Clinical trial NCT00827333: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-01-22
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Caregiver burden
timeFrame: 24 weeks post study enrollment
measure: Caregiver skills preparedness
timeFrame: 24 weeks post study enrollment
measure: Caregiver quality of life
timeFrame: 24 weeks post study enrollment
measure: Caregiver psychological distress
timeFrame: 24 weeks post study enrollment
measure: Caregiver self-care behavior
timeFrame: 24 weeks post study enrollment
measure: Resource use by caregiver
timeFrame: 24 weeks post study enrollment
measure: 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
timeFrame: 24 weeks post study enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
Study officials:
affiliation: City of Hope Comprehensive Cancer Center
name: Betty Ferrell, PhD
role: PRINCIPAL_INVESTIGATOR
References: