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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA122704 | U.S. NIH Grant/Contract | View source | |
| ECU-08-0485 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: Survivors are stratified according to symptom severity (low vs moderate vs high) and clinical risk category (low vs moderate vs high). Survivor/partner dyads are randomized to 1 of 3 intervention arms.
All participants complete questionnaires at baseline, right after intervention (2 months), and 3 months after intervention (5 months). Survivors complete questionnaires over approximately 28 minutes to measure symptom distress/severity, depressed mood, quality of life, self-efficacy for symptom management, relationship quality, and coping strategies. Partners complete questionnaires over approximately 17 minutes to measure caregiver strain, depressed mood, partners' self-efficacy for symptom control, relationship quality, and coping strategies. At each evaluation, physicians provide ratings of illness severity, documentation of medical treatments for cancer and symptom management, and frequency of clinic visits for each survivor.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
African American prostate cancer survivor
Diagnosis of early-stage prostate cancer
Underwent radical prostatectomy as the primary treatment for prostate cancer within the past 2 years
Prior adjunctive radiotherapy secondary to surgery allowed
Intimate partner of cancer survivor
Spouse or any cohabiting intimate partner identified by the survivor
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa C Campbell, PhD | East Carolina University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leo W. Jenkins Cancer Center at ECU Medical School | Greenville | North Carolina | 27834 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D007172 | Erectile Dysfunction |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D011469 | Prostatic Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
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