- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01846520
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
A Randomized Trial of a Family Caregiver Palliative Care Intervention
Study Overview
Status
Conditions
- Stage IIA Rectal Cancer
- Stage IIB Rectal Cancer
- Stage IIC Rectal Cancer
- Stage IIIA Rectal Cancer
- Stage IIIB Rectal Cancer
- Stage IIIC Rectal Cancer
- Stage III Renal Cell Cancer
- Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
- Recurrent Bladder Cancer
- Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
- Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
- Stage III Bladder Cancer
- Stage IV Bladder Cancer
- Recurrent Pancreatic Cancer
- Stage III Pancreatic Cancer
- Stage IV Pancreatic Cancer
- Ureter Cancer
- Stage IV Ovarian Epithelial Cancer
- Stage IV Ovarian Germ Cell Tumor
- Stage IV Renal Cell Cancer
- Recurrent Renal Cell Cancer
- Psychosocial Effects of Cancer and Its Treatment
- Stage IIA Pancreatic Cancer
- Stage IIB Pancreatic Cancer
- Recurrent Uterine Sarcoma
- Recurrent Ovarian Epithelial Cancer
- Stage IIIA Colon Cancer
- Stage IIIB Colon Cancer
- Stage IIIC Colon Cancer
- Stage IV Gastric Cancer
- Recurrent Colon Cancer
- Recurrent Rectal Cancer
- Recurrent Gastric Cancer
- Recurrent Ovarian Germ Cell Tumor
- Stage IVA Colon Cancer
- Stage IVA Rectal Cancer
- Stage IVB Colon Cancer
- Stage IVB Rectal Cancer
- Healthy Subject
- Stage IIA Colon Cancer
- Stage IIB Colon Cancer
- Stage IIC Colon Cancer
- Recurrent Cervical Cancer
- Stage IIA Cervical Cancer
- Stage IIB Cervical Cancer
- Stage IVA Cervical Cancer
- Stage IVB Cervical Cancer
- Stage IIIA Gastric Cancer
- Stage IIIB Gastric Cancer
- Stage IIIC Gastric Cancer
- Stage IIA Ovarian Germ Cell Tumor
- Stage IIB Ovarian Germ Cell Tumor
- Stage IIC Ovarian Germ Cell Tumor
- Stage IIIA Ovarian Germ Cell Tumor
- Stage IIIB Ovarian Germ Cell Tumor
- Stage IIIC Ovarian Germ Cell Tumor
- Recurrent Urethral Cancer
- Stage II Bladder Cancer
- Stage IIIA Ovarian Epithelial Cancer
- Stage IIIB Ovarian Epithelial Cancer
- Stage IIIC Ovarian Epithelial Cancer
- Localized Transitional Cell Cancer of the Renal Pelvis and Ureter
- Stage II Renal Cell Cancer
- Stage II Urethral Cancer
- Stage IIA Gastric Cancer
- Stage IIA Ovarian Epithelial Cancer
- Stage IIA Uterine Sarcoma
- Stage IIB Gastric Cancer
- Stage IIB Ovarian Epithelial Cancer
- Stage IIB Uterine Sarcoma
- Stage IIC Ovarian Epithelial Cancer
- Stage III Urethral Cancer
- Stage IIIA Cervical Cancer
- Stage IIIA Uterine Sarcoma
- Stage IIIB Cervical Cancer
- Stage IIIB Uterine Sarcoma
- Stage IIIC Uterine Sarcoma
- Stage IV Urethral Cancer
- Stage IVA Uterine Sarcoma
- Stage IVB Uterine Sarcoma
- Stage IIA Lung Carcinoma
- Stage IIB Lung Carcinoma
- Stage IIIA Lung Carcinoma
- Stage IIIB Lung Carcinoma
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- City of Hope Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Ancillary studies
Ancillary studies
Other Names:
Receive FCPCI home education sessions
Other Names:
Receive FCPCI telephone support sessions and 24 hour telephone support
|
No Intervention: Arm II (usual care)
Participants receive usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Up to 6 months
|
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.
|
Up to 6 months
|
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.
|
Up to 6 months
|
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.
|
Up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 6 months
|
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.
|
Up to 6 months
|
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.
|
3 months
|
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.
|
6 months
|
Caregiver out-of-pocket costs
Time Frame: Up to 6 months
|
A descriptive analysis of family caregivers' costs will be conducted.
|
Up to 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Betty Ferrell, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Respiratory Tract Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Endocrine Gland Neoplasms
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Pancreatic Diseases
- Ureteral Diseases
- Urethral Diseases
- Sarcoma
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Uterine Cervical Neoplasms
- Stomach Neoplasms
- Neoplasms, Germ Cell and Embryonal
- Lung Neoplasms
- Carcinoma
- Recurrence
- Ovarian Neoplasms
- Urinary Bladder Neoplasms
- Rectal Neoplasms
- Pancreatic Neoplasms
- Carcinoma, Ovarian Epithelial
- Colonic Neoplasms
- Carcinoma, Transitional Cell
- Ureteral Neoplasms
- Urethral Neoplasms
- Germinoma
Other Study ID Numbers
- 08176
- NCI-2013-00839 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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