Palliative Care Teaching Sessions for Family Caregivers of Patients With Non-Small Cell Lung Cancer

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Other: educational intervention; Other: questionnaire administration; Procedure: end-of-life treatment/management; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment

• Registration Number: NCT00827333
• Lead Sponsor: City of Hope Medical Center

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.

Study Timeline

• Study First Submitted: 2009-01-21
• Study First Submitted QC: 2009-01-21
• Study First Posted: 2009-01-22
• Study Start: 2009-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-29
• Last Update Posted: 2016-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 372

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 2 - Intervention	questionnaire administration	-
Phase 2 - Intervention	quality-of-life assessment	-
Phase 2 - Intervention	educational intervention	-
Phase 2 - Intervention	end-of-life treatment/management	-
Phase 2 - Intervention	psychosocial assessment and care	-

Primary Outcome Measures

Name	Time	Method
Caregiver psychological distress	24 weeks post study enrollment
Caregiver self-care behavior	24 weeks post study enrollment
Resource use by caregiver	24 weeks post study enrollment
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	24 weeks post study enrollment
Caregiver burden	24 weeks post study enrollment
Caregiver skills preparedness	24 weeks post study enrollment
Caregiver quality of life	24 weeks post study enrollment

Trial Locations

Locations (1)

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States