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Clinical trial

Optimizing Veteran-Centered Prostate Cancer Survivorship Care

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Last updated:1st Apr 2015

Our study will provide much needed information about how to optimize the quality of care and quality of life of Veterans who are survivors ofprostate cancer.

Study Type: Interventional

Allocation: Randomized

Endpoint Classification: Efficacy Study

Intervention Model: Parallel Assignment

Masking: Open Label

Primary Purpose: Supportive CareOfficial Title:Optimizing Veteran-Centered Prostate Cancer Survivorship Care

Estimated Enrollment: 650

Study Start Date: April 2015

Estimated Study Completion Date: January 2018

Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

 

Arms:

Experimental: IVR Intervention
The intervention will consist of two components, both with content design based on established theories for self-management support: 1) automated telephone monitoring of PC survivor symptoms and goals for symptom reduction, based on a patient empowerment approach, and 2) personally tailored newsletters that incorporate elements of CBT to improve survivors identification with the material, confidence/self-efficacy in symptom management, and to reduce common cognitive distortions related to successful implementation of behavior change. Intervention-group participants will receive four automated assessment and self-management support calls over a 3-month period (at baseline, 1-month, 2-month, 3-months). Information collected during automated phone assessments will be used to construct tailored newsletters, which will be sent following each automated call.

No Intervention: Enhanced Usual Care
Because of the strong evidence documenting symptom burden in PC survivors, we believe that providing control subjects with some information about symptom self-management is warranted. We further believe, based on our prior experience conducting RCTs, that offering some type of educational material for Veterans randomized to the control arm will increase their willingness to enroll in the study (as opposed to a pure usual care arm where they would not receive any such materials). Therefore, survivors randomized to the control condition will receive written material at the time of enrollment designed to educate them about PC symptoms and symptom management. Material will be approximately six pages in length, also written at or below an 8th grade reading level, and will include a summary of common symptoms experienced by prostate cancer survivors.

Category Value
Study start date 2015-04-01

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