Trial of an Online Multimedia Program to Boost Coping & Function for Prostate Cancer Survivors (PROGRESS)



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 80
Updated:2/15/2017
Start Date:February 2012
End Date:December 2017
Contact:Tanisha Belton, MPH
Email:tanisha.belton@fccc.edu
Phone:2157287027

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Randomized Clinical Trial of an Online Multimedia Program to Boost Coping & Function for Prostate Cancer Survivors

The purpose of this study is to test how well an online program designed to help prostate
cancer survivors cope with changes caused by their cancer or treatment works compared to
standard print educational materials from the National Cancer Institute (NCI).

This study involves the development and evaluation of a comprehensive and innovative
multimedia program designed to facilitate the post-treatment transition into survivorship.
The design of the intervention, the PRostate Cancer Online Guide and Resources for
Electronic Survivorship Service (PROGRESS), is theoretically based on the team's
Cognitive-Social Health Information Processing Model.

PROGRESS focuses on promoting adaptive coping within four key post-treatment domains: 1)
Physical Dysfunction (e.g., physical symptoms); 2) Emotional Well- Being (e.g., fear of
recurrence); 3) Interpersonal Concerns (e.g., sexual intimacy issues); and 4) Practical
Barriers (e.g., medical follow-up challenges). Content for these domains are organized in a
virtual resource center and will consist of: 1) provision of related information through
text, graphics, voice overs, and animation; 2) videos of health care experts answering
frequently asked questions; 3) videos of prostate cancer survivors describing their
experiences and modeling competencies and coping strategies; and 4) skills training to
improve communication between prostate cancer survivors and family and healthcare providers.
Program content has been developed through literature and evidence-based content review,
expert input, and input from multi-ethnic survivor focus groups. To ensure adequate and
appropriate program content and optimal functionality, an iterative process of review,
revision, and user and usability testing has been employed.

Intervention efficacy will be evaluated through a two-arm, prospective randomized controlled
trial. A total of 600 patients (200 from Fox Chase Cancer Center, 200 from the Cancer
Institute of New Jersey, and 200 from Icahn School of Medicine at Mount Sinai) will complete
the study. Data will be collected at baseline, and at 1-, 3- and 6- months follow-up.

The primary outcome variable will be use of adaptive coping, and secondary outcome variables
will include use of maladaptive coping, disease-specific quality of life, vitality/energy,
physical quality of life, cancer-related intrusive thoughts, emotional quality of life, fear
of recurrence, bother from physical dysfunctions, satisfaction with communication in medical
interactions, satisfaction with cancer-related with family/friends, marital problems, and
practical concerns . A theory-based test of mediators of intervention effects (i.e.,
self-efficacy for the survivorship phase, confidence in ability to manage symptoms related
to prostate cancer, perceived information utility), and moderators (i.e., demographics,
comorbid conditions, monitoring style, affect) will also be performed.

The proposed research will be the first Randomized Controlled Trial to evaluate a
comprehensive and highly disseminable and self-sustaining intervention for facilitating
post-treatment adaptation among early-stage Pca survivors. In addition, use of and
usability, accessibility, and satisfaction with PROGRESS will be assessed.

Inclusion Criteria:

- Received a diagnosis of localized disease confined to the prostate, with no regional
lymph node or distant metastasis (stages T1, T1a, T1b, T2, T2a, T2b; T2c [3]);

- Within one year completion of either radical prostatectomy or radiation
therapy(external beam radiation therapy or brachytherapy);

- Have access to a personal computer with Internet access (either in home or at a
community center);

- 18 years of age or older;

- Able to communicate in English

- Able to give consent

Exclusion Criteria:

- Unable to use a computer

- Unable to communicate in English

Exclusion Criteria:

- unable to use a computer

- unable to communicate in English
We found this trial at
3
sites
Philadelphia, Pennsylvania 19111
Principal Investigator: Suzanne Miller, PhD
Phone: 215-728-7027
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New York, New York 10029
Principal Investigator: Michael Diefenbach, PhD
Phone: 212-824-7876
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New York, NY
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Somerset, New Jersey 08873
Principal Investigator: Shawna Hudson, PhD
Phone: 732-743-3205
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Somerset, NJ
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