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Acceptance-Based Treatment for Prostate Cancer Distress

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ClinicalTrials.gov Identifier: NCT01594593
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : November 19, 2012
Sponsor:
Collaborators:
Alliant International University
University of California, San Diego
Information provided by (Responsible Party):
Veterans Medical Research Foundation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Early Stage Prostate Cancer Behavioral: Acceptance and Commitment Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Hospital Anxiety and Depression Scale [ Time Frame: baseline, post intervention, 2 weeks post intervention, 3 months post intervention ]
  2. Memorial Anxiety Scale for Prostate Cancer [ Time Frame: baseline, post intervention, 2 weeks post intervention, 3 months post intervention ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  • Dementia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594593


Locations
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United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
Sponsors and Collaborators
Veterans Medical Research Foundation
Alliant International University
University of California, San Diego
Investigators
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Principal Investigator: Niloofar Afari, PhD San Diego Veterans Healthcare System
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01594593    
Other Study ID Numbers: 110353
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: November 19, 2012
Last Verified: November 2012
Keywords provided by Veterans Medical Research Foundation:
prostate cancer
behavioral
acceptance and commitment therapy
distress
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases