Lung cancer is the second-most common cancer diagnosed in the US, yet little "survivorship" research has focused on this population. As the number of early stage lung cancer (ESLC) survivors increases because of uptake in low dose computerized tomography lung cancer screening, it will be increasingly important to develop interventions to improve their well-being. Clinically significant anxiety is reported by 20% to 30% of lung cancer patients and post-treatment survivors. Further, anxiety frequently co-occurs with dyspnea (shortness of breath), which can exacerbate the underlying anxiety. RESPeRATE is an FDA-approved biofeedback device that monitors respiration patterns and gently guides users to reduce their respiration rate and increase their exhalation time. The goal of study is to determine feasibility of this device-guided breathing intervention versus a music control group and to obtain preliminary data on effects on anxiety, dyspnea, pulmonary function, and functional fitness in ESLC survivors. This study will enroll 60 post-treatment ESLC survivors with clinically meaningful anxiety symptoms through two sites of the Wake Forest Community Clinical Oncology Program Research Base (WF CCOP RB): the Comprehensive Cancer Center of Wake Forest University and the Wichita CCOP site). This pilot trial will have three groups: low-dose (15 minutes, once per day) RESPeRATE device-guided breathing (n=20), high-dose (15 minutes, twice per day) RESPeRATE (n=20), and music control (15 minutes, once per day) (n=20). After randomization, each participant will receive a device and appropriate instruction (RESPeRATE or an MP3 player plus home heart rate monitor) and will use the device at home for 8 weeks. Self-reported outcomes (anxiety, dyspnea), pulmonary function testing, and functional fitness assessment (6-minute walk) will be completed at baseline and 8 weeks.
Aim 1 will assess the feasibility (accrual, participation, retention, adherence) of a randomized controlled study comparing device-guided breathing to music in 60 post-treatment ESLC patients with clinically meaningful anxiety symptoms.
Aim 2 will obtain preliminary data regarding the variability and efficacy of two doses of the RESPeRATE intervention compared to a music control group for improving anxiety (primary outcome) and dyspnea, pulmonary function, and functional fitness (secondary outcomes) in post-treatment ESLC patients.
Aim 3 is to select the optimal dose of the device-guided breathing intervention for use in a subsequent, fully- powered randomized control trial. The results of this study will provide outstanding preliminary data for our planned R01 application for a larger randomized controlled trial that will be run through the WF CCOP RB that can better elucidate the impact of the proposed simple intervention for anxious, post-treatment ESLC survivors, that can be easily disseminated.

Public Health Relevance

Anxiety and dyspnea (shortness of breath) are common, co-occurring, and highly distressing symptoms for post-treatment lung cancer survivors. We plan to examine a simple, portable, device-guided breathing intervention called RESPeRATE for improving these symptoms in this survivor group~ this device will be compared to a listening to music control group. The findings of this study will lead to improvements in the treatment of emotional and respiratory symptoms for a rapidly growing population of early-stage lung cancer survivors and have high potential for broad dissemination to community-based cancer survivorship settings.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Exploratory/Developmental Grants (R21)
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Special Emphasis Panel (ZCA1-SRLB-B (O1))
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O'Mara, Ann M
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Wake Forest University Health Sciences
Public Health & Prev Medicine
Schools of Medicine
United States
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