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

NCT03686007 | Active Not Recruiting Results DMC

• 2 other identifiers: 17238NCI-2017-01391
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (8)

• Change in Family Caregiver Psychological Distress (as Measured by the Distress Thermometer)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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 Outcomes (6)

• 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.

• 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.

• 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.

• 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.

• 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

Study Arms (2)

Group I (MSM intervention)

EXPERIMENTAL

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: Informational Intervention; Other: Media Intervention

Group II (Attention Control)

ACTIVE COMPARATOR

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; Other: Media Intervention

Interventions

Media Intervention OTHER

View the MSM intervention videos

Group I (MSM intervention)

Informational Intervention OTHER

Receive MSM intervention handbook

Group I (MSM intervention)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Related Publications (1)

• 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.

  PMID: 31279090 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Virginia Sun
• Organization: City of Hope Medical Center

VSun@coh.org

626-359-8111

Study Officials

• Virginia Sun, RN, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

• Jae Kim, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: September 26, 2018
• Study Start: November 6, 2018
• Primary Completion: August 31, 2024
• Study Completion (Estimated): December 14, 2026
• Last Updated: February 20, 2026
• Results First Posted: April 27, 2025

Record last verified: 2026-02

Locations

US (1)