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OpenTrials
Completed

NCT Number: NCT01594593

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.

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Key information

Conditions

Early Stage Prostate Cancer Behavior Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System

San Diego, California, 92161, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acceptance and Commitment Therapy

Behavioral

group-based behavioral workshop to address cancer-related distress

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Veterans Medical Research Foundation

Other

Collaborators

  • Alliant International University
  • University of California, San Diego

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 9, 2012
Registry last updated
Nov 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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