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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00827333
First received: January 21, 2009
Last updated: July 10, 2014
Last verified: July 2014

January 21, 2009
July 10, 2014
October 2008
January 2015   (final data collection date for primary outcome measure)
  • 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 ]
  • Caregiver burden [ Designated as safety issue: No ]
  • Caregiver skills preparedness [ Designated as safety issue: No ]
  • Caregiver quality of life [ Designated as safety issue: No ]
  • Caregiver psychological distress [ Designated as safety issue: No ]
  • Caregiver self-care behavior [ Designated as safety issue: No ]
  • Resource use by caregiver [ 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 [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00827333 on ClinicalTrials.gov Archive Site
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Palliative Care Teaching Sessions for Family Caregivers of Patients With Non-Small Cell Lung Cancer
Palliative Care for Quality of Life and Symptom Concerns in Family Caregivers of Lung Cancer Patients

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Lung Cancer
  • 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
  • No Intervention: Phase I-Usual Care
  • Active Comparator: Phase 2 - Intervention
    Interventions:
    • Other: educational intervention
    • Other: questionnaire administration
    • Procedure: end-of-life treatment/management
    • Procedure: psychosocial assessment and care
    • Procedure: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
533
Not Provided
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00827333
08036, P01CA136396, P30CA033572, CHNMC-08036, CDR0000631261
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Betty Ferrell, PhD Beckman Research Institute
City of Hope Medical Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP