Clinical trial NCT02224482: Trial of an Online Multimedia Program to Boost Coping & Function for Prostate Cancer Survivors (PROGRESS)
Official title: Randomized Clinical Trial of an Online Multimedia Program to Boost Coping & Function for Prostate Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-08-25
Enrollment: 431
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Adaptive Coping
timeFrame: Change in coping from baseline to six months
Secondary outcomes:
measure: Physical Functioning - Urinary Incontinence
timeFrame: Change from baseline to six months
measure: Physical Functioning - Urinary Irritation
timeFrame: Change from baseline to six months
measure: Physical Functioning - Bowel
timeFrame: Change from baseline to six months
measure: Physical Functioning - Sexual Functioning
timeFrame: Change from baseline to six months
measure: Interpersonal Concerns - Medical Interactions
timeFrame: Change from baseline to six months
measure: Interpersonal Concerns - Marital Interactions
timeFrame: Change from baseline to six months
Other outcomes:
Locations:
city: Somerset
country: United States
facility: Rutgers Cancer Insititute of New Jersey
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mt Sinai
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Suzanne Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marziliano A, Diefenbach MA, Hudson SV, Tagai EK, Handorf EA, Bator A, Miller SM. Demographic and Psychosocial Characteristics Associated With Use of a Prostate Cancer Survivorship Website: Implications From a Multisite Randomized Controlled Trial. J Med Internet Res. 2022 Mar 21;24(3):e27890. doi: 10.2196/27890.