Prostate Cancer: Family Care for Patients and Spouses

Study Overview
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Brief Summary
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The purpose of this study is to determine if a family-based intervention (The FOCUS Program) can improve the long-term quality of life and other psycho-social outcomes of men with prostate cancer and their spouses.

Detailed Description
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The purpose of this study was to determine if a family-based intervention (The FOCUS Program) could improve the long-term quality of life and other psycho-social outcomes of men with prostate cancer and their spouse/partners. Aim 1. The first aim was to determine if the family intervention could improve several proximal clinical outcomes (less negative appraisal of illness or caregiving, less uncertainty, less hopelessness, better family communication, higher self-efficacy, and more problem-focused coping) and improve the distal clinical outcome, quality of life, in a culturally and economically diverse sample of men with prostate cancer and their spouses. Aim 2. The second aim was to test a stress-coping model designed to predict which prostate cancer patients and their spouses are at higher risk of poorer long-term quality of life.

Official Title
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Prostate Cancer: Family Care for Patients and Spouses

Conditions
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Prostate Cancer, Quality of Life, Cancer Survivorship

Intervention / Treatment
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* Behavioral: FOCUS Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of prostate cancer Willing spousal partner Speaks and understands English Mentally and physically able to participate Minimum life expectancy of 12 months Lives within 70 miles Exclusion Criteria: Multiple primary cancers Watchful waiting status Spouse with cancer diagnosis in previous year

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FOCUS Intervention<br>Dyads randomized to this arm received the FOCUS Program, 3 home visits and 2 phone calls by trained nurses. | Behavioral: FOCUS Program<br>* Supportive, educative sessions with patients and spouses.<br>* Other names: Family-based intervention;|
| No Intervention: Standard Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | Baseline, 4, 8 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Threat appraisal |  | Baseline, 4, 8 and 12 months | 
| Uncertainty |  | Baseline, 4, 8 and 12 months | 
| Hopelessness |  | Baseline, 4, 8 and 12 months | 
| Coping |  | Baseline, 4, 8 and 12 months | 
| Family Communication |  | Baseline, 4, 8 and 12 months | 
| Self-Efficacy |  | Baseline, 4, 8 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized clinical trial, coping, quality of life, family, family caregiver, cancer survivorship, communication, uncertainty, support, family education, Caregivers