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

Lung Cancer Clinical Trial

Official title:

Palliative Care for Quality of Life and Symptom Concerns in Family Caregivers of Lung Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827333
• Other study ID #: 08036
• Secondary ID: P01CA136396P30CA
• Status: Completed
• Phase: N/A
• First received: January 21, 2009
• Last updated: July 29, 2016
• Start date: September 2009
• Est. completion date: September 2014

Study information

• Verified date: July 2016
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• 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

Procedure:
• 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

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caregiver burden		24 weeks post study enrollment	No
Primary	Caregiver skills preparedness		24 weeks post study enrollment	No
Primary	Caregiver quality of life		24 weeks post study enrollment	No
Primary	Caregiver psychological distress		24 weeks post study enrollment	No
Primary	Caregiver self-care behavior		24 weeks post study enrollment	No
Primary	Resource use by caregiver		24 weeks post study enrollment	No
Primary	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	No