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

City of Hope

Status: Completed

Conditions: Stage III Bladder Cancer; Stage IIIA Colon Cancer; Stage IV Gastric Cancer; Ureter Cancer; Stage IV Renal Cell Cancer; Recurrent Ovarian Germ Cell Tumor; Recurrent Cervical Cancer; Localized Transitional Cell Cancer of the Renal Pelvis and Ureter; Stage IIIB Ovarian Epithelial Cancer; Stage IIA Rectal Cancer; Stage IIIA Gastric Cancer; Stage IIIA Ovarian Epithelial Cancer; Stage II Renal Cell Cancer; Stage IIA Lung Carcinoma; Stage IVB Uterine Sarcoma; Stage IIIC Ovarian Germ Cell Tumor; Stage IIIB Rectal Cancer; Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter; Stage IIIC Rectal Cancer; Recurrent Uterine Sarcoma; Stage IIC Ovarian Epithelial Cancer; Stage IIA Cervical Cancer; Stage II Urethral Cancer; Stage IIB Gastric Cancer; Recurrent Pancreatic Cancer; Stage III Renal Cell Cancer; Stage IIIA Ovarian Germ Cell Tumor; Stage III Pancreatic Cancer; Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter; Stage IIIB Gastric Cancer; Stage IIIB Colon Cancer; Recurrent Ovarian Epithelial Cancer; Stage IIA Ovarian Germ Cell Tumor; Regional Transitional Cell Cancer of the Renal Pelvis and Ureter; Stage IVB Cervical Cancer; Stage IIIA Uterine Sarcoma; Stage IIB Lung Carcinoma; Stage III Urethral Cancer; Stage IIIA Lung Carcinoma; Stage IIA Uterine Sarcoma; Stage IVB Rectal Cancer; Recurrent Bladder Cancer; Stage IV Bladder Cancer; Stage IIIA Cervical Cancer; Recurrent Rectal Cancer; Stage IIA Ovarian Epithelial Cancer; Stage IIB Ovarian Germ Cell Tumor; Healthy Subject; Stage IIB Colon Cancer; Stage IVA Rectal Cancer; Stage IIA Pancreatic Cancer; Stage IIC Colon Cancer; Stage IV Ovarian Epithelial Cancer; Stage IIB Ovarian Epithelial Cancer; Stage IIC Rectal Cancer; Stage IIIC Gastric Cancer; Stage IIB Uterine Sarcoma; Stage IIIC Ovarian Epithelial Cancer; Recurrent Renal Cell Cancer; Recurrent Gastric Cancer; Stage IIB Cervical Cancer; Recurrent Urethral Cancer; Stage IVA Cervical Cancer; Stage IIA Gastric Cancer; Stage IVB Colon Cancer; Recurrent Colon Cancer; Stage IIIC Uterine Sarcoma; Stage IIIB Cervical Cancer; Stage IIA Colon Cancer; Stage IV Urethral Cancer; Stage IV Pancreatic Cancer; Stage IIIC Colon Cancer; Stage IV Ovarian Germ Cell Tumor; Stage IIIB Uterine Sarcoma; Stage IIB Rectal Cancer; Stage IIB Pancreatic Cancer; Stage IVA Uterine Sarcoma; Stage II Bladder Cancer; Stage IIC Ovarian Germ Cell Tumor; Psychosocial Effects of Cancer and Its Treatment; Stage IVA Colon Cancer; Stage IIIA Rectal Cancer; Stage IIIB Lung Carcinoma; Stage IIIB Ovarian Germ Cell Tumor

Treatments: Other: questionnaire administration; Other: educational intervention; Procedure: quality-of-life assessment; Behavioral: telephone-based intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01846520

NCI-2013-00839 (Registry Identifier)

08176

Details and patient eligibility

About

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 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Arm I (FCPCI)

Experimental group

Description:

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.

Treatment:

Procedure: quality-of-life assessment

Other: educational intervention

Behavioral: telephone-based intervention

Other: questionnaire administration

Arm II (usual care)

No Intervention group

Description:

Participants receive usual care.