Reducing Lung Cancer-Related Anxiety (RELAX) (RELAX)

March 3, 2021 updated by: Wake Forest University Health Sciences
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Rehoboth Beach, Delaware, United States, 19971
        • Beebe Health Campus
    • Kansas
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas - Wichita
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
    • North Carolina
      • Hendersonville, North Carolina, United States, 28791
        • Margaret R Pardee Memorial Hospital
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Greenville Memorial Hospital
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • RESPeRATE (InterCure Ltd) Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 weeks
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.
Time from study opening to study close ~46.42 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
DNA Methylation Levels
Time Frame: 12 weeks
DNA methylation levels will be measured To determine if changes in anxiety are associated with methylation
12 weeks
Gene Expression Levels
Time Frame: 12 weeks
The DNA methylation and gene expression patterns between the different groups.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Suzanne C Danhauer, PhD, Wake Forest University Health Sciences
  • Principal Investigator: Glenn Lesser, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2015

Primary Completion (Actual)

December 23, 2019

Study Completion (Actual)

December 23, 2019

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

February 10, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Actual)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 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)
  • NCI-2014-02413 (Registry Identifier: NCI CTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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