CaregiverNCT03686007

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

A study testing Informational Intervention and Media Intervention in people with Caregiver and Stage I Lung Cancer AJCC v7, run by City of Hope Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Caregiver, Stage I Lung Cancer AJCC v7, Stage IA Lung Cancer AJCC v7
What is being tested?: Informational Intervention and Media Intervention
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 380 participants
Where: 1 siteUnited States
Study dates: 6 Nov 2018to 14 Dec 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

City of Hope Medical Center
Duarte, California, 91010

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

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:

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: 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
Being tested: Informational Intervention, Media Intervention
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Informational InterventionOther
Receive MSM intervention handbook
Informational InterventionOther
Receive MSM intervention research nurse coaching
Informational InterventionOther
Receive ASCO print materials
Informational InterventionOther
Receive CRA assistance
Media InterventionOther
View the MSM intervention videos
Media InterventionOther
View American Cancer Society (ACS) videos

Study groups in NCT03686007
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Informational Intervention; Other: Media Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Outcomes are measured at baseline, 1 month, and 3 months post-discharge
Change in Patient Knowledge (as Measured by the Surgery-Related Knowledge Tool)
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.
Measured: Outcomes are measured at baseline, 1 month, and 3 months post-discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Nov 201814 Dec 2026

First posted26 Sep 2018
Study start6 Nov 2018
Primary completion31 Aug 2024
Study completion14 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CaregiverStudies of the same condition, open and under way.
More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 380 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03686007
Sponsor's protocol ID: 17238
Other IDs: NCI-2017-01391, 17238
Status last verified: Feb 2026
First submitted: 1 Aug 2017
Last updated: 20 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 31279090

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multimedia Self-management Intervention to Prepare Family Caregivers and Patients for Lung Cancer Surgery
ClinicalTrials.gov ID: NCT03686007
Acronym / sponsor ID: 17238
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
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 380 participants (actual)
Lead sponsor: City of Hope Medical CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 6 Nov 2018 (actual)
Primary completion: 31 Aug 2024 (actual)
Study completion: 14 Dec 2026 (estimated)
First posted: 26 Sep 2018 (actual)
Results: Posted 27 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

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:

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group I (MSM intervention)	Experimental	Other: Informational Intervention, Other: Media InterventionPatients 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.
Group II (Attention Control)	Active comparator	Other: Informational Intervention, Other: Media InterventionPatients 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.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Informational InterventionReceive MSM intervention handbook	Other	Group I (MSM intervention)
Informational InterventionReceive MSM intervention research nurse coaching	Other	Group I (MSM intervention)
Informational InterventionReceive ASCO print materials	Other	Group II (Attention Control)
Informational InterventionReceive CRA assistance	Other	Group II (Attention Control)
Media InterventionView the MSM intervention videos	Other	Group I (MSM intervention)
Media InterventionView American Cancer Society (ACS) videos	Other	Group II (Attention Control)

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.

6 secondary outcomes

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.
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.
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.
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.
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
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

Results and safety

Results posted to the registry on 27 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group I (MSM Intervention)	188	156
Group II (Attention Control)	192	155

Primary outcome: 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 (95% Confidence Interval). Unit: score on a scale

Measure	Group I (MSM Intervention) n = 92	Group II (Attention Control) n = 96
Baseline	3.92 (3.38 to 4.47)	4.19 (3.65 to 4.72)
1 month post-discharge	3.38 (2.79 to 3.98)	3.74 (3.12 to 4.36)
3 months post-discharge	3.22 (2.62 to 3.82)	4.14 (3.54 to 4.74)

Population analysed: Due to attrition in the study, the number of family caregivers assessed at baseline differs from the number of family caregivers analyzed during follow-up.

Primary outcome: 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 (95% Confidence Interval). Unit: score on a scale

Measure	Group I (MSM Intervention) n = 93	Group II (Attention Control) n = 95
Baseline	44.68 (43.01 to 46.35)	44.56 (42.91 to 46.21)
1 month post-discharge	42.19 (40.36 to 44.02)	44.73 (42.83 to 46.63)
3 months post-discharge	40.45 (38.63 to 42.27)	42.00 (40.18 to 43.82)

Population analysed: Due to attrition in the study, the number of family caregivers assessed at baseline differs from the number of family caregivers analyzed during follow-up.

Primary outcome: 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 (95% Confidence Interval). Unit: score on a scale

Measure	Group I (MSM Intervention) n = 93	Group II (Attention Control) n = 95
Baseline	2.55 (2.38 to 2.72)	2.60 (2.44 to 2.77)
1 month post-discharge	2.98 (2.80 to 3.16)	2.88 (2.70 to 3.07)
3 months post-discharge	2.94 (2.76 to 3.12)	2.78 (2.60 to 2.96)

Population analysed: Due to attrition in the study, the number of family caregivers assessed at baseline differs from the number of family caregivers analyzed during follow-up.

Primary outcome: 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 (95% Confidence Interval). Unit: score on a scale

Measure	Group I (MSM Intervention) n = 93	Group II (Attention Control) n = 94
Baseline	27.04 (25.85 to 28.22)	26.83 (25.65 to 28.01)
1 month post-discharge	27.69 (26.45 to 28.94)	26.67 (25.40 to 27.94)
3 months post-discharge	27.51 (26.27 to 28.76)	26.43 (25.20 to 27.67)

Population analysed: Due to attrition in the study, the number of family caregivers assessed at baseline differs from the number of family caregivers analyzed during follow-up.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: This is an intervention trial that lasts 3 months post-treatment with no blood draws, procedures, etc. Since this is not a drug trial, patients and caregivers were not assessed for specific adverse events however, 1 patient died during the study due to acute respiratory failure with hypoxia, not due to study participation. The time frame where each participant was monitored for death was during the 3 months post-discharge.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group I (MSM Intervention)	0 of 0	0 of 0	1 of 188
Group II (Attention Control)	0 of 0	0 of 0	0 of 192

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31279090Sun 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Virginia Sun, RN, PhD principal investigator

City of Hope Medical Center

Jae Kim, MD principal investigator

City of Hope Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Informational Intervention and Media Intervention in people with Caregiver and Stage I Lung Cancer AJCC v7, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03686007, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.