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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| Dana-Farber Cancer Institute | OTHER |
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This research study is evaluating a behavioral intervention designed to help people with advanced lung cancer manage dyspnea (i.e., breathlessness or shortness-of-breath).
Many individuals with advanced lung cancer experience debilitating breathlessness at some point during the course of their illness. Unfortunately, few interventions exist to treat this distressing symptom of cancer.
The purpose of this study is to test the efficacy of a brief behavioral intervention may help relieve breathlessness in individuals with advanced lung cancer. Participants will have a 50/50 chance of receiving the behavioral intervention or standard care. The principal investigator of the study, Dr. Joseph Greer, is a licensed clinical psychologist who has trained oncology nurses in how to deliver the behavioral intervention. The oncology nurses will meet with participants during their outpatient oncology appointments, such as chemotherapy infusions, to review the behavioral skills that may help with breathlessness. This intervention involves no medications but rather teaches patients skills for breathing control and relaxation of the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians. |
|
| Dyspnea Intervention | Experimental | Dyspnea intervention will be administered over two sessions Patients will receive:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dyspnea Intervention | Behavioral | Dyspnea intervention will be administered over two sessions Patients will receive:
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Medical Research Council Dyspnea Scale (mMRCDS) | Compare the difference between study groups in the Modified Medical Research Council Dyspnea Scale severity score at 8 weeks. The Modified Medical Research Council Dyspnea Scale scores range from 0 (minimum) to 4 (maximum), with higher scores indicating more severe dyspnea. | 8 weeks |
| Cancer Dyspnoea Scale (CDS) | Compare the difference between study groups in the Cancer Dyspnoea Scale scores at 8 weeks. The Cancer Dyspnoea Scale scores range from 0 (minimum) to 48 (maximum), with higher scores indicating worse dyspnea. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy - Lung (FACT-L) | Compare the difference between study groups in the Functional Assessment of Cancer Therapy - Lung Scale scores at 8 weeks. The Functional Assessment of Cancer Therapy - Lung Scale scores range from 0 (minimum) to 136 (maximum), with higher scores indicating better quality of life. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Medical Research Council Dyspnea Scale (mMRCDS) | Compare the difference between study groups in the estimated slopes of the scores on the Modified Medical Research Council Dyspnea Scale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Modified Medical Research Council Dyspnea Scale scores range from 0 (minimum) to 4 (maximum), with higher scores indicating more severe dyspnea. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Greer, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39088766 | Derived | Greer JA, Post KE, Chabria R, Aribindi S, Brennan N, Eche-Ugwu IJ, Halpenny B, Fox E, Lo S, Waldman LP, Pintro K, Rabideau DJ, Pirl WF, Cooley ME, Temel JS. Randomized Controlled Trial of a Nurse-Led Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer. J Clin Oncol. 2024 Oct 20;42(30):3570-3580. doi: 10.1200/JCO.24.00048. Epub 2024 Aug 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians. Usual Care: Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians |
| FG001 | Dyspnea Intervention | Dyspnea intervention will be administered over two sessions Patients will receive:
Dyspnea Intervention: Dyspnea intervention will be administered over two sessions Patients will receive:
Usual Care: Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians. Usual Care: Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians |
| BG001 | Dyspnea Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Modified Medical Research Council Dyspnea Scale (mMRCDS) | Compare the difference between study groups in the Modified Medical Research Council Dyspnea Scale severity score at 8 weeks. The Modified Medical Research Council Dyspnea Scale scores range from 0 (minimum) to 4 (maximum), with higher scores indicating more severe dyspnea. | Reasons for missing data include participants being unable to complete study measures due to worsening illness or death, withdrawing from the study, declining to complete the measures, or being lost to follow-up or transferring care. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 weeks |
|
From enrollment (baseline) through 24 weeks.
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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 | Usual Care | Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians. Usual Care: Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph A. Greer, Ph.D. | Massachusetts General Hospital | 617-643-2143 | jgreer2@mgh.harvard.edu |
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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 | Nov 15, 2021 | Dec 31, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Nurse administered dyspnea intervention
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Research staff collecting patient-reported measures will be blind to study assignment group
| Usual Care | Other | Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians |
|
| Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | Compare the difference between study groups in the Hospital Anxiety and Depression Scale - Anxiety Subscale scores at 8 weeks. The Hospital Anxiety and Depression Scale - Anxiety Subscale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating worse anxiety symptoms. | 8 weeks |
| Hospital Anxiety and Depression Scale (HADS) - Depression Subscale | Compare the difference between study groups in the Hospital Anxiety and Depression Scale - Depression Subscale scores at 8 weeks. The Hospital Anxiety and Depression Scale - Depression Subscale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating worse depression symptoms. | 8 weeks |
| Activity Level (Self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire) | Compare the difference between study groups in the Godin-Shephard Leisure Time Physical Activity Questionnaire scores at 8 weeks. The Godin-Shephard Leisure Time Physical Activity Questionnaire is a 4-item measure that assesses the frequency and extent of physical activity during free time over the course of one week, with scores ranging from 0 (minimum; insufficiently active) to 24 or greater (maximum; active), with higher scores indicating greater physical activity. | 8 weeks |
| Activity Level (Objective Measure: Actigraphy) | Compare the difference between study groups in the percentage of time spent immobile but awake over a consecutive three day period per actigraphy at 8 weeks. Scores range from 0% to 100%, with higher scores indicating a greater percentage of time spent immobile while awake over a consecutive three day period. | 8 weeks |
| 24 weeks |
| Cancer Dyspnoea Scale (CDS) | Compare the difference between study groups in the estimated slopes of the scores on the Cancer Dyspnoea Scale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Cancer Dyspnoea Scale scores range from 0 (minimum) to 48 (maximum), with higher scores indicating worse dyspnea. | 24 weeks |
| Functional Assessment of Cancer Therapy - Lung (FACT-L) | Compare the difference between study groups in the estimated slopes of the scores on the Functional Assessment of Cancer Therapy - Lung Scale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Functional Assessment of Cancer Therapy - Lung Scale scores range from 0 (minimum) to 136 (maximum), with higher scores indicating better quality of life. | 24 weeks |
| Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | Compare the difference between study groups in the estimated slopes of the scores on the Hospital Anxiety and Depression Scale - Anxiety Subscale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Hospital Anxiety and Depression Scale - Anxiety Subscale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating worse anxiety symptoms. | 24 weeks |
| Hospital Anxiety and Depression Scale (HADS) - Depression Subscale | Compare the difference between study groups in the estimated slopes of the scores on the Hospital Anxiety and Depression Scale - Depression Subscale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Hospital Anxiety and Depression Scale - Depression Subscale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating worse depression symptoms. | 24 weeks |
| Activity Level (Self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire) | Compare the difference between study groups in the estimated slopes of the scores on the Godin-Shephard Leisure Time Physical Activity Questionnaire over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Godin-Shephard Leisure Time Physical Activity Questionnaire is a 4-item measure that assesses the frequency and extent of physical activity during free time over the course of one week, with scores ranging from 0 (minimum; insufficiently active) to 24 or greater (maximum; active), with higher scores indicating greater physical activity. | 24 weeks |
| Examine Potential Mediators of Intervention Effects on Patient-reported Outcomes | Examine the degree to which intervention effects on patient reported outcomes are mediated by improved mastery in managing breathlessness (as measured by the Chronic Respiratory Disease Questionnaire) | 24 weeks |
| Examine Potential Moderators of Intervention Effects on Dyspnea | Examine whether differences in reported dyspnea are moderated by patient demographic and clinical factors | 24 weeks |
| Health Service Utilization | Examine differences between study groups in rates of emergency department and hospitalizations | 24 weeks |
| Boston |
| Massachusetts |
| 02115 |
| United States |
Dyspnea intervention will be administered over two sessions Patients will receive:
Dyspnea Intervention: Dyspnea intervention will be administered over two sessions Patients will receive:
Usual Care: Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Modified Medical Research Council Dyspnea Scale (mMRCDS) | The Modified Medical Research Council Dyspnea Scale evaluates dyspnea-related functional impairment. Total scale score range: 0 (minimum) to 4 (maximum), with higher scores indicating worse dyspnea. | Mean | Standard Deviation | units on a scale |
|
| Cancer Dyspnoea Scale (CDS) | The Cancer Dyspnoea Scale assesses dyspnea-related effort, anxiety, and physical discomfort. Total scale score range: 0 (minimum) to 48 (maximum), with higher scores indicating worse dyspnea. | Mean | Standard Deviation | units on a scale |
|
| Functional Assessment of Cancer Therapy - Lung (FACT-L) | The Functional Assessment of Cancer Therapy - Lung Scale measures overall quality of life, including physical, social, emotional, and functional wellbeing as well as lung cancer-specific symptoms. Total scale score range: 0 (minimum) to 136 (maximum), with higher scores indicating better quality of life. | Mean | Standard Deviation | units on a scale |
|
| Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | The Hospital Anxiety and Depression Scale - Anxiety Subscale assesses anxiety symptoms in the past week. Total subscale score range: 0 (minimum) to 21 (maximum), with higher scores indicating worse anxiety symptoms. | Mean | Standard Deviation | units on a scale |
|
| Hospital Anxiety and Depression Scale (HADS) - Depression Subscale | The Hospital Anxiety and Depression Scale - Depression Subscale assesses depression symptoms in the past week. Total subscale score range: 0 (minimum) to 21 (maximum), with higher scores indicating worse depression symptoms. | Mean | Standard Deviation | units on a scale |
|
| Godin-Shephard Leisure Time Physical Activity Questionnaire | The Godin-Shephard Leisure Time Physical Activity Questionnaire assesses the frequency and extent of physical activity over the course of one week. Total scale score range: 0 (minimum; insufficiently active) to 24 or greater (maximum; active), with higher scores indicating greater physical activity. | 6 participants in the Usual Care Group and 9 participants in the Dyspnea Intervention Group did not complete the baseline Godin-Shephard Leisure Time Physical Activity Questionnaire. | Mean | Standard Deviation | units on a scale |
|
| Actigraphy | Participants were asked to wear a wrist actigraph device during a consecutive 3-day period at baseline and again at week 8 (primary outcome time point). Percentages (0-100%) represent proportion of time spent immobile while awake. | 37 participants in the Usual Care Group and 37 participants in the Dyspnea Intervention Group did not have three consecutive days of actigraphy data at baseline. | Mean | Standard Deviation | Percent time spent immobile while awake |
|
| OG001 | Dyspnea Intervention | Dyspnea intervention will be administered over two sessions Patients will receive:
Dyspnea Intervention: Dyspnea intervention will be administered over two sessions Patients will receive:
Usual Care: Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians |
|
|
|
| Primary | Cancer Dyspnoea Scale (CDS) | Compare the difference between study groups in the Cancer Dyspnoea Scale scores at 8 weeks. The Cancer Dyspnoea Scale scores range from 0 (minimum) to 48 (maximum), with higher scores indicating worse dyspnea. | Reasons for missing data include participants being unable to complete study measures due to worsening illness or death, withdrawing from the study, declining to complete the measures, or being lost to follow-up or transferring care. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 weeks |
|
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|
|
| Secondary | Functional Assessment of Cancer Therapy - Lung (FACT-L) | Compare the difference between study groups in the Functional Assessment of Cancer Therapy - Lung Scale scores at 8 weeks. The Functional Assessment of Cancer Therapy - Lung Scale scores range from 0 (minimum) to 136 (maximum), with higher scores indicating better quality of life. | Reasons for missing data include participants being unable to complete study measures due to worsening illness or death, withdrawing from the study, declining to complete the measures, or being lost to follow-up or transferring their care to another institution. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 weeks |
|
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| Secondary | Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | Compare the difference between study groups in the Hospital Anxiety and Depression Scale - Anxiety Subscale scores at 8 weeks. The Hospital Anxiety and Depression Scale - Anxiety Subscale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating worse anxiety symptoms. | Reasons for missing data include participants being unable to complete study measures due to worsening illness or death, withdrawing from the study, declining to complete the measures, or being lost to follow-up or transferring their care to another institution. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 weeks |
|
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|
|
| Secondary | Hospital Anxiety and Depression Scale (HADS) - Depression Subscale | Compare the difference between study groups in the Hospital Anxiety and Depression Scale - Depression Subscale scores at 8 weeks. The Hospital Anxiety and Depression Scale - Depression Subscale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating worse depression symptoms. | Reasons for missing data include participants being unable to complete study measures due to worsening illness or death, withdrawing from the study, declining to complete the measures, or being lost to follow-up or transferring their care to another institution. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 weeks |
|
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| Secondary | Activity Level (Self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire) | Compare the difference between study groups in the Godin-Shephard Leisure Time Physical Activity Questionnaire scores at 8 weeks. The Godin-Shephard Leisure Time Physical Activity Questionnaire is a 4-item measure that assesses the frequency and extent of physical activity during free time over the course of one week, with scores ranging from 0 (minimum; insufficiently active) to 24 or greater (maximum; active), with higher scores indicating greater physical activity. | Reasons for missing data include participants being unable to complete study measures due to worsening illness or death, withdrawing from the study, declining to complete the measures, or being lost to follow-up or transferring their care to another institution. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 weeks |
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| Secondary | Activity Level (Objective Measure: Actigraphy) | Compare the difference between study groups in the percentage of time spent immobile but awake over a consecutive three day period per actigraphy at 8 weeks. Scores range from 0% to 100%, with higher scores indicating a greater percentage of time spent immobile while awake over a consecutive three day period. | Reasons for missing data include participants being unable to complete study measures due to worsening illness or death, withdrawing from the study, declining to complete the measures, or being lost to follow-up or transferring their care to another institution. | Posted | Mean | 95% Confidence Interval | percent time spent immobile while awake | 8 weeks |
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| Other Pre-specified | Modified Medical Research Council Dyspnea Scale (mMRCDS) | Compare the difference between study groups in the estimated slopes of the scores on the Modified Medical Research Council Dyspnea Scale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Modified Medical Research Council Dyspnea Scale scores range from 0 (minimum) to 4 (maximum), with higher scores indicating more severe dyspnea. | The analysis sample includes the total number of participants by group who completed at least one Modified Medical Research Council Dyspnea Scale outcome measure from baseline to 24 weeks. | Posted | Least Squares Mean | 95% Confidence Interval | mean change in scores on a scale | 24 weeks |
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| Other Pre-specified | Cancer Dyspnoea Scale (CDS) | Compare the difference between study groups in the estimated slopes of the scores on the Cancer Dyspnoea Scale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Cancer Dyspnoea Scale scores range from 0 (minimum) to 48 (maximum), with higher scores indicating worse dyspnea. | The analysis sample includes the total number of participants by group who completed at least one Cancer Dyspnoea Scale outcome measure from baseline to 24 weeks. | Posted | Least Squares Mean | 95% Confidence Interval | mean change in scores on a scale | 24 weeks |
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| Other Pre-specified | Functional Assessment of Cancer Therapy - Lung (FACT-L) | Compare the difference between study groups in the estimated slopes of the scores on the Functional Assessment of Cancer Therapy - Lung Scale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Functional Assessment of Cancer Therapy - Lung Scale scores range from 0 (minimum) to 136 (maximum), with higher scores indicating better quality of life. | The analysis sample includes the total number of participants by group who completed at least one Functional Assessment of Cancer Therapy - Lung Scale outcome measure from baseline to 24 weeks. | Posted | Least Squares Mean | 95% Confidence Interval | mean change in scores on a scale | 24 weeks |
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| Other Pre-specified | Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | Compare the difference between study groups in the estimated slopes of the scores on the Hospital Anxiety and Depression Scale - Anxiety Subscale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Hospital Anxiety and Depression Scale - Anxiety Subscale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating worse anxiety symptoms. | The analysis sample includes the total number of participants by group who completed at least one Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale outcome measure from baseline to 24 weeks. | Posted | Least Squares Mean | 95% Confidence Interval | mean change in scores on a scale | 24 weeks |
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| Other Pre-specified | Hospital Anxiety and Depression Scale (HADS) - Depression Subscale | Compare the difference between study groups in the estimated slopes of the scores on the Hospital Anxiety and Depression Scale - Depression Subscale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Hospital Anxiety and Depression Scale - Depression Subscale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating worse depression symptoms. | The analysis sample includes the total number of participants by group who completed at least one Hospital Anxiety and Depression Scale - Depression Subscale outcome measure from baseline to 24 weeks. | Posted | Least Squares Mean | 95% Confidence Interval | mean change in scores on a scale | 24 weeks |
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| Other Pre-specified | Activity Level (Self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire) | Compare the difference between study groups in the estimated slopes of the scores on the Godin-Shephard Leisure Time Physical Activity Questionnaire over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Godin-Shephard Leisure Time Physical Activity Questionnaire is a 4-item measure that assesses the frequency and extent of physical activity during free time over the course of one week, with scores ranging from 0 (minimum; insufficiently active) to 24 or greater (maximum; active), with higher scores indicating greater physical activity. | The analysis sample includes the total number of participants by group who completed at least one Godin-Shephard Leisure Time Physical Activity Questionnaire outcome measure from baseline to 24 weeks. | Posted | Least Squares Mean | 95% Confidence Interval | mean change in scores on a scale | 24 weeks |
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| Other Pre-specified | Examine Potential Mediators of Intervention Effects on Patient-reported Outcomes | Examine the degree to which intervention effects on patient reported outcomes are mediated by improved mastery in managing breathlessness (as measured by the Chronic Respiratory Disease Questionnaire) | Not Posted | 24 weeks | Participants |
| Other Pre-specified | Examine Potential Moderators of Intervention Effects on Dyspnea | Examine whether differences in reported dyspnea are moderated by patient demographic and clinical factors | Not Posted | 24 weeks | Participants |
| Other Pre-specified | Health Service Utilization | Examine differences between study groups in rates of emergency department and hospitalizations | Not Posted | 24 weeks | Participants |
| 23 |
| 121 |
| 0 |
| 121 |
| 0 |
| 121 |
| EG001 | Dyspnea Intervention | Dyspnea intervention will be administered over two sessions Patients will receive:
Dyspnea Intervention: Dyspnea intervention will be administered over two sessions Patients will receive:
Usual Care: Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians | 17 | 126 | 0 | 126 | 0 | 126 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|