Palliative Care Teaching Sessions for Family Caregivers of Patients With Non-Small Cell Lung Cancer
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational intervention
questionnaire administration
end-of-life treatment/management
psychosocial assessment and care
quality-of-life assessment
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Cancer focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- The primary family caregiver as identified by a patient with early or late stage non-small cell lung cancer (NSCLC) participating in Project 1 and 2
- Patients having been accrued to project 1 or project 2
Sites / Locations
- City of Hope Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Phase I-Usual Care
Phase 2 - Intervention
Arm Description
Outcomes
Primary Outcome Measures
Caregiver burden
Caregiver skills preparedness
Caregiver quality of life
Caregiver psychological distress
Caregiver self-care behavior
Resource use by caregiver
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00827333
First Posted
January 21, 2009
Last Updated
July 29, 2016
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00827333
Brief Title
Palliative Care Teaching Sessions for Family Caregivers of Patients With Non-Small Cell Lung Cancer
Official Title
Palliative Care for Quality of Life and Symptom Concerns in Family Caregivers of Lung Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
OBJECTIVES:
I. Test the effects of a family caregiver palliative care intervention (FCPCI) for informal caregivers of patients with early and late stage lung cancer on caregiver burden and caregiver skills preparedness as compared to a group of family caregivers (FC) in a usual care situation.
II. Test the effects of a FCPCI for informal caregivers of patients with early and late stage lung cancer on FC in a usual care situation.
III. Describe early and late stage FC self care behavior, comparing the usual care and FCPCI groups.
IV. Describe resource use by early and late stage FC comparing the usual care and FCPCI groups. V. Identify subgroups of FC who benefit most from the FCPCI in relation to sociodemographic characteristics, clinical/functional factors.
V. Identify subgroups of FC who benefit most from the FCPCI in relation to sociodemographic characteristics, clinical/functional factors.
OUTLINE: Family caregivers (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.
After completion of the educational intervention, a sample of FC undergo 1-hour educational interviews exploring their perspective and insights on their experience as a caregiver.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
372 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase I-Usual Care
Arm Type
No Intervention
Arm Title
Phase 2 - Intervention
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
educational intervention
Intervention Description
Family Caregiver Palliative Care Intervention at weeks 7, 8, 10, and 12 post study enrollment
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
Intervention Type
Procedure
Intervention Name(s)
end-of-life treatment/management
Intervention Description
Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Intervention Description
Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Intervention Description
Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
Primary Outcome Measure Information:
Title
Caregiver burden
Time Frame
24 weeks post study enrollment
Title
Caregiver skills preparedness
Time Frame
24 weeks post study enrollment
Title
Caregiver quality of life
Time Frame
24 weeks post study enrollment
Title
Caregiver psychological distress
Time Frame
24 weeks post study enrollment
Title
Caregiver self-care behavior
Time Frame
24 weeks post study enrollment
Title
Resource use by caregiver
Time Frame
24 weeks post study enrollment
Title
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
Time Frame
24 weeks post study enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The primary family caregiver as identified by a patient with early or late stage non-small cell lung cancer (NSCLC) participating in Project 1 and 2
Patients having been accrued to project 1 or project 2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betty Ferrell, PhD
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Palliative Care Teaching Sessions for Family Caregivers of Patients With Non-Small Cell Lung Cancer
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