Palliative Care Teaching Sessions for Family Caregivers of Patients With Non-Small Cell Lung Cancer
NCT ID: NCT00827333
Last Updated: 2016-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
372 participants
INTERVENTIONAL
2009-09-30
2014-09-30
Brief Summary
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PURPOSE: This clinical trial is studying the effects of palliative care teaching sessions in family caregivers of patients with non-small cell lung cancer.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Phase I-Usual Care
No interventions assigned to this group
Phase 2 - Intervention
educational intervention
Family Caregiver Palliative Care Intervention at weeks 7, 8, 10, and 12 post study enrollment
questionnaire administration
Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
end-of-life treatment/management
Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
psychosocial assessment and care
Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
quality-of-life assessment
Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
Interventions
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educational intervention
Family Caregiver Palliative Care Intervention at weeks 7, 8, 10, and 12 post study enrollment
questionnaire administration
Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
end-of-life treatment/management
Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
psychosocial assessment and care
Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
quality-of-life assessment
Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
Eligibility Criteria
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Inclusion Criteria
* Patients having been accrued to project 1 or project 2
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Betty Ferrell, PhD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Comprehensive Cancer Center
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Countries
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Other Identifiers
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CHNMC-08036
Identifier Type: -
Identifier Source: secondary_id
CDR0000631261
Identifier Type: REGISTRY
Identifier Source: secondary_id
08036
Identifier Type: -
Identifier Source: org_study_id
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