Clinical trial NCT01846520: Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
Official title: A Randomized Trial of a Family Caregiver Palliative Care Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subject
Localized Transitional Cell Cancer of the Renal Pelvis and Ureter
Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
Psychosocial Effects of Cancer and Its Treatment
Recurrent Bladder Cancer
Recurrent Cervical Cancer
Recurrent Colon Cancer
Recurrent Gastric Cancer
Recurrent Ovarian Epithelial Cancer
Recurrent Ovarian Germ Cell Tumor
Recurrent Pancreatic Cancer
Recurrent Rectal Cancer
Recurrent Renal Cell Cancer
Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
Recurrent Urethral Cancer
Recurrent Uterine Sarcoma
Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
Stage II Bladder Cancer
Stage II Renal Cell Cancer
Stage II Urethral Cancer
Stage IIA Cervical Cancer
Stage IIA Colon Cancer
Stage IIA Gastric Cancer
Stage IIA Ovarian Epithelial Cancer
Stage IIA Ovarian Germ Cell Tumor
Stage IIA Pancreatic Cancer
Stage IIA Rectal Cancer
Stage IIA Uterine Sarcoma
Stage IIB Cervical Cancer
Stage IIB Colon Cancer
Stage IIB Gastric Cancer
Stage IIB Ovarian Epithelial Cancer
Stage IIB Ovarian Germ Cell Tumor
Stage IIB Pancreatic Cancer
Stage IIB Rectal Cancer
Stage IIB Uterine Sarcoma
Stage IIC Colon Cancer
Stage IIC Ovarian Epithelial Cancer
Stage IIC Ovarian Germ Cell Tumor
Stage IIC Rectal Cancer
Stage III Bladder Cancer
Stage III Pancreatic Cancer
Stage III Renal Cell Cancer
Stage III Urethral Cancer
Stage IIIA Cervical Cancer
Stage IIIA Colon Cancer
Stage IIIA Gastric Cancer
Stage IIIA Ovarian Epithelial Cancer
Stage IIIA Ovarian Germ Cell Tumor
Stage IIIA Rectal Cancer
Stage IIIA Uterine Sarcoma
Stage IIIB Cervical Cancer
Stage IIIB Colon Cancer
Stage IIIB Gastric Cancer
Stage IIIB Ovarian Epithelial Cancer
Stage IIIB Ovarian Germ Cell Tumor
Stage IIIB Rectal Cancer
Stage IIIB Uterine Sarcoma
Stage IIIC Colon Cancer
Stage IIIC Gastric Cancer
Stage IIIC Ovarian Epithelial Cancer
Stage IIIC Ovarian Germ Cell Tumor
Stage IIIC Rectal Cancer
Stage IIIC Uterine Sarcoma
Stage IV Bladder Cancer
Stage IV Gastric Cancer
Stage IV Ovarian Epithelial Cancer
Stage IV Ovarian Germ Cell Tumor
Stage IV Pancreatic Cancer
Stage IV Renal Cell Cancer
Stage IV Urethral Cancer
Stage IVA Cervical Cancer
Stage IVA Colon Cancer
Stage IVA Rectal Cancer
Stage IVA Uterine Sarcoma
Stage IVB Cervical Cancer
Stage IVB Colon Cancer
Stage IVB Rectal Cancer
Stage IVB Uterine Sarcoma
Ureter Cancer
Stage IIA Lung Carcinoma
Stage IIB Lung Carcinoma
Stage IIIA Lung Carcinoma
Stage IIIB Lung Carcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: American Cancer Society (ACS) National Office
First posted: 2013-05-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility 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

Primary outcomes:
measure: Effects of Family Caregiver Palliative Care Intervention (FCPCI) on caregiver burden
timeFrame: Up to 6 months
measure: Effects of FCPCI on caregiving skills preparedness
timeFrame: Up to 6 months
measure: Effects of FCPCI on Quality Of Life (QOL)
timeFrame: Up to 6 months
measure: Effects of FCPCI on psychological distress
timeFrame: Up to 6 months
Secondary outcomes:
measure: Caregiver's self-care behavior
timeFrame: Up to 6 months
measure: Caregivers' resource use
timeFrame: Up to 6 months
measure: Identification of subgroups of family caregivers who benefit most from the FCPCI in relation to sociodemographic, health status, and patient characteristics
timeFrame: 3 months
measure: Family caregivers' satisfaction with the FCPCI
timeFrame: 6 months
measure: Caregiver out-of-pocket costs
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Betty Ferrell
role: PRINCIPAL_INVESTIGATOR
References: