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

City of Hope

Status: Active, not recruiting

Conditions: Stage IB Lung Cancer AJCC v7; Stage IIIA Lung Cancer AJCC v7; Stage IIIB Lung Cancer AJCC v7; Stage II Lung Cancer AJCC v7; Stage IIB Lung Cancer AJCC v7; Stage I Lung Cancer AJCC v7; Stage IIA Lung Cancer AJCC v7; Caregiver; Stage III Lung Cancer AJCC v7; Stage IA Lung Cancer AJCC v7

Treatments: Other: Media Intervention; Other: Informational Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03686007

NCI-2017-01391 (Registry Identifier)

17238

Details and patient eligibility

About

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.

Enrollment: 380 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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380 participants in 2 patient groups

Group I (MSM intervention)

Experimental group

Description:

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 via telephone(separate sessions for FCGs and patients) over 20-30 minutes at 2 and 7 days, and 2 months post-discharge.

Treatment:

Other: Informational Intervention

Other: Informational Intervention

Other: Informational Intervention

Other: Informational Intervention

Other: Media Intervention

Other: Media Intervention

Group II (Attention Control)

Active Comparator group

Description:

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 CRA approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive assistance from CRAs via telephone at 2 and 7 days, and 2 months post-discharge.

Treatment:

Other: Informational Intervention

Other: Informational Intervention

Other: Informational Intervention

Other: Informational Intervention

Other: Media Intervention

Other: Media Intervention