Skip to main content
OpenTrials
Completed

NCT Number: NCT00827333

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Family Caregiver Palliative Care Intervention at weeks 7, 8, 10, and 12 post study enrollment

Questionnaire Administration

Other

Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment

end-of-life treatment/management

Procedure

Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment

psychosocial assessment and care

Procedure

Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment

quality-of-life assessment

Procedure

Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment

Primary outcomes

  1. Caregiver burden

    Time frame: 24 weeks post study enrollment

  2. Caregiver skills preparedness

    Time frame: 24 weeks post study enrollment

  3. Caregiver quality of life

    Time frame: 24 weeks post study enrollment

  4. Caregiver psychological distress

    Time frame: 24 weeks post study enrollment

  5. Caregiver self-care behavior

    Time frame: 24 weeks post study enrollment

  6. Resource use by caregiver

    Time frame: 24 weeks post study enrollment

  7. 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

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jan 22, 2009
Registry last updated
Aug 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.