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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 : Completed
First Posted : February 14, 2014
Last Update Posted : May 19, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE January 27, 2014
First Posted Date  ICMJE February 14, 2014
Last Update Posted Date May 19, 2020
Actual Study Start Date  ICMJE July 30, 2015
Actual Primary Completion Date December 23, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
  • Participation Rate [ Time Frame: 12 weeks ]
    The participation rate will be calculated as the proportion of eligible patients who agree to participate
  • Accrual Rate- number of patients accrued to the study [ Time Frame: 12 weeks ]
    The accrual rate will be calculated as the number of patients accrued to the study divided by the number of months of accrual.
  • 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 ≥75% of the time assigned.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2014)
Change from baseline HADS- Anxiety Assessed 4 weeks post-randomization [ Time Frame: 4 weeks ]
The clinical endpoints are anxiety (primary outcome: HADS-Anxiety), dyspnea, and respiratory function at baseline and 4 weeks post-randomization.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2014)
Change from 4 weeks HADS-Anxiety at 8 weeks [ Time Frame: 8 weeks ]
The clinical endpoints are anxiety (primary outcome: HADS-Anxiety), dyspnea, and respiratory function at 8 weeks post-randomization.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Lung Cancer-Related Anxiety (RELAX)
Official Title  ICMJE Reducing Lung Cancer-Related Anxiety (RELAX)
Brief 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.
Detailed Description

OBJECTIVES

  1. To assess feasibility (accrual, participation, adherence, retention) of a randomized study of device-guided breathing and music in 75 post-treatment ESLC 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • 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 Device
  • 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 Device
  • Device: Group C - Usual Breathing Control Group
    Group C - 15 minutes per day, 5 days a week for 12 weeks.
    Other Name: Resperate Device
Study Arms  ICMJE
  • Experimental: Group A
    Group A - Device Guided Breathing Low Dose
    Intervention: Device: Group A - Device guided breathing low dose
  • Active Comparator: Group B
    Group B - Device guided breathing high dose
    Intervention: Device: Group B - Device guided breathing high dose
  • Active Comparator: Group C
    Group C - Usual Breathing Control Group
    Intervention: Device: Group C - Usual Breathing Control Group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2019)
46
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2014)
75
Actual Study Completion Date  ICMJE December 23, 2019
Actual Primary Completion Date December 23, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02063828
Other Study ID Numbers  ICMJE IRB00038743
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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Suzanne C Danhauer, PhD Wake Forest University Health Sciences
Principal Investigator: Glenn Lesser, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP