Psychosocial Effects of Cancer and Its Treatment Clinical Trial
Official title:
A Randomized Trial of a Family Caregiver Palliative Care Intervention
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.
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
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