Reducing Lung Cancer-Related Anxiety (RELAX)

Not Applicable

Terminated

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

Brief Summary: 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.

Detailed Description: OBJECTIVES

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

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
Group C	Group C - Usual Breathing Control Group	Group C - Usual Breathing Control Group
Group B	Group B - Device guided breathing high dose	Group B - Device guided breathing high dose
Group A	Group A - Device guided breathing low dose	Group A - Device Guided Breathing Low Dose

Primary Outcome Measures

Name	Time	Method
Accrual Rate- Number of Patients Accrued to the Study	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.
Retention - Number of Participants Who Complete the Final Assessment	12 weeks	Retention will be calculated as the number of participants who complete the final assessment divided by number randomized.
Adherence- Amount of Time the Device is Used	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS)	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.

Locations (11): Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States
Mercy Hospital
🇺🇸
Coon Rapids, Minnesota, United States
Cancer Center of Kansas - Wichita
🇺🇸
Wichita, Kansas, United States
Beebe Health Campus
🇺🇸
Rehoboth Beach, Delaware, United States
Fairview Southdale Hospital
🇺🇸
Edina, Minnesota, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
🇺🇸
Wichita, Kansas, United States
Saint John's Hospital - Healtheast
🇺🇸
Maplewood, Minnesota, United States
Margaret R Pardee Memorial Hospital
🇺🇸
Hendersonville, North Carolina, United States
Abbott-Northwestern Hospital
🇺🇸
Minneapolis, Minnesota, United States
Prisma Health Greenville Memorial Hospital
🇺🇸
Greenville, South Carolina, United States
Spartanburg Medical Center
🇺🇸
Spartanburg, South Carolina, United States