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

Not Applicable

Completed

• Conditions: Localized Transitional Cell Cancer of the Renal Pelvis and Ureter; Recurrent Bladder Cancer; Stage IIB Cervical Cancer; Stage IIC Ovarian Epithelial Cancer; Stage IIIA Cervical Cancer; Stage IIIA Rectal Cancer; Stage IIIB Colon Cancer; Stage IIIB Uterine Sarcoma; Stage IIIC Rectal Cancer; Stage IV Ovarian Epithelial Cancer
• Interventions: Other: educational intervention; Behavioral: telephone-based intervention; Procedure: quality-of-life assessment; Other: questionnaire administration

• Registration Number: NCT01846520
• Lead Sponsor: City of Hope Medical Center

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

Study Timeline

• Study First Submitted: 2013-05-01
• Study First Submitted QC: 2013-05-01
• Study First Posted: 2013-05-03
• Study Start: 2013-10
• Primary Completion: 2019-05-23
• Study Completion: 2019-05-23
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (FCPCI)	telephone-based intervention	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.
Arm I (FCPCI)	quality-of-life assessment	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.
Arm I (FCPCI)	educational intervention	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.
Arm I (FCPCI)	questionnaire administration	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.

Primary Outcome Measures

Name	Time	Method
Effects of FCPCI on psychological distress	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 Family Caregiver Palliative Care Intervention (FCPCI) on caregiver burden	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	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)	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 Outcome Measures

Name	Time	Method
Family caregivers' satisfaction with the FCPCI	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's self-care behavior	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.
Identification of subgroups of family caregivers who benefit most from the FCPCI in relation to sociodemographic, health status, and patient characteristics	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.
Caregiver out-of-pocket costs	Up to 6 months	A descriptive analysis of family caregivers' costs will be conducted.
Caregivers' resource use	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.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States