Trial of an Online Multimedia Program to Boost Coping & Function for Prostate Cancer Survivors (PROGRESS)
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

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.
    

Intervention name(s): PROGRESS
Intervention type(s): Behavioral
Intervention description(s): PROGRESS is a multimedia website designed to help prostate cancer survivors.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care