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Recovery Support for Bladder Cancer

N/A

Recruiting

Led By Michael Diefenbach, PhD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

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

Must have

Did not need or completed neo-adjuvant chemotherapy

Undergoing bladder removal surgery and one of the following urinary diversions: 1) ileal conduit, 2) neobladder or 3) Indiana pouch

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will develop and evaluate a multi-stage intervention to help patients and caregivers prepare for surgery and recovery for those with bladder cancer.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial focuses on educational support rather than medication, traditional side effects like those seen with drugs are not expected. However, participants may experience varying levels of emotional or psychological impact due to the nature of the information and support provided.

Eligibility Criteria

Inclusion Criteria

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

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I did not need or have completed chemotherapy before surgery.

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

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I can easily communicate in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Quality of Life Caregiver: The Caregiver Quality of Life Index-C

Urinary Bladder

Secondary outcome measures

Infection rate (biological factor)

Visiting Nurse/ER visits

Other outcome measures

Exploratory Cost Analysis

Trial Design

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor

458 Previous Clinical Trials

470,695 Total Patients Enrolled

1 Trials studying Patient Engagement

167 Patients Enrolled for Patient Engagement

Fox Chase Cancer CenterOTHER

227 Previous Clinical Trials

37,271 Total Patients Enrolled

Michael Diefenbach, PhDPrincipal Investigator - Northwell Health

Northwell Health

1 Previous Clinical Trials

138 Total Patients Enrolled

Media Library

Cancer Resource Information Support (CRIS) Clinical Trial Eligibility Overview. Trial Name: NCT04055311 — N/A

Patient Engagement Research Study Groups: Usual care enhanced, Intervention

Patient Engagement Clinical Trial 2023: Cancer Resource Information Support (CRIS) Highlights & Side Effects. Trial Name: NCT04055311 — N/A

Cancer Resource Information Support (CRIS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04055311 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there spots still available for volunteers to participate in this investigation?

"The current status of this research study, as per clinicaltrials.gov, is actively seeking participants; the initial posting being on October 1st 2018 and last amended on December 9th 2021."

Answered by AI

How many participants is the upper limit for this research endeavor?

"Affirmative, the information on clinicaltrials.gov demonstrates that this medical trial is actively seeking participants. The first posting was made on October 1st 2018 and revised as recently as December 9th 2021. 238 individuals need to be enrolled across 2 sites for the study's completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Recovery Support for Bladder Cancer Patients and Caregivers

Michael Diefenbach 2018. "Recovery Support for Bladder Cancer Patients and Caregivers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04055311.

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