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NCT Number: NCT03686007

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Informational intervention

Other

Receive MSM intervention handbook

Media Intervention

Other

View the MSM intervention videos

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

    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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2026
First posted
Sep 26, 2018
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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