NCT01594593

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 9, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 19, 2012

Status Verified

November 1, 2012

Enrollment Period

1.7 years

First QC Date

April 23, 2012

Last Update Submit

November 16, 2012

Conditions

Early Stage Prostate Cancer

Keywords

prostate cancerbehavioralacceptance and commitment therapydistress

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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 Arms (2)

Acceptance and Commitment Therapy

EXPERIMENTAL

Group-based behavioral workshop to address cancer-related distress

Behavioral: Acceptance and Commitment Therapy

treatment as usual

NO INTERVENTION

Interventions

Acceptance and Commitment TherapyBEHAVIORAL

group-based behavioral workshop to address cancer-related distress

Acceptance and Commitment Therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsBehavior

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Niloofar Afari, PhD

    San Diego Veterans Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2012

First Posted

May 9, 2012

Study Start

March 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 19, 2012

Record last verified: 2012-11

Locations

US(1)