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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00827333
First received: January 21, 2009
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Palliative Care for Quality of Life and Symptom Concerns in Family Caregivers of Lung Cancer Patients

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Caregiver burden [ Time Frame: 24 weeks post study enrollment ] [ Designated as safety issue: No ]
  • Caregiver skills preparedness [ Time Frame: 24 weeks post study enrollment ] [ Designated as safety issue: No ]
  • Caregiver quality of life [ Time Frame: 24 weeks post study enrollment ] [ Designated as safety issue: No ]
  • Caregiver psychological distress [ Time Frame: 24 weeks post study enrollment ] [ Designated as safety issue: No ]
  • Caregiver self-care behavior [ Time Frame: 24 weeks post study enrollment ] [ Designated as safety issue: No ]
  • Resource use by caregiver [ Time Frame: 24 weeks post study enrollment ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 24 weeks post study enrollment ] [ Designated as safety issue: No ]

Enrollment: 372
Study Start Date: September 2009
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Phase I-Usual Care
Active Comparator: Phase 2 - Intervention Other: educational intervention
Family Caregiver Palliative Care Intervention at weeks 7, 8, 10, and 12 post study enrollment
Other: 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
Procedure: psychosocial assessment and care
Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
Procedure: quality-of-life assessment
Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827333

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Betty Ferrell, PhD Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00827333     History of Changes
Other Study ID Numbers: 08036, P01CA136396, P30CA033572, CHNMC-08036, CDR0000631261
Study First Received: January 21, 2009
Last Updated: September 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014