NCT00589966

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started May 2007

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

May 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2007

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 10, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

March 1, 2013

Status Verified

February 1, 2013

Enrollment Period

2.9 years

First QC Date

December 31, 2007

Last Update Submit

February 28, 2013

Conditions

Prostate Cancer

Keywords

prostate cancer treatmenttreatment side-effectsearly diagnosisAfrican American Mencoping skills trainingquality of lifeProstate cancer treatment side-effects

Outcome Measures

Primary Outcomes (1)

  • Symptom distress

    pretreatment, posttreatment, 3 mo followup

Secondary Outcomes (3)

  • Emotional functioning

    pretreatment, posttreatment, 3 mo followup

  • Physical functioning

    pretreatment, posttreatment, 3 mo followup

  • Self-efficacy for symptom management

    pretreatment, posttreatment, 3 mo followup

Study Arms (2)

Coping Skills Training

EXPERIMENTAL
Behavioral: Coping Skills Training

Prostate Cancer Education

ACTIVE COMPARATOR
Behavioral: Prostate Cancer Education

Interventions

Coping Skills TrainingBEHAVIORAL

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.

Coping Skills Training
Prostate Cancer EducationBEHAVIORAL

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.

Prostate Cancer Education

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27704, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsDisease

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Francis J Keefe, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

  • Lisa C Campbell, Ph.D.

    Duke University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2007

First Posted

January 10, 2008

Study Start

May 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

March 1, 2013

Record last verified: 2013-02

Locations

US(1)