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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01391 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 17238 | Other Identifier | City of Hope Medical Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Informational Intervention | Other | Receive MSM intervention handbook |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. |
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Family Caregiver Inclusion Criteria:
Patient Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia Sun, RN, PhD | City of Hope Medical Center | Principal Investigator |
| Jae Kim, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31279090 | Derived | 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. |
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542 participants (342 patients, 200 caregivers) were assessed for study eligibility. After 162 participants were excluded for various reasons - not meeting inclusion criteria (n= 91), declined to participate (n= 48), other/unknown reasons (n= 3), late ineligibility (n= 20), 380 participants (190 dyads - 190 patients, 190 caregivers) were randomized.
542 participants (342 patients, 200 caregivers) were assessed for study eligibility. After 162 participants were excluded for various reasons - not meeting inclusion criteria (n= 91), declined to participate (n= 48), other/unknown reasons (n= 3), late ineligibility (n= 20), 380 participants (190 dyads - 190 patients, 190 caregivers) were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2023 |
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| Informational Intervention |
| Other |
Receive MSM intervention research nurse coaching |
|
| Informational Intervention | Other | Receive ASCO print materials |
|
| Informational Intervention | Other | Receive CRA assistance |
|
| Media Intervention | Other | View the MSM intervention videos |
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| Media Intervention | Other | View American Cancer Society (ACS) videos |
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| 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. |
| 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. | 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. | 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. | 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. | 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. | Outcomes are measured at baseline, 1 month, and 3 months post-discharge |
| FG001 | 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 ASCO Cancer.net videos |
| COMPLETED |
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| NOT COMPLETED |
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This baseline table includes data for patients and caregivers.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| BG001 | 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 ASCO Cancer.net videos |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Due to missing item responses and no separate category for "Unknown" sex, the number of participants analyzed differs from the overall number of participants. | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. |
|
|
| ||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. |
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| Primary | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Outcomes are measured before surgery (baseline), 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. |
| ||||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. |
| ||||||||||||||||||||||||||||||
| Primary | 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. | Due to attrition in the study, the number of family caregivers assessed at discharge differs from the number of family caregivers analyzed during follow-up. | Posted | Count of Participants | Participants | Outcomes are measured at discharge, 1 month, and 3 months post-discharge. |
| |||||||||||||||||||||||||||||||
| Primary | 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. | Due to attrition in the study, the number of patients assessed at baseline differs from the number of patients analyzed during follow-up. | Posted | Mean | 95% Confidence Interval | score on a scale | Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. |
| ||||||||||||||||||||||||||||||
| Primary | 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. | Due to attrition in the study, the number of patients assessed at baseline differs from the number of patients analyzed during follow-up. | Posted | Mean | 95% Confidence Interval | score on a scale | Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. |
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| Primary | 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. | Due to attrition in the study, the number of patients assessed differed during follow-up timepoints. | Posted | Count of Participants | Participants | Outcomes are measured at 1 month, and 3 months post-discharge. |
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| Secondary | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. |
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| Secondary | 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. | Due to attrition in the study, the number of patients assessed at baseline differs from the number of patients analyzed during follow-up. | Posted | Mean | 95% Confidence Interval | score on a scale | Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. |
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| Secondary | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. |
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| Secondary | 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. | Due to attrition in the study, the number of patients assessed at baseline differs from the number of patients analyzed during follow-up. | Posted | Mean | 95% Confidence Interval | score on a scale | Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | T-score | Outcomes are measured at baseline, 1 month, and 3 months post-discharge |
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| Secondary | 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. | Due to attrition in the study, the number of patients assessed at baseline differs from the number of patients analyzed during follow-up. | Posted | Mean | Standard Deviation | T-score | Outcomes are measured at baseline, 1 month, and 3 months post-discharge |
|
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.
Since this is not a drug trial, adverse events were not recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | 1 | 188 | 0 | 0 | 0 | 0 |
| EG001 | 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 ASCO Cancer.net videos | 0 | 192 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Virginia Sun | City of Hope Medical Center | 626-359-8111 | VSun@coh.org |
| Mar 13, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 7, 2023 | Mar 14, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| 1 month post-discharge |
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| 3 months post-discharge |
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| OG001 |
| 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 ASCO Cancer.net videos |
|
|
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 ASCO Cancer.net 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 ASCO Cancer.net videos |
|
|
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|
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 ASCO Cancer.net 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 ASCO Cancer.net videos |
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|
|
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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 ASCO Cancer.net videos
|
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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 ASCO Cancer.net videos
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