Palliative Care Teaching Sessions for Family Caregivers of Patients With Non-Small Cell Lung Cancer
Palliative Care Teaching Sessions for Family Caregivers of Patients With Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
Sponsors and Collaborators: Beckman Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00827333
Purpose
RATIONALE: Palliative care teaching sessions may be more effective than standard care in improving caregiver burden, caregiver skills preparedness, quality of life, and distress in family caregivers of patients with non-small cell lung cancer.
PURPOSE: This clinical trial is studying the effects of palliative care teaching sessions in family caregivers of patients with non-small cell lung cancer.
Condition Intervention
Lung Cancer
Other: educational intervention
Other: questionnaire administration
Procedure: end-of-life treatment/management
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
MedlinePlus related topics: Cancer Caregivers Lung Cancer Palliative Care
U.S. FDA Resources
Study Type: Observational
Official Title: Palliative Care for Quality of Life and Symptom Concerns in Family Caregivers of Lung Cancer Patients
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
Caregiver burden [ Designated as safety issue: No ]
Caregiver skills preparedness [ Designated as safety issue: No ]
Caregiver quality of life [ Designated as safety issue: No ]
Caregiver psychological distress [ Designated as safety issue: No ]
Caregiver self-care behavior [ Designated as safety issue: No ]
Resource use by caregiver [ Designated as safety issue: No ]
Identification of a subgroup of caregivers who benefit most from the family caregiver palliative care intervention in relation to sociodemographic characteristics and clinical/functional factors [ Designated as safety issue: No ]
Estimated Enrollment: 533
Study Start Date: October 2008
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Detailed Description:
OBJECTIVES:
Compare the effects of a family caregiver palliative care intervention (FCPCI) vs usual care on caregiver burden and caregiver skills preparedness in family caregivers (FC) of patients with non-small cell lung cancer.
Compare the effects of a FCPCI intervention vs usual care on quality of life and psychological distress in these FC.
Compare the self-care behavior of these FC.
Compare resource use by these FC.
Identify subgroups of FC who benefit most from the FCPCI in relation to sociodemographic characteristics and clinical/functional factors.
OUTLINE: Family caregivers (FC) are stratified according to the patient's disease stage (early vs late). FC are assigned to 1 of 2 groups.
Group I: FC complete questionnaires at baseline and at 7, 12, 18, and 24 weeks to assess caregiver burden, caregiver skills preparedness, quality of life, distress, self care, and resource use.
Group II: FC undergo 4 individualized teaching sessions in weeks 7, 8, 10, and 12 that focus on caregiver burden; caregiver skills preparedness; management of patient psychological symptoms; management of FC distress; social and spiritual needs of the patient and FC; the continuing role of the FC in caring for the patient; and development of a personalized wellness plan. FC then receive 3 follow-up phone calls in weeks 16, 20, and 24 to review any questions regarding care; to assess symptom management, community resources, and support; and to review and support the wellness plan. FC also complete questionnaires as in group I.
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
DISEASE CHARACTERISTICS:
Primary family caregiver of a patient with early- or late-stage non-small cell lung cancer who is enrolled in CHNMC-08034 or CHNMC-08035
PATIENT CHARACTERISTICS:
Not specified
PRIOR CONCURRENT THERAPY:
Not specified
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827333
Locations
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Betty Ferrell, PhD 800-826-4673
Sponsors and Collaborators
Beckman Research Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Betty Ferrell, PhD Beckman Research Institute
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Responsible Party: City of Hope Comprehensive Cancer Center ( Betty Ferrell )
Study ID Numbers: CDR0000631261, CHNMC-08036
Study First Received: January 21, 2009
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00827333 [history]
Health Authority: Unspecified
Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Quality of Life
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma
Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
ClinicalTrials.gov processed this record on February 10, 2009
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