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

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City of Hope

Status

Completed

Conditions

Lung Cancer

Treatments

Procedure: end-of-life treatment/management
Procedure: quality-of-life assessment
Other: educational intervention
Other: questionnaire administration
Procedure: psychosocial assessment and care

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00827333
CDR0000631261 (Registry Identifier)
08036
P30CA033572 (U.S. NIH Grant/Contract)
CHNMC-08036
P01CA136396 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

372 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

372 participants in 2 patient groups

Phase I-Usual Care
No Intervention group
Phase 2 - Intervention
Active Comparator group
Treatment:
Other: questionnaire administration
Other: educational intervention
Procedure: psychosocial assessment and care
Procedure: end-of-life treatment/management
Procedure: quality-of-life assessment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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