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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
46
Group A: 15 minutes once a day, 5 days a week for 12 weeks.
Group B - 15 minutes twice a day, 5 days a week for 12 weeks.
Group C - 15 minutes per day, 5 days a week for 12 weeks.
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
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
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
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
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
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Mercy Hospital
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Abbott-Northwestern Hospital
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Margaret R Pardee Memorial Hospital
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Wake Forest University Health Sciences
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