Reducing Lung Cancer-Related Anxiety (RELAX)
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Mar 5, 2021 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Supportive Care
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Wake Forest University Health Sciences
- Interventions being studied
- Device: Group A - Device guided breathing low dose; Device: Group B - Device guided breathing high dose; Device: Group C - Usual Breathing Control Group
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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).
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Beebe Health CampusRehoboth Beach, Delaware
- Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas
- Cancer Center of Kansas - WichitaWichita, Kansas
- Mercy HospitalCoon Rapids, Minnesota
- Fairview Southdale HospitalEdina, Minnesota
- Saint John's Hospital - HealtheastMaplewood, Minnesota
- Abbott-Northwestern HospitalMinneapolis, Minnesota
- Margaret R Pardee Memorial HospitalHendersonville, North Carolina
- Wake Forest University Health SciencesWinston-Salem, North Carolina
- Prisma Health Greenville Memorial HospitalGreenville, South Carolina
- Spartanburg Medical CenterSpartanburg, South Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 5, 2021. Always confirm current availability with the study team.