Ignite Creation Date:
2024-05-06 @ 3:12 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02224482
Status:
COMPLETED
Last Update Posted:
2021-10-12
First Post:
2014-08-21
Brief Title:
Trial of an Online Multimedia Program to Boost Coping Function for Prostate Cancer Survivors PROGRESS
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Randomized Clinical Trial of an Online Multimedia Program to Boost Coping Function for Prostate Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROGRESS
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 teams Cognitive-Social Health Information Processing Model
PROGRESS focuses on promoting adaptive coping within four key post-treatment domains 1 Physical Dysfunction eg physical symptoms 2 Emotional Well- Being eg fear of recurrence 3 Interpersonal Concerns eg sexual intimacy issues and 4 Practical Barriers eg 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 vitalityenergy 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 familyfriends marital problems and practical concerns A theory-based test of mediators of intervention effects ie self-efficacy for the survivorship phase confidence in ability to manage symptoms related to prostate cancer perceived information utility and moderators ie 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
PROGRESS focuses on promoting adaptive coping within four key post-treatment domains 1 Physical Dysfunction eg physical symptoms 2 Emotional Well- Being eg fear of recurrence 3 Interpersonal Concerns eg sexual intimacy issues and 4 Practical Barriers eg 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 vitalityenergy 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 familyfriends marital problems and practical concerns A theory-based test of mediators of intervention effects ie self-efficacy for the survivorship phase confidence in ability to manage symptoms related to prostate cancer perceived information utility and moderators ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA158019 | NIH | None | httpsreporternihgovquickSearchR01CA158019 |