Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-27 @ 2:33 PM
Study NCT ID:
NCT00589966
Status:
COMPLETED
Last Update Posted:
2013-03-01
First Post:
2007-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coping in African American Prostate Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-28', 'studyFirstSubmitDate': '2007-12-31', 'studyFirstSubmitQcDate': '2008-01-09', 'lastUpdatePostDateStruct': {'date': '2013-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom distress', 'timeFrame': 'pretreatment, posttreatment, 3 mo followup'}], 'secondaryOutcomes': [{'measure': 'Emotional functioning', 'timeFrame': 'pretreatment, posttreatment, 3 mo followup'}, {'measure': 'Physical functioning', 'timeFrame': 'pretreatment, posttreatment, 3 mo followup'}, {'measure': 'Self-efficacy for symptom management', 'timeFrame': 'pretreatment, posttreatment, 3 mo followup'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prostate cancer treatment', 'treatment side-effects', 'early diagnosis', 'African American Men', 'coping skills training', 'quality of life', 'Prostate cancer treatment side-effects'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nThis 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.\n\nDue 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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of early stage, localized prostate cancer (T1-T3)\n* Must have received treatment within previous 2 years\n* Capable of self-care per Karnofsky Performance Status score of 60+\n* African American\n* Must have physician who can confirm treatment history\n\nExclusion Criteria:\n\n* Undergoing primary treatment 2 or more years ago\n* Having regional or metastatic prostate cancer at time of screening'}, 'identificationModule': {'nctId': 'NCT00589966', 'acronym': 'CAAPS', 'briefTitle': 'Coping in African American Prostate Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Coping Skills Training Groups to Enhance Recovery From Prostate Cancer in African American Men', 'orgStudyIdInfo': {'id': 'Pro00000351'}, 'secondaryIdInfos': [{'id': 'W81XWH-07-0091'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coping Skills Training', 'interventionNames': ['Behavioral: Coping Skills Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prostate Cancer Education', 'interventionNames': ['Behavioral: Prostate Cancer Education']}], 'interventions': [{'name': 'Coping Skills Training', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Coping Skills Training']}, {'name': 'Prostate Cancer Education', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Prostate Cancer Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Francis J Keefe, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Lisa C Campbell, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}