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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Duarte, California, United States, 91010
- City of Hope Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group I (MSM 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.
|
Receive MSM intervention handbook
Receive MSM intervention research nurse coaching
Receive ASCO print materials
Receive CRA assistance
View the MSM intervention videos
View American Cancer Society (ACS) videos
|
|
Active Comparator: Group II (Attention Control)
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.
|
Receive MSM intervention handbook
Receive MSM intervention research nurse coaching
Receive ASCO print materials
Receive CRA assistance
View the MSM intervention videos
View American Cancer Society (ACS) videos
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Family Caregiver Psychological Distress (as Measured by the Distress Thermometer)
Time Frame: 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. |
Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
|
|
Change in Caregiving Burden (as Measured by the Montgomery Borgatta Caregiver Burden Scale)
Time Frame: 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. |
Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
|
|
Change in Preparedness for Caregiving (as Measured by the Preparedness for Caregiving Scale)
Time Frame: 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. |
Outcomes are measured before surgery (baseline), 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
|
|
Change in Family Caregiver Quality of Life (as Measured by the City of Hope-Quality of Life-Family (COH-QOL-Family)
Time Frame: 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. |
Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
|
|
Number of Participants Who Used Family Caregiver Resource (as Measured by the Family Caregiver Healthcare Use Inventory)
Time Frame: 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.
|
Outcomes are measured at discharge, 1 month, and 3 months post-discharge.
|
|
Change in Patient Psychological Distress (as Measured by the Distress Thermometer)
Time Frame: 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. |
Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
|
|
Change in Patient Quality of Life (as Measured by the Functional Assessment of Cancer Therapy-Lung - FACT-L)
Time Frame: 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. |
Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
|
|
Number of Participants Who Used Patient Healthcare Resource Use (Home Health Nursing Care, Urgent/ER Visits, Hospital Readmissions)
Time Frame: Outcomes are measured at 1 month, and 3 months post-discharge.
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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.
|
Outcomes are measured at 1 month, and 3 months post-discharge.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Family Caregiver Self-efficacy (as Measured by the Self-Efficacy Scale)
Time Frame: 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. |
Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
|
|
Change in Patient Self-efficacy (as Measured by the Self-Efficacy Scale)
Time Frame: 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. |
Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
|
|
Change in Family Caregiver Activation (as Measured by the FCG Activation in Transitions Tool)
Time Frame: 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. |
Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
|
|
Change in Patient Activation (as Measured by the Patient Activation Measure)
Time Frame: 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. |
Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
|
|
Change in Family Caregiver Knowledge (as Measured by the Surgery-Related Knowledge Tool)
Time Frame: 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. |
Outcomes are measured at baseline, 1 month, and 3 months post-discharge
|
|
Change in Patient Knowledge (as Measured by the Surgery-Related Knowledge Tool)
Time Frame: 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. |
Outcomes are measured at baseline, 1 month, and 3 months post-discharge
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Virginia Sun, RN, PhD, City of Hope Medical Center
- Principal Investigator: Jae Kim, MD, City of Hope Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17238 (Other Identifier: City of Hope Medical Center)
- NCI-2017-01391 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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