Acceptance-Based Treatment for Prostate Cancer Distress

Study Overview
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Brief Summary
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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.

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

Conditions
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Early Stage Prostate Cancer

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acceptance and Commitment Therapy<br>Group-based behavioral workshop to address cancer-related distress | Behavioral: Acceptance and Commitment Therapy<br>* group-based behavioral workshop to address cancer-related distress<br>|
| No Intervention: treatment as usual<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of dropouts | 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. | 6 months | 
| Number of refusals | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, behavioral, acceptance and commitment therapy, distress