A Randomized Trial of a Family Palliative Care Intervention
18 Years
N/A
Both
Healthy, no Evidence of Disease, 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
Trial Information
A Randomized Trial of a Family Palliative Care Intervention
PRIMARY OBJECTIVES:
I. Test the effects of the Family Caregiver Palliative Care Intervention (FCPCI) on family
caregivers of patients with gastrointestinal, gynecologic, and urologic 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, and urologic cancers in the experimental group on quality of life (QOL) and
psychological distress as compared to family caregivers in the control group.
III. Describe family caregivers' self-care behavior, comparing the experimental and control
groups.
IV. Describe family caregivers' resource use, comparing the experimental and control groups.
V. Identify subgroups of family caregivers who benefit most from the FCPCI in rational to
sociodemographic, health status, and patient characteristics.
VI. Describe family caregivers' satisfaction with the FCPCI. VII. 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.
Inclusion Criteria:
- Primary family caregivers of cancer patients with gastrointestinal (colorectal,
pancreatic, gastric), gynecologic, or urinary cancers who are entering the City of
Hope for treatment or follow-up
- Primary family caregivers of cancer patients whoa re 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
Effects of FCPCI on caregiver burden
Outcome Description:
Analysis of covariance (ANCOVA) will be used to test group differences. Caregiver burden subscales may be tested using multivariate ANCOVA (MANCOVA).
Outcome Time Frame:
Up to 6 months
Safety Issue:
No
Principal Investigator
Betty Ferrell
Investigator Role:
Principal Investigator
Investigator Affiliation:
City of Hope Medical Center
Authority:
United States: Federal Government
Study ID:
08176
NCT ID:
NCT01846520
Start Date:
July 2013
Completion Date:
Related Keywords:
- Healthy, no Evidence of Disease
- 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
- Urinary Bladder Neoplasms
- Colonic Neoplasms
- Rectal Neoplasms
- Carcinoma, Renal Cell
- Uterine Cervical Neoplasms
- Stomach Neoplasms
- Pancreatic Neoplasms
- Ureteral Neoplasms
- Urethral Neoplasms
- Neoplasms, Germ Cell and Embryonal
- Carcinoma, Transitional Cell
- Kidney Neoplasms
- Germinoma
- Ovarian Neoplasms
- Neoplasms, Glandular and Epithelial
- Sarcoma
Name | Location |
|---|---|
| City of Hope Medical Center | Duarte, California 91010 |
