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Clinical Trials/NCT01594593
NCT01594593
Completed
N/A

Pilot Study of an Acceptance and Commitment Therapy Workshop for Distress and Decision Making in Early Stage Prostate Cancer in Veterans

Veterans Medical Research Foundation1 site in 1 country24 target enrollmentMarch 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Early Stage Prostate Cancer
Sponsor
Veterans Medical Research Foundation
Enrollment
24
Locations
1
Primary Endpoint
Number of dropouts
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
November 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Veterans Medical Research Foundation
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Localized prostate cancer in Stages I or II
  • Ability to give informed consent
  • Age 18 to 80 years old
  • Willingness to come in for a day long intervention

Exclusion Criteria

  • Acute psychosis
  • Suicidal ideation
  • Homicidal ideation
  • Active substance abuse

Outcomes

Primary Outcomes

Number of dropouts

Time Frame: 6 months

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

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.

Secondary Outcomes

  • Hospital Anxiety and Depression Scale(baseline, post intervention, 2 weeks post intervention, 3 months post intervention)
  • Memorial Anxiety Scale for Prostate Cancer(baseline, post intervention, 2 weeks post intervention, 3 months post intervention)

Study Sites (1)

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