Reducing Lung Cancer-Related Anxiety (RELAX)

Wake Forest University (WFU)

Status: Terminated

Conditions: Lung Cancer

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02063828

U10CA081851 (U.S. NIH Grant/Contract)

1UG1CA189824 (U.S. NIH Grant/Contract)

WF-01213 (Other Identifier)

IRB00038743

NCI-2014-02413 (Registry Identifier)

2R25CA122061-07 (U.S. NIH Grant/Contract)

R21CA182111-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 3 patient groups

Group A

Experimental group

Description:

Group A - Device Guided Breathing Low Dose

Treatment:

Device: Group A - Device guided breathing low dose

Group B

Experimental group

Description:

Group B - Device guided breathing high dose

Treatment:

Device: Group B - Device guided breathing high dose

Group C

Sham Comparator group

Description:

Group C - Usual Breathing Control Group

Treatment:

Device: Group C - Usual Breathing Control Group