NCT02063828: RELAX

Reducing Lung Cancer-Related Anxiety (RELAX)

Terminated NA Results posted Last updated 5 March 2021

What this trial tests

NA trial testing Group A - Device guided breathing low dose in Lung Cancer in 46 participants. Terminated before completion.

Timeline

30 July 2015

Primary endpoint
23 December 2019

23 December 2019

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	supportive care
Enrollment	46
Start date	30 July 2015
Primary completion	23 December 2019
Estimated completion	23 December 2019
Sites	11 locations across United States

Drugs / interventions tested

• Group A - Device guided breathing low dose
• Group B - Device guided breathing high dose
• Group C - Usual Breathing Control Group

Conditions studied

• Lung Cancer — all drugs for Lung Cancer →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Retention - Number of Participants Who Complete the Final Assessment Primary · 12 weeks

Retention will be calculated as the number of participants who complete the final assessment divided by number randomized.

Group	Value	95% CI
Group A	10
Group B	8
Group C	14

Adherence- Amount of Time the Device is Used Primary · 12 weeks

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.

Overall

Group	Value	95% CI
Group A	13
Group B	8
Group C	12

Weeks 1-6

Group	Value	95% CI
Group A	13
Group B	9
Group C	14

Weeks 7-12

Group	Value	95% CI
Group A	10
Group B	6
Group C	11

Accrual Rate- Number of Patients Accrued to the Study Primary · Time from study opening to study close ~46.42 months

The accrual rate will be calculated as the number of patients accrued to the study divided by the number of months of accrual.

Group	Value	95% CI
Group A	0.30
Group B	0.30
Group C	0.39

Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS) Secondary · 12 weeks

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.

Change from baseline to 6 weeks

Group	Value	95% CI
Group A	-1.22	-2.90 – 0.45
Group B	-2.38	-4.34 – -0.43
Group C	-1.75	-3.21 – -0.29

Change from baseline to 12 weeks

Group	Value	95% CI
Group A	-2.27	-3.55 – -0.99
Group B	-2.10	-3.74 – -0.45
Group C	-1.89	-3.01 – -0.77

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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).
   Danhauer SC, Dressler EV, Brown WM, Nightingale CL, et al · · 2023 · cited 1× · PMID 37029555 · DOI 10.1177/15347354231164406