This randomized pilot phase II trial studies two doses (low or high) of a device-guided breathing (RESPeRATE) intervention compared to usual breathing in reducing anxiety in early-stage lung cancer survivors. RESPeRATE is a portable device with a respiration sensor and headphones that may help reduce anxiety and may increase relaxation by automatically adjusting melody/tones to the participants' breathing patterns. It is not yet known whether low- or high-doses of the RESPeRATE device is more effective than usual breathing in reducing anxiety in lung cancer survivors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02063828.
PRIMARY OBJECTIVES:
I. To assess feasibility (accrual, participation, adherence, retention) of a randomized study of device-guided breathing in 75 post-treatment early-stage lung cancer survivors with significant anxiety.
II. 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 (primary outcome) and for improving self-reported cancer-related worry, dyspnea and respiratory functioning (secondary outcomes) in post-treatment lung cancer survivors.
III. To select the optimal dose of the device-guided breathing intervention (15 minutes once/day or twice/day) for subsequent randomized study.
IV. To determine if changes in anxiety attributed to device-guided breathing are correlated with epigenetic (deoxyribonucleic acid [DNA] methylation) and/or gene expression changes.
V. To obtain preliminary data on changes in salivary cortisol (diurnal slope, cortisol awakening response, area under the curve) in each intervention group and associations between salivary cortisol and anxiety.
OUTLINE: Participants are randomized to 1 of 3 groups.
GROUP A (LOW-DOSE): Participants use the RESPeRATE device that constantly synchronizes and automatically adjusts the melody/tones to their breathing pattern for 15 minutes once per day (QD) at least 5 days a week for 12 weeks.
GROUP B (HIGH-DOSE): Participants use the RESPeRATE device that constantly synchronizes and automatically adjusts the melody/tones to their breathing pattern for 15 minutes twice per day (BID) at least 5 days a week for 12 weeks.
GROUP C (CONTROL): Participants use the RESPeRATE device with chimes timed to the rate at which they are already breathing for 15 minutes QD at least 5 days a week for 12 weeks.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationWake Forest NCORP Research Base
Principal InvestigatorSuzanne C. Danhauer