Clinical Trials Directory

Trials / Completed

CompletedNCT01846520

Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers

A Randomized Trial of a Family Caregiver Palliative Care Intervention

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
200 (estimated)
Sponsor
City of Hope Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
OTHEReducational interventionReceive FCPCI home education sessions
BEHAVIORALtelephone-based interventionReceive FCPCI telephone support sessions and 24 hour telephone support
PROCEDUREquality-of-life assessmentAncillary studies
OTHERquestionnaire administrationAncillary studies

Timeline

Start date
2013-10-01
Primary completion
2019-05-23
Completion
2019-05-23
First posted
2013-05-03
Last updated
2020-01-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01846520. Inclusion in this directory is not an endorsement.