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2013-10
2019-05-23
2019-05-23
200
NCT01846520
City of Hope Medical Center
City of Hope Medical Center
INTERVENTIONAL
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
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.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2013-05-01 | N/A | 2020-01-21 |
2013-05-01 | N/A | 2020-01-23 |
2013-05-03 | N/A | 2020-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
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. | OTHER: educational intervention
BEHAVIORAL: telephone-based intervention
PROCEDURE: quality-of-life assessment
OTHER: questionnaire administration
|
| NO_INTERVENTION: Arm II (usual care) Participants receive usual care. |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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). | Up to 6 months |
| Effects of FCPCI on caregiving skills preparedness | 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) | 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 | 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 | Measure Description | Time Frame |
|---|---|---|
| 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. | Up to 6 months |
| 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. | 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 | 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 | 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 | A descriptive analysis of family caregivers' costs will be conducted. | Up to 6 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
