The diagnosis of advanced, incurable cancer at different stages of the adult life span holds a variety of meanings for family members who often must play critical roles in patient care and decision-making. Family caregivers are greatly affected by the diagnosis and treatment of late-stage cancer in a loved one and may find it difficult to meet the demands of taking care of their loved one through end-of-life care and taking care of their own well-being. This grant provides funding to examine processes and outcomes of the intervention for family caregivers of advanced cancer patients.
Primary Outcome Measures:
- The primary goal of this project is to examine main effects of the intervention and patient age group interaction effects of the CCS intervention on perspectives and well-being of family caregivers during advanced cancer care and in bereavement. [ Time Frame: one year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess the efficacy of the intervention among patients in coping and decisions around end of life. [ Time Frame: two years ] [ Designated as safety issue: No ]
| Estimated Enrollment: |
556 |
| Study Start Date: |
June 2004 |
| Estimated Study Completion Date: |
November 2008 |
| Estimated Primary Completion Date: |
November 2008 (Final data collection date for primary outcome measure) |
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1: Experimental
In the intervention arm, Patients and their family caregivers have access to a coping and communication support practitioner (CCSP) (see intervention description) in addition to receiving the usual care in the site.
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Behavioral: coping and communication support (CCS) intervention
Trained clinical nurse specialists with masters degrees in mental health will serve as CCS practitioners and they will be available to patients and family caregivers on a 24/7 basis to assist with coping and communication challenges as they may arise.
The CCS intervention is tailored to individual preferences over time, and designed to accommodate different age groups, especially older adults and their families.
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2: No Intervention
In the control arm, Patients are receiving the usual care in the site.
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We are testing a coping and communication support (CCS) intervention for advanced stage cancer patients and their family caregivers over the period when goals of care may shift, i.e. beginning shortly after diagnosis. This randomized clinical trial is being conducted in two urban tertiary cancer clinics that reach patients and families in low income and diverse underserved populations: the Louis Stokes Cleveland VAMC and MetroHealth Medical Center. Recruitment and randomization are based on patient's diagnosis and age. The patient had to have been diagnosed with a stage IV cancer within a year of enrollment and they must fall into one of two age groups: middle-aged (ages 40-60); or older (61 and older). Patients are stratified by age group and then randomized to usual care or CCS intervention. Family care-givers are randomized along with the patient. Trained clinical nurse specialists with advanced training in mental health serve as CCS practitioners. They are available to patients and family caregivers on a 24/7 basis to assist with coping and communication challenges as they may arise. The primary goal of this project is to examine main effects of the intervention and patient age group interaction effects of the CCS intervention on perspectives and well-being of family caregivers during advanced cancer care and in bereavement.
Purpose
