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

Overview

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.

Full Title of Study: “A Randomized Trial of a Family Caregiver Palliative Care Intervention”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: May 23, 2019

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

Interventions

  • Other: educational intervention
    • Receive FCPCI home education sessions
  • Behavioral: telephone-based intervention
    • Receive FCPCI telephone support sessions and 24 hour telephone support
  • Procedure: quality-of-life assessment
    • Ancillary studies
  • Other: questionnaire administration
    • Ancillary studies

Arms, Groups and Cohorts

  • Experimental: 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.
  • No Intervention: Arm II (usual care)
    • Participants receive usual care.

Clinical Trial Outcome Measures

Primary Measures

  • 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 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.
  • 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.

Secondary Measures

  • Caregiver’s self-care behavior
    • Time Frame: Up to 6 months
    • Qualitative analyses will be conducted on the narrative responses to the Self-Care Behaviors instrument. Self-care behaviors will be coded within each category. Results will be reviewed for consensus and validation, and any discrepancies will be resolved. Tables of coded themes with examples will be created.
  • Caregivers’ resource use
    • Time Frame: Up to 6 months
    • The qualitative analysis will be conducted on the narrative responses to the Resource Use instrument. Resources will be coded within each category. Results will be reviewed for consensus and validation, and any discrepancies will be resolved. Tables of categories and codes will be created.
  • Identification of subgroups of family caregivers who benefit most from the FCPCI in relation to sociodemographic, health status, and patient characteristics
    • Time Frame: 3 months
    • In four separate hierarchical multiple linear regression analyses, the 3 month outcome measure (caregiver burden, skills preparedness, psychological distress, and total QOL) will be regressed first on baseline measures for the relevant outcomes, followed by demographic and caregiver health status variables, and then by patient characteristics and severity of illness, using dummy-coding as appropriate.
  • Family caregivers’ satisfaction with the FCPCI
    • Time Frame: 6 months
    • A descriptive analysis of the brief satisfaction survey item results for subjects in the experimental group will be conducted, summarizing number and percent for normal data or means and standard deviations for continuous data.
  • Caregiver out-of-pocket costs
    • Time Frame: Up to 6 months
    • A descriptive analysis of family caregivers’ costs will be conducted.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • City of Hope Medical Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Betty Ferrell, Principal Investigator, City of Hope Medical Center

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