Lung Cancer Clinical Trial
Multimedia Self-Management Intervention for Lung Cancer Surgery Family Caregivers and Patients
Summary
This randomized phase III trial studies how well a multimedia self-management intervention works in preparing family caregivers and patients with stage I-III lung cancer for lung cancer surgery. The multimedia self-management intervention, Preparing for your Lung Cancer Surgery, is a nurse-led, caregiver-based, multimedia intervention that may improve patient recovery after surgery, lower caregiving burden, and improve distress and quality of life.
Full Description
PRIMARY OBJECTIVES:
I. Test the effects of the multimedia self-management (MSM) intervention on family caregivers (FCG) outcomes and cancer support services use at discharge and 3-month post-discharge, comparing intervention and attention control groups.
II. Test the effects of the MSM intervention on patient outcomes and healthcare resource use at discharge and 3-months post-discharge, comparing intervention and attention control groups.
III. Test the effects of the MSM intervention on outcome mediators at discharge and 3-months post-discharge, comparing intervention and attention control groups.
SECONDARY OBJECTIVES:
I. Explore moderators (age, sex, marital status, caregiver relationship to patient, caregiver employment status, co-morbidities) of FCG and patient outcomes and reciprocal relationships.
II. Determine, through exit interviews, participant's experience with the MSM intervention.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients and FCGs receive the MSM intervention consisting of videos, a handbook, and research nurse coaching over 40-60 minutes, approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive research nurse support by telephone (separate sessions for FCGs and patients) over 20-30 minutes at 2 and 7 days, and 2 months post-discharge.
GROUP II: Patients and FCGs receive attention control intervention consisting of videos (American Cancer Society video on "Clinical Trials"), American Cancer Society print materials, and assistance from a clinical research associate (CRA) approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive assistance from CRAs via telephone calls at 2 and 7 days, and 2 months post-discharge.
Eligibility Criteria
Family Caregiver Inclusion Criteria:
A family member or friend identified by the patient as being the primary care provider before and after surgery
A patient/care recipient enrolled in the study
Age 21 years or older
Able to read or understand English
Patient Inclusion Criteria:
Diagnosis of Stage I-III non-small cell lung cancer
Scheduled to undergo surgery for treatment
A family caregiver enrolled in the study
Age 21 years or older
Able to read or understand English.
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There is 1 Location for this study
Duarte California, 91010, United States More Info
Principal Investigator
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