Reducing Anxiety and Dyspnea via Device-Guided Breathing (RELAX): A Multi-Site Feasibility Study in Post-Treatment Lung Cancer Survivors at Community Cancer Clinics (WF-01213).

INTRODUCTION: Anxiety and dyspnea are 2 common symptoms for lung cancer survivors. Although research suggests decreasing respiration rate can reduce anxiety in several populations, potential benefits of device-guided breathing have not been studied in lung cancer survivors. This feasibility study (WF-01213) provides estimates of accrual, adherence, retention, and preliminary efficacy of 2 doses of a device-guided breathing intervention versus a usual breathing control group for improving self-reported anxiety and dyspnea in post-treatment lung cancer survivors. METHODS: Stage I-IV lung cancer survivors were recruited through the NCI Community Oncology Research Program (NCORP) and randomized to 12 weeks of a device-guided breathing intervention (high dose vs. low dose) or control device. Self-reported outcomes (anxiety, depression, dyspnea, cancer-related worry, fatigue) were assessed at baseline, mid-intervention (Week-6), and post-intervention (Week-12). RESULTS: Forty-six participants (ages 41-77, median = 65; 78% White) were randomized to the high-dose intervention (n = 14), low-dose intervention (n = 14), or control (n = 18) groups between July 2015 and September 2019. Study accrual rate was 0.92 per month for 50 months (projected accrual was 6.3/month). Fourteen participants (30%) withdrew early from the study, with almost half of those discontinuing at or immediately following baseline assessment. No participants were adherent with the intervention per protocol specifications. The proportion minimally adherent (using device at least 1x/week) was 43% (6/14), 64% (9/14), and 61% (11/18) for high-dose, low-dose, and control groups, respectively. Anxiety significantly decreased from baseline for all groups at Week 12. Adherence to the intervention was low across all treatment groups. CONCLUSIONS: This study did not establish feasibility of a community-based randomized trial of 2 doses of device-guided breathing and a control group using an identical-looking device for lung cancer survivors. In both the high-dose and control groups, there were significant improvements from baseline for anxiety and dyspnea. In the low-dose group, there were significant improvements from baseline for anxiety and depression. Ratings and feedback on the intervention were mixed (although leaned in a positive direction). Participants reported liking the feeling of relaxation/calm, helping others, breathing awareness, and music. Participants reporting liking least finding/making time to use the device, frustration with the device, and completing study forms. TRIAL REGISTRATION: CLINICAL TRIALS ID: NCT02063828, clinicaltrials.gov.

The impact of music interventions on anxiety for adult cancer patients: a meta-analysis and systematic review.

INTRODUCTION: Listening to music can positively benefit neurophysiological and emotional responses as well as promote relaxation, which may be especially beneficial for cancer patients undergoing painful and anxiety inducing treatments. The purpose of the present study was to conduct an evidenced-based systematic review and meta-analysis of randomized controlled trials of music interventions to reduce anxiety for adult cancer patients undergoing medical treatment. METHODS: A systematic literature search was conducted and data were abstracted from all eligible studies. Studies were included if they tested a music therapy randomized controlled trial in adult cancer patients (in active treatment), assessed anxiety postintervention using a validated measure, were published in English (or were translatable), and accessible in full text. Studies were qualitatively reviewed by the first author and 2 raters independently assessed each study using the PEDro scale. Standardized mean differences between experimental and control groups were calculated for studies meeting a specified methodological rigor score with accessible means and standard deviations postintervention. Heterogeneity and publication bias were explored. RESULTS: Thirteen randomized controlled trials were included with 4 eligible for meta-analysis. Studies varied in intervention methodology and utilization of anxiety measures. Almost all studies reported either a significant difference in anxiety between groups postintervention or a significant decrease in anxiety over time in the music intervention group. Meta-analytic results of 4 studies (4/13) demonstrated that differences in anxiety between experimental and control groups were not significant in the main analysis or subgroup analysis. Studies demonstrated heterogeneity in anxiety results. Publication bias was not evident. CONCLUSION: The meta-analytic results failed to demonstrate a positive effect on anxiety among adult cancer patients in treatment but may in part be attributed to the small sample size. These findings are in contrast to a prior meta-analysis that analyzed all studies regardless of methodological rigor. More research is needed to ascertain the most optimal intervention methodology and which cancer populations or treatment modalities are appropriate for such an intervention.