Skip to main content
An official website of the United States government
Grant Details

Grant Number: 5R01CA224918-06 Interpret this number
Primary Investigator: Diefenbach, Michael
Organization: Feinstein Institute For Medical Research
Project Title: Recovery Support for Bladder CA Patients and Caregivers: a Multimodal Approach
Fiscal Year: 2023


ABSTRACT Treatment for muscle invasive bladder cancer (MIBC) 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 our 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. We 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, we propose to further refine our 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 that incorporates standard of care discharge instructions and modules focusing on wellness. 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. We 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. We 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 MIBC.


Feasibility and Acceptability of an Online Oncologist Training to Optimize Oncologist-Patient Communication and Value-Concordant Care in Advanced Cancer.
Authors: George L.S. , Saraiya B. , Trevino K.M. , Pflueger K. , Voelbel S. , Tagai E.K. , Miller S.M. , Epstein A.S. , Duberstein P. .
Source: Journal of palliative medicine, 2023 Oct; 26(10), p. 1386-1390.
EPub date: 2023-07-17.
PMID: 37459165
Related Citations

How should decision aids be developed, and which patient outcomes should be assessed?
Authors: Diefenbach M.A. , Miller S.M. .
Source: Cancer, 2022-08-01; 128(15), p. 2988-2989.
EPub date: 2022-05-04.
PMID: 35507272
Related Citations

Development of a text message-based intervention for follow-up colposcopy among predominately underserved Black and Hispanic/Latinx women.
Authors: Sansoni M. , Tagai E.K. , Lapitan E. , Wen K.Y. , Xu J. , Belfiglio A. , Hudson S.V. , Kohler R.E. , Hernandez E. , Miller S.M. .
Source: Cancer causes & control : CCC, 2022 Jun; 33(6), p. 861-873.
EPub date: 2022-03-25.
PMID: 35334016
Related Citations

Patient Factors and Hospital Outcomes Associated With Atypical Presentation in Hospitalized Older Adults With COVID-19 During the First Surge of the Pandemic.
Authors: Marziliano A. , Burns E. , Chauhan L. , Liu Y. , Makhnevich A. , Zhang M. , Carney M.T. , Dbeis Y. , Lindvall C. , Qiu M. , et al. .
Source: The journals of gerontology. Series A, Biological sciences and medical sciences, 2022-04-01; 77(4), p. e124-e132.
PMID: 34279628
Related Citations

Demographic and Psychosocial Characteristics Associated With Use of a Prostate Cancer Survivorship Website: Implications From a Multisite Randomized Controlled Trial.
Authors: Marziliano A. , Diefenbach M.A. , Hudson S.V. , Tagai E.K. , Handorf E.A. , Bator A. , Miller S.M. .
Source: Journal of medical Internet research, 2022-03-21; 24(3), p. e27890.
EPub date: 2022-03-21.
PMID: 35311678
Related Citations

Improved cancer coping from a web-based intervention for prostate cancer survivors: A randomized controlled trial.
Authors: Tagai E.K. , Miller S.M. , Hudson S.V. , Diefenbach M.A. , Handorf E. , Bator A. , Marziliano A. , Kutikov A. , Hall S.J. , Vira M. , et al. .
Source: Psycho-oncology, 2021 Sep; 30(9), p. 1466-1475.
EPub date: 2021-04-28.
PMID: 33855796
Related Citations

Patterns of alcohol use among early head and neck cancer survivors: A cross-sectional survey study using the alcohol use disorders identification test (AUDIT).
Authors: Teckie S. , Wotman M. , Marziliano A. , Orner D. , Yi J. , Mulvany C. , Ghaly M. , Parashar B. , Diefenbach M.A. .
Source: Oral oncology, 2021 Aug; 119, p. 105328.
EPub date: 2021-05-30.
PMID: 34077813
Related Citations

In-Hospital 30-Day Survival Among Young Adults With Coronavirus Disease 2019: A Cohort Study.
Authors: Richardson S. , Gitlin J. , Kozel Z. , Levy S. , Rahman H. , Hirsch J.S. , McGinn T. , Diefenbach M.A. .
Source: Open forum infectious diseases, 2021 Jun; 8(6), p. ofab233.
EPub date: 2021-05-07.
PMID: 34183983
Related Citations

Social and medical risk factors associated with supportive needs in the first year following localized prostate cancer treatment.
Authors: Tagai E.K. , Hudson S.V. , Diefenbach M.A. , Xu J. , Bator A. , Marziliano A. , Miller S.M. .
Source: Journal of cancer survivorship : research and practice, 2021 Feb; 15(1), p. 110-118.
EPub date: 2020-07-18.
PMID: 32681305
Related Citations

Management of Distress in Patients with Cancer-Are We Doing the Right Thing?
Authors: Dekker J. , Graves K.D. , Badger T.A. , Diefenbach M.A. .
Source: Annals of behavioral medicine : a publication of the Society of Behavioral Medicine, 2020-12-01; 54(12), p. 978-984.
PMID: 33416842
Related Citations

Provocative Questions in Behavioral Medicine and the Acceleration of our Science.
Authors: Diefenbach M.A. , Phillips A. , Bullock L. .
Source: Annals of behavioral medicine : a publication of the Society of Behavioral Medicine, 2020-12-01; 54(12), p. 920-923.
PMID: 33416837
Related Citations

Introduction to the special series: translating behavioral medicine research to prevent and control the spread of COVID-19.
Authors: Delamater A.M. , Miller S.M. , Bowen D.J. , Diefenbach M.A. , Tercyak K.P. .
Source: Translational behavioral medicine, 2020-10-08; 10(4), p. 817-818.
PMID: 32955096
Related Citations

COVID-19, stress, trauma, and peer support-observations from the field.
Authors: Fisher E.B. , Miller S.M. , Evans M. , Luu S.L. , Tang P.Y. , Dreyer Valovcin D. , Castellano C. .
Source: Translational behavioral medicine, 2020-08-07; 10(3), p. 503-505.
PMID: 32569372
Related Citations

Alcohol-related head and neck cancer: Summary of the literature.
Authors: Marziliano A. , Teckie S. , Diefenbach M.A. .
Source: Head & neck, 2020 Apr; 42(4), p. 732-738.
EPub date: 2019-11-27.
PMID: 31777131
Related Citations

Back to Top