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

Caregiver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03686007
• Other study ID #: 17238
• Secondary ID: NCI-2017-0139117
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 6, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 355
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caregiver
• Lung Neoplasms
• 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

Intervention

Other:
• Informational Intervention
Receive MSM intervention handbook
• Informational Intervention
Receive MSM intervention research nurse coaching
• Informational Intervention
Receive ASCO print materials
• Informational Intervention
Receive CRA assistance
• Media Intervention
View the MSM intervention videos
• Media Intervention
View ASCO Cancer.net videos
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in family caregiver psychological distress (as measured by the Distress Thermometer)		outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
Primary	Change in caregiving burden (as measured by the Montgomery Borgatta Caregiver Burden Scale)		outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
Primary	Change in preparedness for caregiving (as measured by the Preparedness for Caregiving Scale)		outcomes are measured before surgery (baseline), 1 day before discharge, 1 month, and 3 months post-discharge
Primary	Change in family caregiver quality of life (as measured by the City of Hope-Quality of Life-Family (COH-QOL-Family)		outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
Primary	Change in family caregiver resource use (as measured by the Family Caregiver Healthcare Use Inventory)		outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
Primary	Change in patient psychological distress (as measured by the Distress Thermometer)		outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
Primary	Change in patient quality of life (as measured by the Functional Assessment of Cancer Therapy-Lung - FACT-L)		outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
Primary	Change in patient healthcare resource use (home health nursing care, urgent/ER visits, hospital readmissions)		outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
Secondary	Change in family caregiver and patient self-efficacy (as measured by the Self-Efficacy Scale)		outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
Secondary	Change in family caregiver activation (as measured by the FCG Activation in Transitions Tool)		outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
Secondary	Change in patient activation (as measured by the Patient Activation Measure)		outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
Secondary	Change in family caregiver and patient knowledge (as measured by the Surgery-Related Knowledge Tool)		outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge