Randomized Clinical Trial of an Online Multimedia Program to Boost Coping & Function for Prostate Cancer Survivors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Fox Chase Cancer Center
- Enrollment
- 431
- Locations
- 3
- Primary Endpoint
- Adaptive Coping
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Adaptive Coping
Time Frame: Change in coping from baseline to six months
Adaptive coping was measured with the Cancer Coping Questionnaire. The total score from the Cancer Coping Questionnaire is a mean scale. There were a total of 14 items, each with a Likert-type 4-point scale, with 1 being the minimum value and 4 being the maximum value. A higher score indicated greater coping ability (i.e., better outcome).
Secondary Outcomes
- Interpersonal Concerns - Marital Interactions(Change from baseline to six months)
- Physical Functioning - Urinary Incontinence(Change from baseline to six months)
- Physical Functioning - Urinary Irritation(Change from baseline to six months)
- Physical Functioning - Bowel(Change from baseline to six months)
- Interpersonal Concerns - Medical Interactions(Change from baseline to six months)
- Physical Functioning - Sexual Functioning(Change from baseline to six months)