Lung Cancer Clinical Trial

Reducing Lung Cancer-Related Anxiety (RELAX)

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.

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Full Description

OBJECTIVES

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.
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.
To select the optimal dose of the device-guided breathing intervention (15 minutes once/day or twice/day) for subsequent randomized study.

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Eligibility Criteria

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).

Study is for people with:

Lung Cancer

Estimated Enrollment:

46

Study ID:

NCT02063828

Recruitment Status:

Terminated

Sponsor:

Wake Forest University Health Sciences

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There are 11 Locations for this study

See Locations Near You

Beebe Health Campus
Rehoboth Beach Delaware, 19971, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas - Wichita
Wichita Kansas, 67214, United States
Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Saint John's Hospital - Healtheast
Maplewood Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Margaret R Pardee Memorial Hospital
Hendersonville North Carolina, 28791, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
Prisma Health Greenville Memorial Hospital
Greenville South Carolina, 29605, United States
Spartanburg Medical Center
Spartanburg South Carolina, 29303, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

46

Study ID:

NCT02063828

Recruitment Status:

Terminated

Sponsor:


Wake Forest University Health Sciences

How clear is this clinincal trial information?

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