and their caregivers will receive access to a recovery website, specifically designed for bladder cancer patients to be used as a resource for after treatment. The website will be part 2 of this research and will contain important recovery information, videos about post-surgical care, testimonials by other patients and physicians and a variety of other resources. Patients and caregivers in the control group will receive the Facing Forward brochures from the National Cancer Institute in part 2. This research has been funded by the National Cancer Institute and will be the first study to address the needs of bladder cancer patients and their caregivers. The ultimate goal of the study is to reduce infections and unplanned nurse/ER visits and improve quality of life for both patients and their caregivers. This new program will be evaluated over the course of 12-months and if found successful, has the potential to be disseminated throughout the health care systems of the two study sites.

Research Team

MD

Michael Diefenbach, PhD

Principal Investigator

Northwell Health

Eligibility Criteria

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.
See 1 more

Exclusion Criteria

My caregiver is temporarily helping me.

Timeline

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

Treatment Details

Interventions

  • Cancer Resource Information Support (CRIS)
  • CRIS - Cancer Resource Information Support
  • Usual Care Enhanced
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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 enhancedActive Control1 Intervention
Bladder cancer patients \& caregivers receive standard instructions about post-op care from nursing staff plus the NCI published Facing forward cancer survivorship manual.

Find a Clinic Near You

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+