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CompletedNCT00589966CAAPSUpdated Mar 1, 2013

Coping in African American Prostate Cancer Survivors

An interventional study of Coping Skills Training and Prostate Cancer Education in Prostate Cancer, sponsored by Duke University. Completed at 1 site in United States. Open to male participants. Per ClinicalTrials.gov, last updated 2013-03-01.

Sponsored by Duke University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • prostate cancer treatment
  • treatment side-effects
  • early diagnosis
  • African American Men
  • coping skills training
  • quality of life
  • Prostate cancer treatment side-effects
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 62 is close to the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Undergoing primary treatment 2 or more years ago
  • Having regional or metastatic prostate cancer at time of screening
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Coping Skills Training

    Behavioral: Coping Skills Training

  • Active comparator
    Prostate Cancer Education

    Behavioral: Prostate Cancer Education

Interventions

  • BehavioralCoping Skills Training

    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.

  • BehavioralProstate Cancer Education

    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.

06

What researchers measure

Primary outcomes

  1. Symptom distress

    Time frame: pretreatment, posttreatment, 3 mo followup

Secondary outcomes

  1. Emotional functioning

    Time frame: pretreatment, posttreatment, 3 mo followup

  2. Physical functioning

    Time frame: pretreatment, posttreatment, 3 mo followup

  3. Self-efficacy for symptom management

    Time frame: pretreatment, posttreatment, 3 mo followup

07

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27704, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00589966
Lead sponsor
Duke University
Collaborators
United States Department of Defense
Responsible party
Sponsor
First posted
Jan 10, 2008
Start date
May 2007
Primary completion
Apr 2010
Completion
Apr 2010
Last update
Mar 1, 2013

Study contacts

Francis J Keefe, Ph.D.
principal investigator · Duke University
Lisa C Campbell, Ph.D.
study director · Duke University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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