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BRIEF TITLE: Recovery Support for Bladder Cancer Patients and Caregivers: A Multimodal Approach

Recovery Support for Bladder Cancer Patients and Caregivers: A Multimodal Approach


  • Org Study ID: 18-0400
  • Secondary ID:
  • NCT ID: NCT04055311
  • NCT Alias:
  • Sponsor: Northwell Health - Other
  • Source: Northwell Health

Brief Summary

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 three study sites.

Detailed Description


Treatment for certain types of bladder cancer (BC) involves the removal of the bladder and
construction of a new voiding system and is physically and psychologically profoundly
challenging for patients and caregivers. Based on investigators' published literature and
extensive pilot data, patients and caregivers have extensive unmet informational, social,
psychological, instrumental, and medical needs from the time of diagnosis, through treatment
and recovery which are not adequately addressed by health care professionals. Investigators
propose to address these unmet needs through the refinement and evaluation of a
comprehensive, 2-part (in-person and web-based) intervention, geared towards the patient and
caregiver. Specifically, during Aim 1, the formative phase, investigators propose to further
refine the newly developed intervention components with the help of an established
patient/caregiver advisory board. The intervention, Recovery Support for Bladder Cancer
(RSBC), consists of a pre-treatment, in-person preparatory instructional session with a
trained health care professional (Module 1) to equip patients and caregivers with the skills
to adjust to the upcoming treatment and recovery period. This is followed by a
post-treatment, interactive web-based program (Module 2) to provide further support for both
patients and caregivers to enhance quality of life (QOL) and reduce infections and nurse/ER
visits. The RSBC intervention will be evaluated in a 12-month randomized controlled trial
(Aim 2) among patients and caregiver dyads (N=330 initial; 230 final sample) against a time
and attention comparison condition (the Facing Forward brochures). Primary outcomes for both
patients and caregivers will be improved QOL, which is hypothesized to be significantly
higher among participants randomized into RSBC. Secondary outcomes will be fewer infections
and nurse-ER visits for patients randomized into RSBC. Aim 3 proposes moderator (i.e., age,
gender, surgical diversion type) and mediator (i.e., patient activation, distress) analyses
of intervention efficacy. Investigators hypothesize that RSBC will be significantly more
successful among (a) older, (b) female participants, and (c) patients with a conduit
diversion type. Elevated levels of patient activation (i.e., higher self-care knowledge,
self-efficacy, lower distress) will mediate the intervention effects. Exploratory Aim 4 will
examine the costs and potential savings associated with developing and implementing the RSBC
intervention. Investigators hypothesize that initial development and implementation costs of
RSBC will be offset by reduced nurse/ER visits. The scientific premise is strong and
supported by an established theoretical framework, extensive pilot data and a rigorous
application of clinical research methods. The proposed study is highly innovative, as it
comprehensively addresses unmet needs of both patients and caregivers from pre- and
(immediate) post-treatment to recovery. This is achieved through an innovative combination of
in-person preparation and skill-building and web-based technology. If successful, RSBC has
the potential to significantly change clinical care for patients and caregivers with BC.

Overal Status Start Date Phase Study Type
Recruiting December 5, 2019 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy

Primary Outcome 1 - Time Frame: Baseline,

Primary Outcome 2 - Measure: Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy

Primary Outcome 2 - Time Frame: 1 month

Primary Outcome 3 - Measure: Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy

Primary Outcome 3 - Time Frame: 3 months

Primary Outcome 4 - Measure: Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy

Primary Outcome 4 - Time Frame: 6 months

Primary Outcome 5 - Measure: Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy

Primary Outcome 5 - Time Frame: 12 months

Primary Outcome 6 - Measure: Quality of Life Caregiver: The Caregiver Quality of Life Index-C

Primary Outcome 6 - Time Frame: Baseline

Primary Outcome 7 - Measure: Quality of Life Caregiver: The Caregiver Quality of Life Index-C

Primary Outcome 7 - Time Frame: 1 month

Primary Outcome 8 - Measure: Quality of Life Caregiver: The Caregiver Quality of Life Index-C

Primary Outcome 8 - Time Frame: 3 months,

Primary Outcome 9 - Measure: Quality of Life Caregiver: The Caregiver Quality of Life Index-C

Primary Outcome 9 - Time Frame: 6 months,

Primary Outcome 10 - Measure: Quality of Life Caregiver: The Caregiver Quality of Life Index-C

Primary Outcome 10 - Time Frame: 12 months,

Condition:

  • Bladder Cancer
  • Patient Engagement
  • Patient Empowerment
  • Ileal Conduit

Eligibility

Criteria:
Inclusion Criteria:

- (a) male or female patients diagnosed with BC

- (b) undergoing bladder removal surgery and one of the following urinary diversions: 1)
ileal conduit, 2) neobladder or 3) Indiana pouch.

- (c) did not need or completed neo-adjuvant chemotherapy,

- (d) having a caregiver

- (e) able to communicate with ease in English

Exclusion Criteria:

- (a) the caregiving relationship is temporary (e.g., an out-of-town relative provides
temporary support) as stated by both patient and caregiver.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Michael Diefenbach, PhD

Role: Principal Investigator

Affiliation: Northwell Health

Overall Contact

Name: Michael Diefenbach, PhD

Phone: 516-600-1440

Email: mdiefenbach@northwell.edu

Locations

Facility Status Contact
Maimonides Medical Center
Brooklyn, New York 11219
United States
Recruiting Gene Sobol
718-283-3906
gsobol@maimonidesmed.org
Northwell Health
Manhasset, New York 11030
United States
Recruiting Andrea Sookchan, MPH
516-600-1439
asookchan1@northwell.edu
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Recruiting Andrew Belfiglio
215-728-7027
andrew.belfiglio@fccc.edu