Lung Cancer
Conditions
Keywords
Lung Cancer
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALDyspnea Intervention
Dyspnea intervention will be administered over two sessions Patients will receive: * Psychoeducation * Relaxation training for reducing physiological stress * Behavioral techniques for managing acute breathlessness
OTHERUsual Care
Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians
Sponsors
National Institute of Nursing Research (NINR)
Dana-Farber Cancer Institute
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Research staff collecting patient-reported measures will be blind to study assignment group
Intervention model description
Nurse administered dyspnea intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A diagnosis of either NSCLC, SCLC, or mesothelioma, not being treated with curative intent * Self-reported shortness of breath (a score of 2 or greater on the Modified Medical Research Council Dyspnea Scale) * Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2 (symptomatic and in bed \<50% of day) * The ability to read and respond to questions English * Primary cancer care at the Massachusetts General Hospital (MGH) Cancer Center or Dana-Farber Cancer Institute (DFCI) * Age \>18 years
Exclusion criteria
* Cognitive or psychiatric conditions prohibiting study consent or participation. * A treating clinician who reports that the patient is inappropriate for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Medical Research Council Dyspnea Scale (mMRCDS) | 8 weeks | 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. |
| Cancer Dyspnoea Scale (CDS) | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) - Depression Subscale | 8 weeks | 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. |
| Functional Assessment of Cancer Therapy - Lung (FACT-L) | 8 weeks | 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. |
| Activity Level (Objective Measure: Actigraphy) | 8 weeks | 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. |
| Activity Level (Self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire) | 8 weeks | 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. |
| Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | 8 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Examine Potential Moderators of Intervention Effects on Dyspnea | 24 weeks | Examine whether differences in reported dyspnea are moderated by patient demographic and clinical factors |
| Modified Medical Research Council Dyspnea Scale (mMRCDS) | 24 weeks | 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. |
| Health Service Utilization | 24 weeks | Examine differences between study groups in rates of emergency department and hospitalizations |
| Cancer Dyspnoea Scale (CDS) | 24 weeks | 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. |
| Functional Assessment of Cancer Therapy - Lung (FACT-L) | 24 weeks | 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. |
| Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | 24 weeks | 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. |
| Hospital Anxiety and Depression Scale (HADS) - Depression Subscale | 24 weeks | 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. |
| Activity Level (Self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire) | 24 weeks | 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. |
| Examine Potential Mediators of Intervention Effects on Patient-reported Outcomes | 24 weeks | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 121 |
| Dyspnea Intervention Dyspnea intervention will be administered over two sessions
Patients will receive:
* Psychoeducation
* Relaxation training for reducing physiological stress
* Behavioral techniques for managing acute breathlessness
Dyspnea Intervention: Dyspnea intervention will be administered over two sessions
Patients will receive:
* Psychoeducation
* Relaxation training for reducing physiological stress
* Behavioral techniques for managing acute breathlessness
Usual Care: Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians | 126 |
| Total | 247 |
Baseline characteristics
| Characteristic | Total | Dyspnea Intervention | Usual Care |
|---|---|---|---|
| Actigraphy | 49.00 Percent time spent immobile while awake STANDARD_DEVIATION 12.48 | 47.61 Percent time spent immobile while awake STANDARD_DEVIATION 11.19 | 50.48 Percent time spent immobile while awake STANDARD_DEVIATION 13.62 |
| Age, Continuous | 66.15 years STANDARD_DEVIATION 10.81 | 66.83 years STANDARD_DEVIATION 11.47 | 65.44 years STANDARD_DEVIATION 10.08 |
| Cancer Dyspnoea Scale (CDS) | 11.85 units on a scale STANDARD_DEVIATION 7.05 | 11.13 units on a scale STANDARD_DEVIATION 6.51 | 12.61 units on a scale STANDARD_DEVIATION 7.51 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 235 Participants | 117 Participants | 118 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 6 Participants | 2 Participants |
| Functional Assessment of Cancer Therapy - Lung (FACT-L) | 88.74 units on a scale STANDARD_DEVIATION 17.56 | 90.19 units on a scale STANDARD_DEVIATION 18.59 | 87.23 units on a scale STANDARD_DEVIATION 16.36 |
| Godin-Shephard Leisure Time Physical Activity Questionnaire | 11.75 units on a scale STANDARD_DEVIATION 17.53 | 12.29 units on a scale STANDARD_DEVIATION 16.91 | 11.19 units on a scale STANDARD_DEVIATION 18.2 |
| Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | 6.01 units on a scale STANDARD_DEVIATION 3.83 | 5.37 units on a scale STANDARD_DEVIATION 3.8 | 6.68 units on a scale STANDARD_DEVIATION 3.76 |
| Hospital Anxiety and Depression Scale (HADS) - Depression Subscale | 6.06 units on a scale STANDARD_DEVIATION 3.47 | 5.73 units on a scale STANDARD_DEVIATION 3.72 | 6.40 units on a scale STANDARD_DEVIATION 3.16 |
| Modified Medical Research Council Dyspnea Scale (mMRCDS) | 2.60 units on a scale STANDARD_DEVIATION 0.73 | 2.59 units on a scale STANDARD_DEVIATION 0.72 | 2.60 units on a scale STANDARD_DEVIATION 0.75 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 223 Participants | 110 Participants | 113 Participants |
| Region of Enrollment United States | 247 participants | 126 participants | 121 participants |
| Sex: Female, Male Female | 138 Participants | 68 Participants | 70 Participants |
| Sex: Female, Male Male | 109 Participants | 58 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 23 / 121 | 17 / 126 |
| other Total, other adverse events | 0 / 121 | 0 / 126 |
| serious Total, serious adverse events | 0 / 121 | 0 / 126 |
Outcome results
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Cancer Dyspnoea Scale (CDS) | 10.01 units on a scale |
| Dyspnea Intervention | Cancer Dyspnoea Scale (CDS) | 9.47 units on a scale |
p-value: >0.9995% CI: [-2.2, 1.1]ANCOVA
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Modified Medical Research Council Dyspnea Scale (mMRCDS) | 1.88 units on a scale |
| Dyspnea Intervention | Modified Medical Research Council Dyspnea Scale (mMRCDS) | 1.55 units on a scale |
p-value: 0.03895% CI: [-0.61, -0.05]ANCOVA
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Activity Level (Objective Measure: Actigraphy) | 45.80 percent time spent immobile while awake |
| Dyspnea Intervention | Activity Level (Objective Measure: Actigraphy) | 47.42 percent time spent immobile while awake |
p-value: 0.43195% CI: [-2.45, 5.71]ANCOVA
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Activity Level (Self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire) | 12.73 units on a scale |
| Dyspnea Intervention | Activity Level (Self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire) | 11.24 units on a scale |
p-value: 0.64795% CI: [-7.9, 4.92]ANCOVA
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Functional Assessment of Cancer Therapy - Lung (FACT-L) | 91.40 units on a scale |
| Dyspnea Intervention | Functional Assessment of Cancer Therapy - Lung (FACT-L) | 93.00 units on a scale |
p-value: 0.3895% CI: [-1.98, 5.18]ANCOVA
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | 5.85 units on a scale |
| Dyspnea Intervention | Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | 5.84 units on a scale |
p-value: 0.9995% CI: [-0.83, 0.82]ANCOVA
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Hospital Anxiety and Depression Scale (HADS) - Depression Subscale | 6.09 units on a scale |
| Dyspnea Intervention | Hospital Anxiety and Depression Scale (HADS) - Depression Subscale | 5.59 units on a scale |
p-value: 0.25195% CI: [-1.34, 0.35]ANCOVA
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.
Time frame: 24 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Activity Level (Self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire) | 0.54 mean change in scores on a scale |
| Dyspnea Intervention | Activity Level (Self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire) | 1.28 mean change in scores on a scale |
p-value: 0.83795% CI: [-6.33, 7.77]Mixed Models Analysis
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.
Time frame: 24 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Cancer Dyspnoea Scale (CDS) | -2.63 mean change in scores on a scale |
| Dyspnea Intervention | Cancer Dyspnoea Scale (CDS) | -2.26 mean change in scores on a scale |
p-value: 0.67795% CI: [-1.4, 2.16]Mixed Models Analysis
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)
Time frame: 24 weeks
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
Time frame: 24 weeks
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.
Time frame: 24 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Functional Assessment of Cancer Therapy - Lung (FACT-L) | 4.86 mean change in scores on a scale |
| Dyspnea Intervention | Functional Assessment of Cancer Therapy - Lung (FACT-L) | 2.91 mean change in scores on a scale |
p-value: 0.3395% CI: [-5.87, 1.97]Mixed Models Analysis
Other Pre-specified
Health Service Utilization
Examine differences between study groups in rates of emergency department and hospitalizations
Time frame: 24 weeks
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.
Time frame: 24 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | -1.00 mean change in scores on a scale |
| Dyspnea Intervention | Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | -0.28 mean change in scores on a scale |
p-value: 0.09895% CI: [-0.13, 1.59]Mixed Models Analysis
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.
Time frame: 24 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Hospital Anxiety and Depression Scale (HADS) - Depression Subscale | -0.18 mean change in scores on a scale |
| Dyspnea Intervention | Hospital Anxiety and Depression Scale (HADS) - Depression Subscale | -0.10 mean change in scores on a scale |
p-value: 0.84595% CI: [-0.76, 0.93]Mixed Models Analysis
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.
Time frame: 24 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Modified Medical Research Council Dyspnea Scale (mMRCDS) | -0.89 mean change in scores on a scale |
| Dyspnea Intervention | Modified Medical Research Council Dyspnea Scale (mMRCDS) | -0.95 mean change in scores on a scale |
p-value: 0.7195% CI: [-0.38, 0.26]Mixed Models Analysis