NCT03686007

Multimedia Self-Management Intervention for Lung Cancer Surgery Family Caregivers and Patients

A Multimedia Self-management Intervention to Prepare Family Caregivers and Patients for Lung Cancer Surgery

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Caregiver
• Stage I Lung Cancer AJCC v7
• Stage IA Lung Cancer AJCC v7
• Stage IB Lung Cancer AJCC v7
• Stage II Lung Cancer AJCC v7
• Stage IIA Lung Cancer AJCC v7
• Stage IIB Lung Cancer AJCC v7
• Stage III Lung Cancer AJCC v7
• Stage IIIA Lung Cancer AJCC v7
• Stage IIIB Lung Cancer AJCC v7

Interventions

Type	Name	Description
OTHER	Informational Intervention	Receive MSM intervention handbook
OTHER	Informational Intervention	Receive MSM intervention research nurse coaching
OTHER	Informational Intervention	Receive ASCO print materials
OTHER	Informational Intervention	Receive CRA assistance
OTHER	Media Intervention	View the MSM intervention videos
OTHER	Media Intervention	View American Cancer Society (ACS) videos

Timeline

• Start date: 2018-11-06
• Primary completion: 2024-08-31
• Completion: 2026-12-14
• First posted: 2018-09-26
• Last updated: 2026-02-20
• Results posted: 2025-04-27

Locations

1 site across 1 country: United States