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Coping in African American Prostate Cancer Survivors (CAAPS)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coping Skills Training
Prostate Cancer Education
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring prostate cancer treatment, treatment side-effects, early diagnosis, African American Men, coping skills training, quality of life, Prostate cancer treatment side-effects

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of early stage, localized prostate cancer (T1-T3)
  • Must have received treatment within previous 2 years
  • Capable of self-care per Karnofsky Performance Status score of 60+
  • African American
  • Must have physician who can confirm treatment history

Exclusion Criteria:

  • Undergoing primary treatment 2 or more years ago
  • Having regional or metastatic prostate cancer at time of screening

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Coping Skills Training

Prostate Cancer Education

Arm Description

Outcomes

Primary Outcome Measures

Symptom distress

Secondary Outcome Measures

Emotional functioning
Physical functioning
Self-efficacy for symptom management

Full Information

First Posted
December 31, 2007
Last Updated
February 28, 2013
Sponsor
Duke University
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT00589966
Brief Title
Coping in African American Prostate Cancer Survivors
Acronym
CAAPS
Official Title
Coping Skills Training Groups to Enhance Recovery From Prostate Cancer in African American Men
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will test the effectiveness of an 8-week group intervention for African American men who have been treated for prostate cancer. The group intervention is based on 1) the cognitive-behavioral theoretical approach to improving adjustment to cancer and 2) masculinity theory as it relates to coping strengths and preferences in men. We will test the effectiveness of this coping skills intervention for improving survivors' quality of life in 4 areas: 1) distress related to sexual, urinary, and bowel symptoms; 2) self-confidence for managing symptoms; 3) overall emotional functioning; and 4) overall physical functioning. The effect of the coping skills group intervention in these 4 areas will be compared to a comparison intervention in which African American men will receive basic education about prostate cancer, but will not participate in coping skills training.
Detailed Description
African American men have higher diagnosis and death rates from prostate cancer than any other ethnic group. After treatment for prostate cancer, African American men also report slower recovery, including physical symptoms (e.g., sexual dysfunction, urinary incontinence) that can persist well beyond the immediate post-treatment period. Despite the evidence that African American men have poorer outcomes following prostate cancer treatment, very little is known about how to improve quality of life and enhance recovery in this group of survivors. This study will test the effectiveness of an 8-week group intervention for African American men who have been treated for prostate cancer. The group intervention is based on 1) the cognitive-behavioral theoretical approach to improving adjustment to cancer and 2) masculinity theory as it relates to coping strengths and preferences in men. In this group intervention African American prostate cancer survivors will be taught a variety of coping skills for managing both the physical and emotional challenges of living with prostate cancer. The coping skills training groups will consist of 6-8 survivors and will be conducted in both medical center clinic settings and community settings (e.g., churches). Each group session will be co-led by an African American psychologist and an African American male lay person. We will test the effectiveness of this coping skills intervention for improving survivors' quality of life in 4 areas: 1) distress related to sexual, urinary, and bowel symptoms; 2) self-confidence for managing symptoms; 3) overall emotional functioning; and 4) overall physical functioning. The effect of the coping skills group intervention in these 4 areas will be compared to a comparison intervention in which African American men will receive basic education about prostate cancer, but will not participate in coping skills training. The recruitment goal for this project is 154 African American men treated for early stage prostate cancer. Due to the comprehensive nature of the coping skills training intervention (i.e., a variety of coping skills targeting both physical and emotional challenges of prostate cancer), we expect coping skills training to be significantly more effective than cancer education. Ultimately, findings from this study could fill a significant gap that exists in the research literature regarding our understanding of how to help African American men achieve the fullest possible recovery following prostate cancer treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer treatment, treatment side-effects, early diagnosis, African American Men, coping skills training, quality of life, Prostate cancer treatment side-effects

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coping Skills Training
Arm Type
Experimental
Arm Title
Prostate Cancer Education
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Coping Skills Training
Intervention Description
Coping Skills Training teaches skills for managing physical, emotional, and social challenges of symptoms commonly experienced by men who have undergone treatment for early stage prostate cancer. Coping skills include activity pacing, managing negative mood, communication enhancement, and applied relaxation.
Intervention Type
Behavioral
Intervention Name(s)
Prostate Cancer Education
Intervention Description
Prostate Cancer Education provides information on the following topics: common treatment side-effects, medical options for symptom management, nutrition to support recovery, and guidelines for communicating with your healthcare team.
Primary Outcome Measure Information:
Title
Symptom distress
Time Frame
pretreatment, posttreatment, 3 mo followup
Secondary Outcome Measure Information:
Title
Emotional functioning
Time Frame
pretreatment, posttreatment, 3 mo followup
Title
Physical functioning
Time Frame
pretreatment, posttreatment, 3 mo followup
Title
Self-efficacy for symptom management
Time Frame
pretreatment, posttreatment, 3 mo followup

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of early stage, localized prostate cancer (T1-T3) Must have received treatment within previous 2 years Capable of self-care per Karnofsky Performance Status score of 60+ African American Must have physician who can confirm treatment history Exclusion Criteria: Undergoing primary treatment 2 or more years ago Having regional or metastatic prostate cancer at time of screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis J Keefe, Ph.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa C Campbell, Ph.D.
Organizational Affiliation
Duke University
Official's Role
Study Director
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States

12. IPD Sharing Statement

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Coping in African American Prostate Cancer Survivors

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