Reducing Lung Cancer-Related Anxiety (RELAX) (RELAX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02063828|
Recruitment Status : Terminated (Took too long to accrue participants, stopped for feasibility concerns)
First Posted : February 14, 2014
Results First Posted : February 18, 2021
Last Update Posted : March 5, 2021
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Device: Group A - Device guided breathing low dose Device: Group B - Device guided breathing high dose Device: Group C - Usual Breathing Control Group||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Reducing Lung Cancer-Related Anxiety (RELAX)|
|Actual Study Start Date :||July 30, 2015|
|Actual Primary Completion Date :||December 23, 2019|
|Actual Study Completion Date :||December 23, 2019|
Experimental: Group A
Group A - Device Guided Breathing Low Dose
Device: Group A - Device guided breathing low dose
Group A: 15 minutes once a day, 5 days a week for 12 weeks.
Other Name: RESPeRATE (InterCure Ltd) Device
Experimental: Group B
Group B - Device guided breathing high dose
Device: Group B - Device guided breathing high dose
Group B - 15 minutes twice a day, 5 days a week for 12 weeks.
Other Name: RESPeRATE (InterCure Ltd) Device
Sham Comparator: Group C
Group C - Usual Breathing Control Group
Device: Group C - Usual Breathing Control Group
Group C - 15 minutes per day, 5 days a week for 12 weeks.
Other Name: RESPeRATE (InterCure Ltd) Device
- Retention - Number of Participants Who Complete the Final Assessment [ Time Frame: 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 [ Time Frame: 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.
- Accrual Rate- Number of Patients Accrued to the Study [ Time Frame: 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.
- Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 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.
- Salivary Cortisol Levels [ Time Frame: 12 weeks ]Cortisol levels will be assessed upon awakening, 30 minutes post-awakening, and at bedtime for three consecutive days at baseline and three consecutive days.
- DNA Methylation Levels [ Time Frame: 12 weeks ]DNA methylation levels will be measured To determine if changes in anxiety are associated with methylation
- Gene Expression Levels [ Time Frame: 12 weeks ]The DNA methylation and gene expression patterns between the different groups.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063828
|United States, Delaware|
|Beebe Health Campus|
|Rehoboth Beach, Delaware, United States, 19971|
|United States, Kansas|
|Cancer Center of Kansas-Wichita Medical Arts Tower|
|Wichita, Kansas, United States, 67208|
|Cancer Center of Kansas - Wichita|
|Wichita, Kansas, United States, 67214|
|United States, Minnesota|
|Coon Rapids, Minnesota, United States, 55433|
|Fairview Southdale Hospital|
|Edina, Minnesota, United States, 55435|
|Saint John's Hospital - Healtheast|
|Maplewood, Minnesota, United States, 55109|
|Minneapolis, Minnesota, United States, 55407|
|United States, North Carolina|
|Margaret R Pardee Memorial Hospital|
|Hendersonville, North Carolina, United States, 28791|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|United States, South Carolina|
|Prisma Health Greenville Memorial Hospital|
|Greenville, South Carolina, United States, 29605|
|Spartanburg Medical Center|
|Spartanburg, South Carolina, United States, 29303|
|Study Chair:||Suzanne C Danhauer, PhD||Wake Forest University Health Sciences|
|Principal Investigator:||Glenn Lesser, MD||Wake Forest University Health Sciences|
Documents provided by Wake Forest University Health Sciences:
|Responsible Party:||Wake Forest University Health Sciences|
|Other Study ID Numbers:||
U10CA081851 ( U.S. NIH Grant/Contract )
WF-01213 ( Other Identifier: NCI )
1UG1CA189824 ( U.S. NIH Grant/Contract )
2R25CA122061-07 ( U.S. NIH Grant/Contract )
R21CA182111-01 ( U.S. NIH Grant/Contract )
NCI-2014-02413 ( Registry Identifier: NCI CTRP )
|First Posted:||February 14, 2014 Key Record Dates|
|Results First Posted:||February 18, 2021|
|Last Update Posted:||March 5, 2021|
|Last Verified:||March 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Product Manufactured in and Exported from the U.S.:||No|
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases