Acceptance-Based Treatment for Prostate Cancer Distress
Prostate cancer (PCa) is the most common type of cancer in men and the second leading cause of death in American men. Those diagnosed with localized prostate cancer encounter three sources of psychological distress: 1) diagnosis itself, 2) treatment decision making, and 3) the often life-altering side effects of treatment. In addition, patients who choose to undergo active surveillance which focuses on monitoring cancer in lieu of treatment, experience distress related to living with cancer. Acceptance and Commitment Therapy (ACT) is an established psychosocial intervention that has been used extensively for mental health treatment and has shown benefits for various chronic conditions. ACT is a behavioral intervention that focuses on tolerating distress and improving function. This pilot study is designed to test the feasibility of ACT for distress reduction and improved quality of life in patients recently diagnosed with early-stage, localized PCa.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Pilot Study of an Acceptance and Commitment Therapy Workshop for Distress and Decision Making in Early Stage Prostate Cancer in Veterans|
- Number of dropouts [ Time Frame: 6 months ] [ Designated as safety issue: No ]Because this is a pilot study to determine feasibility, one of the primary outcomes is the number of participants who drop out of the active treatment arm.
- Number of refusals [ Time Frame: 6 months ] [ Designated as safety issue: No ]Because this is a pilot study to determine feasibility, one of the primary outcomes is the number of participants who refuse the active treatment arm.
- Hospital Anxiety and Depression Scale [ Time Frame: baseline, post intervention, 2 weeks post intervention, 3 months post intervention ] [ Designated as safety issue: No ]
- Memorial Anxiety Scale for Prostate Cancer [ Time Frame: baseline, post intervention, 2 weeks post intervention, 3 months post intervention ] [ Designated as safety issue: No ]
|Study Start Date:||March 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Experimental: Acceptance and Commitment Therapy
Group-based behavioral workshop to address cancer-related distress
Behavioral: Acceptance and Commitment Therapy
group-based behavioral workshop to address cancer-related distress
|No Intervention: treatment as usual|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594593
|United States, California|
|VA San Diego Healthcare System|
|San Diego, California, United States, 92161|
|Principal Investigator:||Niloofar Afari, PhD||San Diego Veterans Healthcare System|