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

Not Applicable

Active, not recruiting

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

Interventions: Other: Informational Intervention
Other: Media Intervention
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

Registration Number: NCT03686007

Lead Sponsor: City of Hope Medical Center

Brief 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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 380

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.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (MSM intervention)	Informational Intervention	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.
Group I (MSM intervention)	Quality-of-Life Assessment	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.
Group I (MSM intervention)	Questionnaire Administration	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.
Group I (MSM intervention)	Media Intervention	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.
Group II (Attention Control)	Media Intervention	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.
Group II (Attention Control)	Informational Intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in Family Caregiver Psychological Distress (as Measured by the Distress Thermometer)	Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.	Mean caregiver psychological distress scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in psychological distress between the intervention and control arm over time. Score range: 0-10. Higher score means worse outcome.
Change in Caregiving Burden (as Measured by the Montgomery Borgatta Caregiver Burden Scale)	Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.	Mean caregiver burden scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in burden between the intervention and control arm over time. The model included treatment arm, time, and the interaction between treatment arm and time as effects. Total burden score is calculated by summing items from 3 subscales: objective burden, subjective burden \& demand burden. Score range: 14-70. Higher score means worse outcome.
Change in Preparedness for Caregiving (as Measured by the Preparedness for Caregiving Scale)	Outcomes are measured before surgery (baseline), 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.	Mean caregiver preparedness scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in preparedness between the intervention and control arm over time. Score range: 0-4. Higher score means better outcome.
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 month, and 3 months post-discharge. Absolute values are reported at each timeframe.	Mean caregiver QoL scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in QoL between the intervention and control arm over time. Total QoL score is calculated by summing items from 3 subscales: physical well-being, psychological well-being, social concerns \& spiritual well-being. Score range: 0-40. Higher score means better outcome.
Number of Participants Who Used Family Caregiver Resource (as Measured by the Family Caregiver Healthcare Use Inventory)	Outcomes are measured at discharge, 1 month, and 3 months post-discharge.	Differences in the number of caregivers who saw a support services specialist were compared between both groups using Chi-squared and Fisher's exact test.
Change in Patient Psychological Distress (as Measured by the Distress Thermometer)	Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.	Mean patient psychological distress scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in psychological distress between the intervention and control arm over time. Score range: 0-10. Higher score means worse outcome.
Change in Patient Quality of Life (as Measured by the Functional Assessment of Cancer Therapy-Lung - FACT-L)	Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.	Mean patient QoL scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in QoL between the intervention and control arm over time. Total FACT-L score is calculated by summing items from 5 subscales: physical well-being, social/family well-being, emotional well-being, functional well-being \& lung cancer subscale. Score range: 0-136. Higher score means better outcome.
Number of Participants Who Used Patient Healthcare Resource Use (Home Health Nursing Care, Urgent/ER Visits, Hospital Readmissions)	Outcomes are measured at 1 month, and 3 months post-discharge.	Differences in the number of patients who were readmitted to the hospital for an overnight stay were compared between both groups using Chi-squared and Fisher's exact test.

Secondary Outcome Measures

Name	Time	Method
Change in Family Caregiver Self-efficacy (as Measured by the Self-Efficacy Scale)	Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.	Mean caregiver self-efficacy scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in self-efficacy between the intervention and control arm over time. Score range: 1-4. Higher score means better outcome.
Change in Patient Self-efficacy (as Measured by the Self-Efficacy Scale)	Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.	Mean patient self-efficacy scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in self-efficacy between the intervention and control arm over time. Score range: 1-4. Higher score means better outcome.
Change in Family Caregiver Activation (as Measured by the FCG Activation in Transitions Tool)	Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.	Mean caregiver activation scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in activation between the intervention and control arm over time. Score range: 10-60. Higher score means better outcome.
Change in Patient Activation (as Measured by the Patient Activation Measure)	Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.	Mean patient activation scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in activation between the intervention and control arm over time. Score range: 0-100. Higher score means better outcome.
Change in Family Caregiver Knowledge (as Measured by the Surgery-Related Knowledge Tool)	Outcomes are measured at baseline, 1 month, and 3 months post-discharge	Mean family caregiver knowledge scores from baseline to 3 months post-discharge were calculated. T-tests were used to assess differences in knowledge between the intervention and control arm at different timepoints. Score range: 0-10. Mean: 8.24 with a standard deviation of 1.19. Higher score means better outcome.
Change in Patient Knowledge (as Measured by the Surgery-Related Knowledge Tool)	Outcomes are measured at baseline, 1 month, and 3 months post-discharge	Mean patient knowledge scores from baseline to 3 months post-discharge were calculated. T-tests were used to assess differences in knowledge between the intervention and control arm at different timepoints. Score range: 0-10. Mean: 8.42 with a standard deviation of 1.16. Higher score means better outcome.