Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
46 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-07-30
Study Completion Date
2019-12-23
Brief Summary
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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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Detailed Description
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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.
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.
Conditions
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Lung Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Group A
Group A - Device Guided Breathing Low Dose
Group Type
EXPERIMENTAL
Group A - Device guided breathing low dose
Intervention Type
DEVICE
Group A: 15 minutes once a day, 5 days a week for 12 weeks.
Group B
Group B - Device guided breathing high dose
Group Type
EXPERIMENTAL
Group B - Device guided breathing high dose
Intervention Type
DEVICE
Group B - 15 minutes twice a day, 5 days a week for 12 weeks.
Group C
Group C - Usual Breathing Control Group
Group Type
SHAM_COMPARATOR
Group C - Usual Breathing Control Group
Intervention Type
DEVICE
Group C - 15 minutes per day, 5 days a week for 12 weeks.
Interventions
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Group A - Device guided breathing low dose
Group A: 15 minutes once a day, 5 days a week for 12 weeks.
Intervention Type
DEVICE
Group B - Device guided breathing high dose
Group B - 15 minutes twice a day, 5 days a week for 12 weeks.
Intervention Type
DEVICE
Group C - Usual Breathing Control Group
Group C - 15 minutes per day, 5 days a week for 12 weeks.
Intervention Type
DEVICE
Other Intervention Names
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RESPeRATE (InterCure Ltd) Device
RESPeRATE (InterCure Ltd) Device
RESPeRATE (InterCure Ltd) Device
Eligibility Criteria
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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
* 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).
* 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).
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
Wake Forest University Health Sciences
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Suzanne C Danhauer, PhD
Role: STUDY_CHAIR
Wake Forest University Health Sciences
Glenn Lesser, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Beebe Health Campus
Rehoboth Beach, Delaware, United States
Site Status
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Site Status
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
Site Status
Mercy Hospital
Coon Rapids, Minnesota, United States
Site Status
Fairview Southdale Hospital
Edina, Minnesota, United States
Site Status
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Site Status
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Site Status
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Site Status
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Site Status
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
Site Status
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Site Status
Countries
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United States
References
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Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WF-01213
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2014-02413
Identifier Type: REGISTRY
Identifier Source: secondary_id
IRB00038743
Identifier Type: -
Identifier Source: org_study_id
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