Reducing Lung Cancer-Related Anxiety (RELAX)

Study Overview
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Brief Summary
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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
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OBJECTIVES 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. 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. To select the optimal dose of the device-guided breathing intervention (15 minutes once/day or twice/day) for subsequent randomized study.

Official Title
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Reducing Lung Cancer-Related Anxiety (RELAX)

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Group A - Device guided breathing low dose
* Device: Group B - Device guided breathing high dose
* Device: Group C - Usual Breathing Control Group


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Group A - Device Guided Breathing Low Dose | Device: Group A - Device guided breathing low dose<br>* Group A: 15 minutes once a day, 5 days a week for 12 weeks.<br>* Other names: RESPeRATE (InterCure Ltd) Device;|
| Experimental: Group B<br>Group B - Device guided breathing high dose | Device: Group B - Device guided breathing high dose<br>* Group B - 15 minutes twice a day, 5 days a week for 12 weeks.<br>* Other names: RESPeRATE (InterCure Ltd) Device;|
| Sham Comparator: Group C<br>Group C - Usual Breathing Control Group | Device: Group C - Usual Breathing Control Group<br>* Group C - 15 minutes per day, 5 days a week for 12 weeks.<br>* Other names: RESPeRATE (InterCure Ltd) Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| 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. | 12 weeks | 
| 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 from study opening to study close  46.42 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, Dyspnea, respiratory functioning