Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
Primary Purpose
Healthy Subject, Localized Transitional Cell Cancer of the Renal Pelvis and Ureter, Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational intervention
telephone-based intervention
quality-of-life assessment
questionnaire administration
Sponsored by
About this trial
This is an interventional supportive care trial for Healthy Subject
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
Sites / Locations
- City of Hope Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Arm I (FCPCI)
Arm II (usual care)
Arm 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.
Participants receive usual care.
Outcomes
Primary Outcome Measures
Effects of Family Caregiver Palliative Care Intervention (FCPCI) on caregiver burden
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
ANCOVA will be used to test group differences. Caregiver burden subscales may be tested using MANCOVA.
Effects of FCPCI on Quality Of Life (QOL)
ANCOVA will be used to test group differences. MANCOVA may be used to test group differences of QOL subscale scores.
Effects of FCPCI on psychological distress
ANCOVA will be used to test group differences. MANCOVA may be used to test group differences of QOL subscale scores.
Secondary Outcome Measures
Caregiver's self-care behavior
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.
Caregivers' resource use
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.
Identification of subgroups of family caregivers who benefit most from the FCPCI in relation to sociodemographic, health status, and patient characteristics
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.
Family caregivers' satisfaction with the FCPCI
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 out-of-pocket costs
A descriptive analysis of family caregivers' costs will be conducted.
Full Information
NCT ID
NCT01846520
First Posted
May 1, 2013
Last Updated
January 21, 2020
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI), American Cancer Society (ACS) National Office
1. Study Identification
Unique Protocol Identification Number
NCT01846520
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 23, 2019 (Actual)
Study Completion Date
May 23, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI), American Cancer Society (ACS) National Office
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I (FCPCI)
Arm Type
Experimental
Arm 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.
Arm Title
Arm II (usual care)
Arm Type
No Intervention
Arm Description
Participants receive usual care.
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Receive FCPCI home education sessions
Intervention Type
Behavioral
Intervention Name(s)
telephone-based intervention
Intervention Description
Receive FCPCI telephone support sessions and 24 hour telephone support
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Effects of Family Caregiver Palliative Care Intervention (FCPCI) on caregiver burden
Description
Analysis of covariance (ANCOVA) will be used to test group differences. Caregiver burden subscales may be tested using multivariate ANCOVA (MANCOVA).
Time Frame
Up to 6 months
Title
Effects of FCPCI on caregiving skills preparedness
Description
ANCOVA will be used to test group differences. Caregiver burden subscales may be tested using MANCOVA.
Time Frame
Up to 6 months
Title
Effects of FCPCI on Quality Of Life (QOL)
Description
ANCOVA will be used to test group differences. MANCOVA may be used to test group differences of QOL subscale scores.
Time Frame
Up to 6 months
Title
Effects of FCPCI on psychological distress
Description
ANCOVA will be used to test group differences. MANCOVA may be used to test group differences of QOL subscale scores.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Caregiver's self-care behavior
Description
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.
Time Frame
Up to 6 months
Title
Caregivers' resource use
Description
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.
Time Frame
Up to 6 months
Title
Identification of subgroups of family caregivers who benefit most from the FCPCI in relation to sociodemographic, health status, and patient characteristics
Description
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.
Time Frame
3 months
Title
Family caregivers' satisfaction with the FCPCI
Description
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.
Time Frame
6 months
Title
Caregiver out-of-pocket costs
Description
A descriptive analysis of family caregivers' costs will be conducted.
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betty Ferrell
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
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