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

February 14, 2024 updated by: City of Hope Medical Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

355

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in family caregiver psychological distress (as measured by the Distress Thermometer)
Time Frame: outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
Change in caregiving burden (as measured by the Montgomery Borgatta Caregiver Burden Scale)
Time Frame: outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
Change in preparedness for caregiving (as measured by the Preparedness for Caregiving Scale)
Time Frame: outcomes are measured before surgery (baseline), 1 day before discharge, 1 month, and 3 months post-discharge
outcomes are measured before surgery (baseline), 1 day before discharge, 1 month, and 3 months post-discharge
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 day before discharge, 1 month, and 3 months post-discharge
outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
Change in family caregiver resource use (as measured by the Family Caregiver Healthcare Use Inventory)
Time Frame: outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
outcomes are measured at baseline, 1 day before 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 day before discharge, 1 month, and 3 months post-discharge
outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
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 day before discharge, 1 month, and 3 months post-discharge
outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
Change in patient healthcare resource use (home health nursing care, urgent/ER visits, hospital readmissions)
Time Frame: outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in family caregiver and patient self-efficacy (as measured by the Self-Efficacy Scale)
Time Frame: outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
Change in family caregiver activation (as measured by the FCG Activation in Transitions Tool)
Time Frame: outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
Change in patient activation (as measured by the Patient Activation Measure)
Time Frame: outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
Change in family caregiver and patient knowledge (as measured by the Surgery-Related Knowledge Tool)
Time Frame: outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge
outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 1, 2017

First Submitted That Met QC Criteria

September 24, 2018

First Posted (Actual)

September 26, 2018

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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