Multimedia Self-Management Intervention for Lung Cancer Surgery Family Caregivers and Patients
NCT ID: NCT03686007
Last Updated: 2025-04-27
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
380 participants
INTERVENTIONAL
2018-11-06
2026-01-13
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Informational Intervention
Receive MSM intervention handbook
Informational Intervention
Receive MSM intervention research nurse coaching
Media Intervention
View the MSM intervention videos
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.
Informational Intervention
Receive ASCO print materials
Informational Intervention
Receive CRA assistance
Media Intervention
View American Cancer Society (ACS) videos
Interventions
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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 American Cancer Society (ACS) videos
Eligibility Criteria
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Inclusion Criteria
* A patient/care recipient enrolled in the study
* Age 21 years or older
* Able to read or understand English
* 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.
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Virginia Sun, RN, PhD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Jae Kim, MD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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References
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Sun V, Raz DJ, Erhunmwunsee L, Ruel N, Carranza J, Prieto R, Ferrell B, Krouse RS, McCorkle R, Kim JY. Improving family caregiver and patient outcomes in lung cancer surgery: Study protocol for a randomized trial of the multimedia self-management (MSM) intervention. Contemp Clin Trials. 2019 Aug;83:88-96. doi: 10.1016/j.cct.2019.07.002. Epub 2019 Jul 3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2017-01391
Identifier Type: REGISTRY
Identifier Source: secondary_id
17238
Identifier Type: OTHER
Identifier Source: secondary_id
17238
Identifier Type: -
Identifier Source: org_study_id
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