Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
NCT ID: NCT01846520
Last Updated: 2020-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2013-10-31
2019-05-23
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Arm I (FCPCI)
Participants receive FCPCI with an 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.
educational intervention
Receive FCPCI home education sessions
telephone-based intervention
Receive FCPCI telephone support sessions and 24 hour telephone support
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
Arm II (usual care)
Participants receive usual care.
No interventions assigned to this group
Interventions
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educational intervention
Receive FCPCI home education sessions
telephone-based intervention
Receive FCPCI telephone support sessions and 24 hour telephone support
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
American Cancer Society (ACS) National Office
UNKNOWN
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Betty Ferrell
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Other Identifiers
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NCI-2013-00839
Identifier Type: REGISTRY
Identifier Source: secondary_id
08176
Identifier Type: -
Identifier Source: org_study_id
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