Helping African American Prostate Cancer Survivors and Their Partners Cope With Challenges After Surgery for Prostate Cancer

NCT00869739 | Completed

• 3 other identifiers: CDR0000634536R01CA122704ECU-08-0485
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Telephone counseling after radical prostatectomy may help African American prostate cancer survivors and their intimate partners cope with the problems and challenges of surgery, and may reduce distress and improve quality of life. It is not yet known which counseling and education program is more effective in helping prostate cancer survivors and their partners. PURPOSE: This randomized clinical trial is studying effective ways to help African American prostate cancer survivors and their partners cope with challenges after surgery for early-stage prostate cancer.

Conditions

Cancer Survivor; Depression; Gastrointestinal Complications; Male Erectile Disorder; Prostate Cancer; Psychosocial Effects of Cancer and Its Treatment; Urinary Complications

Keywords

cancer survivor; depression; psychosocial effects of cancer and its treatment; male erectile disorder; urinary complications; gastrointestinal complications; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (6)

• Symptom distress in survivors as assessed by the Sexual, Urinary, and Bowel Bother subscales of the Prostate Cancer Index Composite (EPIC) (16) at baseline, 2 months, and 5 months

• Depressed mood in survivors and partners as assessed by the depression subscale of the Profile of Mood States-SF (POMS-SF, 95) at baseline, 2 months, and 5 months

• Quality of life of survivors as assessed by the Physical Well-being, Functional Well-being, and Prostate Cancer subscales of FACT-P (127) at baseline, 2 months, and 5 months

• Caregiver strain in partners as assessed by the Caregiver Strain Index (CSI) at baseline, 2 months, and 5 months

• Self-efficacy for symptom control in survivors and partners as assessed by the Self-Efficacy for Symptom Control Inventory; EPIC; and CSI at baseline, 2 months, and 5 months

• Relationship functioning in survivors and partners as assessed by the Dyadic Adjustment Scale (129) and the Miller Social Intimacy Scale (130) at baseline, 2 months, and 5 months

Secondary Outcomes (1)

• Coping skills in survivors and partners as assessed by the Coping Strategies, Social Problem Solving Scale-Revised, and La Trobe Communication Questionnaires at baseline, 2 months, and 5 months

Interventions

telephone-based intervention BEHAVIORAL

educational intervention OTHER

partner-assisted coping skills training OTHER

questionnaire administration OTHER

psychosocial assessment and care PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * African American prostate cancer survivor * Diagnosis of early-stage prostate cancer * Stage T1-T3 disease * No regional or metastatic prostate cancer * Underwent radical prostatectomy as the primary treatment for prostate cancer within the past 2 years * Prior adjunctive radiotherapy secondary to surgery allowed * No radiotherapy (i.e., external beam radiation or brachytherapy) as primary form of treatment * Intimate partner of cancer survivor * Spouse or any cohabiting intimate partner identified by the survivor * Same sex partners and partners of all ethnicities allowed PATIENT CHARACTERISTICS: * No dementia or unstable psychiatric condition * No significant hearing impairment * Fluent in English PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• East Carolina University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Leo W. Jenkins Cancer Center at ECU Medical School

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Conditions

Depression; Erectile Dysfunction; Prostatic Neoplasms

Interventions

Early Intervention, Educational; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Rehabilitation; Therapeutics

Study Officials

• Lisa C Campbell, PhD

  East Carolina University

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 26, 2009
• Study Start: August 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 25, 2013

Record last verified: 2013-02

Locations

US (1)