Reducing Lung Cancer-Related Anxiety (RELAX)

OBJECTIVES

1. To assess feasibility (accrual, participation, adherence, retention) of a randomized
study of device-guided breathing and music in 75 post-treatment ESLC 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.

Inclusion Criteria:

- Past History of any lung cancer

- For Stage I-III disease, patients should be 2-24 months post-completion of surgery,
radiation therapy and/or chemotherapy with no further planned treatment during the
12-week study and no evidence of disease.

- For Stage IV disease, patients may be receiving no treatment or may be receiving
maintenance treatment with a target agent, chemotherapy, or immunotherapy provided the
most recent imaging does not demonstrate progressive disease.

- After completion of all three screening questionnaires, participant must score
accordingly on at least one questionnaire to be eligible.

- Willing/able to attend brief introductory session and use assigned device for the
assigned period of time (15 minutes once or twice per day), at least 5 days per week
for 12 weeks

- Age ≥ 18 years

- Must have telephone

Exclusion Criteria:

- Patient does not understand English

- Active lung infection

- Progressive cancer (must be considered no evidence of disease or stable)

- Any change in psychotropic medications in past 30 days

- Hearing loss that would preclude participating in interventions. Adequate hearing to
participate will be determined via: (1) Response of "no" to the question ["Do you have
a hearing problem now?"] Participants with hearing aids will be allowed to enroll as
long as their hearing is adequate to hear the sounds on the study devices. If
necessary, potential study participants will receive a brief test trial with the
RESPeRATE device. If they indicate inability to hear the guiding tones, they will not
be enrolled in the study.

Cortisol Exclusion

- Participants with endocrine disorders (e.g., diabetes and thyroid disorders) or on
steroid-based medications are excluded from the cortisol portion of the study (with the
exception of topical hydrocortisone that is permitted).