Lung Cancer
Conditions
Keywords
anxiety, Dyspnea, respiratory functioning
Brief summary
The purpose of this research study is to compare the effects of music and different levels of device-guided breathing on anxiety and shortness of breath in lung cancer survivors.
Detailed description
OBJECTIVES 1. To assess feasibility (accrual, participation, adherence, retention) of a randomized study of device-guided breathing and music in 75 post-treatment lung cancer survivors with significant anxiety. 2. To obtain preliminary data on the variability and efficacy of two doses of a device-guided breathing intervention versus a music control group for reducing anxiety (primary outcome) and for improving self-reported dyspnea and respiratory functioning (secondary outcomes) in post-treatment lung cancer survivors. 3. To select the optimal dose of the device-guided breathing intervention (15 minutes once/day or twice/day) for subsequent randomized study.
Interventions
DEVICEGroup A - Device guided breathing low dose
Group A: 15 minutes once a day, 5 days a week for 12 weeks.
DEVICEGroup B - Device guided breathing high dose
Group B - 15 minutes twice a day, 5 days a week for 12 weeks.
DEVICEGroup C - Usual Breathing Control Group
Group C - 15 minutes per day, 5 days a week for 12 weeks.
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Past History of any lung cancer * For Stage I-III disease, patients should be 2-24 months post-completion of surgery, radiation therapy and/or chemotherapy with no further planned treatment during the 12-week study and no evidence of disease. * For Stage IV disease, patients may be receiving no treatment or may be receiving maintenance treatment with a target agent, chemotherapy, or immunotherapy provided the most recent imaging does not demonstrate progressive disease. * After completion of all three screening questionnaires, participant must score accordingly on at least one questionnaire to be eligible. * Willing/able to attend brief introductory session and use assigned device for the assigned period of time (15 minutes once or twice per day), at least 5 days per week for 12 weeks * Age ≥ 18 years * Must have telephone
Exclusion criteria
* Patient does not understand English * Active lung infection * Progressive cancer (must be considered no evidence of disease or stable) * Any change in psychotropic medications in past 30 days * Hearing loss that would preclude participating in interventions. Adequate hearing to participate will be determined via: (1) Response of no to the question \[Do you have a hearing problem now?\] Participants with hearing aids will be allowed to enroll as long as their hearing is adequate to hear the sounds on the study devices. If necessary, potential study participants will receive a brief test trial with the RESPeRATE device. If they indicate inability to hear the guiding tones, they will not be enrolled in the study. Cortisol Exclusion \- Participants with endocrine disorders (e.g., diabetes and thyroid disorders) or on steroid-based medications are excluded from the cortisol portion of the study (with the exception of topical hydrocortisone that is permitted).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention - Number of Participants Who Complete the Final Assessment | 12 weeks | Retention will be calculated as the number of participants who complete the final assessment divided by number randomized. |
| Accrual Rate- Number of Patients Accrued to the Study | Time from study opening to study close ~46.42 months | The accrual rate will be calculated as the number of patients accrued to the study divided by the number of months of accrual. |
| Adherence- Amount of Time the Device is Used | 12 weeks | Adherence will be calculated as the actual amount of time the device is used divided by the prescribed time. Successful adherence will be defined as use of the device ≥80% of the time assigned. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS) | 12 weeks | To obtain preliminary data on the variability and efficacy of two doses of a device-guided breathing intervention versus a usual breathing control group for reducing anxiety. This is a 14-item self-report measure of cognitive and behavioral symptoms of anxiety and depression; clinically significant symptoms are indicated by a score of greater than or equal to 8 with a range from 0 to 42. Higher scores indicate more anxiety. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Salivary Cortisol Levels | 12 weeks | Cortisol levels will be assessed upon awakening, 30 minutes post-awakening, and at bedtime for three consecutive days at baseline and three consecutive days. |
| Gene Expression Levels | 12 weeks | The DNA methylation and gene expression patterns between the different groups. |
| DNA Methylation Levels | 12 weeks | DNA methylation levels will be measured To determine if changes in anxiety are associated with methylation |
Countries
United States
Participant flow
Recruitment details
Implementation was facilitated through the Wake Forest National Cancer Institute Community Oncology Research Program (NCORP), developed to increase community participation in cancer trials. Forty-six participants were accrued between July 30 2015 and June 11 2019 (0.99 participants/month).
Pre-assignment details
In this feasibility study, participants were stratified by baseline self-reported dyspnea score and randomized to a 12-week high-dose or low-dose device-guided breathing intervention versus a usual breathing control group with equal probability, using variable length permuted block randomization. All participants enrolled were randomized and included in analyses.
Participants by arm
| Arm | Count |
|---|---|
| Group A Group A - Device Guided Breathing Low Dose
Group A - Device guided breathing low dose: Group A: 15 minutes once a day, 5 days a week for 12 weeks. | 14 |
| Group B Group B - Device guided breathing high dose
Group B - Device guided breathing high dose: Group B - 15 minutes twice a day, 5 days a week for 12 weeks. | 14 |
| Group C Group C - Usual Breathing Control Group
Group C - Usual Breathing Control Group: Group C - 15 minutes per day, 5 days a week for 12 weeks. | 18 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 6 | 3 |
Baseline characteristics
| Characteristic | Group A | Total | Group C | Group B |
|---|---|---|---|---|
| Age, Continuous | 63 years | 65 years | 66 years | 64 years |
| Age, Customized Age <50 | 1 Participants | 5 Participants | 1 Participants | 3 Participants |
| Age, Customized Age >=50 years | 13 Participants | 41 Participants | 17 Participants | 11 Participants |
| Cancer Dyspnea Scale <8 | 6 Participants | 21 Participants | 9 Participants | 6 Participants |
| Cancer Dyspnea Scale >=8 | 8 Participants | 25 Participants | 9 Participants | 8 Participants |
| Current Smoker No | 12 Participants | 36 Participants | 14 Participants | 10 Participants |
| Current Smoker Yes | 2 Participants | 10 Participants | 4 Participants | 4 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 | 6 Participants | 18 Participants | 6 Participants | 6 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 | 8 Participants | 23 Participants | 8 Participants | 7 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 2 | 0 Participants | 5 Participants | 4 Participants | 1 Participants |
| Education College graduate or some college | 10 Participants | 32 Participants | 13 Participants | 9 Participants |
| Education High School or Less | 2 Participants | 3 Participants | 1 Participants | 0 Participants |
| Education Post College Graduate Education | 2 Participants | 11 Participants | 4 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 46 Participants | 18 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Income $20,000 - $49,999 | 5 Participants | 18 Participants | 8 Participants | 5 Participants |
| Income $50,000 or more | 2 Participants | 9 Participants | 2 Participants | 5 Participants |
| Income Under $20,000 | 4 Participants | 12 Participants | 6 Participants | 2 Participants |
| Income Unknown | 3 Participants | 7 Participants | 2 Participants | 2 Participants |
| Marital Status Married | 8 Participants | 29 Participants | 13 Participants | 8 Participants |
| Marital Status Separated/Divorced/Widowed | 6 Participants | 14 Participants | 2 Participants | 6 Participants |
| Marital Status Single | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Marital Status Unknown | 0 Participants | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 36 Participants | 14 Participants | 12 Participants |
| Region of Enrollment United States | 14 participants | 46 participants | 18 participants | 14 participants |
| Sex: Female, Male Female | 10 Participants | 35 Participants | 13 Participants | 12 Participants |
| Sex: Female, Male Male | 4 Participants | 11 Participants | 5 Participants | 2 Participants |
| Stage of Disease I | 2 Participants | 15 Participants | 7 Participants | 6 Participants |
| Stage of Disease II | 2 Participants | 5 Participants | 2 Participants | 1 Participants |
| Stage of Disease III | 3 Participants | 8 Participants | 1 Participants | 4 Participants |
| Stage of Disease IV | 7 Participants | 18 Participants | 8 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 | 1 / 18 |
| other Total, other adverse events | 0 / 14 | 0 / 14 | 0 / 18 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 18 |
Outcome results
Primary
Accrual Rate- Number of Patients Accrued to the Study
The accrual rate will be calculated as the number of patients accrued to the study divided by the number of months of accrual.
Time frame: Time from study opening to study close ~46.42 months
Population: Participants were accrued between July 30 2015 and June 11 2019 for a total of 46.42 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Accrual Rate- Number of Patients Accrued to the Study | 0.30 participants per month |
| Group B | Accrual Rate- Number of Patients Accrued to the Study | 0.30 participants per month |
| Group C | Accrual Rate- Number of Patients Accrued to the Study | 0.39 participants per month |
Primary
Adherence- Amount of Time the Device is Used
Adherence will be calculated as the actual amount of time the device is used divided by the prescribed time. Successful adherence will be defined as use of the device ≥80% of the time assigned.
Time frame: 12 weeks
Population: Adherence data used visits up to withdrawal or study completion. Includes 5 participants missing all breathing visits. Excludes 2 participants that withdrew at baseline and have no available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Adherence- Amount of Time the Device is Used | Weeks 1-6 | 13 Participants |
| Group A | Adherence- Amount of Time the Device is Used | Weeks 7-12 | 10 Participants |
| Group A | Adherence- Amount of Time the Device is Used | Overall | 13 Participants |
| Group B | Adherence- Amount of Time the Device is Used | Weeks 1-6 | 9 Participants |
| Group B | Adherence- Amount of Time the Device is Used | Overall | 8 Participants |
| Group B | Adherence- Amount of Time the Device is Used | Weeks 7-12 | 6 Participants |
| Group C | Adherence- Amount of Time the Device is Used | Overall | 12 Participants |
| Group C | Adherence- Amount of Time the Device is Used | Weeks 7-12 | 11 Participants |
| Group C | Adherence- Amount of Time the Device is Used | Weeks 1-6 | 14 Participants |
Primary
Retention - Number of Participants Who Complete the Final Assessment
Retention will be calculated as the number of participants who complete the final assessment divided by number randomized.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Retention - Number of Participants Who Complete the Final Assessment | 10 Participants |
| Group B | Retention - Number of Participants Who Complete the Final Assessment | 8 Participants |
| Group C | Retention - Number of Participants Who Complete the Final Assessment | 14 Participants |
Secondary
Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS)
To obtain preliminary data on the variability and efficacy of two doses of a device-guided breathing intervention versus a usual breathing control group for reducing anxiety. This is a 14-item self-report measure of cognitive and behavioral symptoms of anxiety and depression; clinically significant symptoms are indicated by a score of greater than or equal to 8 with a range from 0 to 42. Higher scores indicate more anxiety.
Time frame: 12 weeks
Population: All data was utilized.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Group A | Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS) | Change from baseline to 6 weeks | -1.22 score on a scale |
| Group A | Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS) | Change from baseline to 12 weeks | -2.27 score on a scale |
| Group B | Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS) | Change from baseline to 6 weeks | -2.38 score on a scale |
| Group B | Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS) | Change from baseline to 12 weeks | -2.10 score on a scale |
| Group C | Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS) | Change from baseline to 6 weeks | -1.75 score on a scale |
| Group C | Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS) | Change from baseline to 12 weeks | -1.89 score on a scale |
Other Pre-specified
DNA Methylation Levels
DNA methylation levels will be measured To determine if changes in anxiety are associated with methylation
Time frame: 12 weeks
Other Pre-specified
Gene Expression Levels
The DNA methylation and gene expression patterns between the different groups.
Time frame: 12 weeks
Other Pre-specified
Salivary Cortisol Levels
Cortisol levels will be assessed upon awakening, 30 minutes post-awakening, and at bedtime for three consecutive days at baseline and three consecutive days.
Time frame: 12 weeks