A Randomized Trial of a Family Caregiver Palliative Care Intervention
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy Subject
- Sponsor
- City of Hope Medical Center
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Effects of Family Caregiver Palliative Care Intervention (FCPCI) on caregiver burden
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This randomized clinical trial studies the Family Caregiver Palliative Care Intervention in supporting caregivers of patients with stage II-IV gastrointestinal, gynecologic, urologic and lung cancers. Education and telephone counseling may reduce stress and improve the well-being and quality of life of caregivers of cancer patients.
Detailed Description
PRIMARY OBJECTIVES: I. Test the effects of the Family Caregiver Palliative Care Intervention (FCPCI) on family caregivers of patients with gastrointestinal, gynecologic, urologic and lung cancers in the experimental group on caregiver burden and caregiving skills preparedness as compared to family caregivers in the control group. II. Test the effects of the FCPCI on family caregivers of patients with gastrointestinal, gynecologic, urologic and lung cancers in the experimental group on quality of life (QOL) and psychological distress as compared to family caregivers in the control group. SECONDARY OBJECTIVES: I. Describe family caregivers' self-care behavior, comparing the experimental and control groups. II. Describe family caregivers' resource use, comparing the experimental and control groups. III. Identify subgroups of family caregivers who benefit most from the FCPCI in relation to sociodemographic, health status, and patient characteristics. IV. Describe family caregivers' satisfaction with the FCPCI. V. Describe caregiver out-of-pocket costs and the cost of the intervention. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants receive FCPCI with an advanced practice nurse (APN), comprising 4 home education sessions once weekly followed by 4 telephone support sessions for 30 minutes once monthly and 24 hour telephone support available for 6 months. ARM II: Participants receive usual care
Investigators
Eligibility Criteria
Inclusion Criteria
- •Primary family caregivers of cancer patients with gastrointestinal (colorectal, pancreatic, gastric), gynecologic, urinary or lung cancers who are entering the City of Hope for treatment or follow-up
- •Primary family caregivers of cancer patients who are diagnosed with stage II-IV disease
- •Primary family caregivers of cancer patients with \> 6 months prognosis
- •Living within a 50 mile radius of the City of Hope
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Effects of Family Caregiver Palliative Care Intervention (FCPCI) on caregiver burden
Time Frame: Up to 6 months
Analysis of covariance (ANCOVA) will be used to test group differences. Caregiver burden subscales may be tested using multivariate ANCOVA (MANCOVA).
Effects of FCPCI on caregiving skills preparedness
Time Frame: Up to 6 months
ANCOVA will be used to test group differences. Caregiver burden subscales may be tested using MANCOVA.
Effects of FCPCI on psychological distress
Time Frame: Up to 6 months
ANCOVA will be used to test group differences. MANCOVA may be used to test group differences of QOL subscale scores.
Effects of FCPCI on Quality Of Life (QOL)
Time Frame: Up to 6 months
ANCOVA will be used to test group differences. MANCOVA may be used to test group differences of QOL subscale scores.
Secondary Outcomes
- Caregiver's self-care behavior(Up to 6 months)
- Identification of subgroups of family caregivers who benefit most from the FCPCI in relation to sociodemographic, health status, and patient characteristics(3 months)
- Family caregivers' satisfaction with the FCPCI(6 months)
- Caregivers' resource use(Up to 6 months)
- Caregiver out-of-pocket costs(Up to 6 months)