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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 : 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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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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.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Lung Cancer

Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. DNA Methylation Levels [ Time Frame: 12 weeks ]
    DNA methylation levels will be measured To determine if changes in anxiety are associated with methylation

  3. Gene Expression Levels [ Time Frame: 12 weeks ]
    The DNA methylation and gene expression patterns between the different groups.


Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
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
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Study Chair: Suzanne C Danhauer, PhD Wake Forest University Health Sciences
Principal Investigator: Glenn Lesser, MD Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
Study Protocol and Statistical Analysis Plan  [PDF] October 12, 2018
Informed Consent Form  [PDF] October 12, 2018

More Information
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Publications:
Jacobsen PB DKSZetal. Management of anxiety and depression in adult cancer patients: Toward an evidence-based approach. In: Chang AE GPHDea, editor. Oncology: An Evidence-Based Approach. Philadelphia, PA: Springer; 2006. p. 1552-79.
Stanton AL, Bower JE, Low CA. Posttraumatic Growth After Cancer. In 2006. p. 138-75.
Eisen AR, Rapee RM, Barlow DH. The effects of breathing rate and pCO2 levels on relaxation and anxiety in a non-clinical population. Journal of Anxiety Disorders 1990;4(3):183-90
Hazlett-Stevens H, Craske MG. BREATHING RETRAINING AND DIAPHRAGMATIC BREATHING. In General principles and empirically supported techniques of cognitive behavior therapy. 2009.
Hewitt M, Greenfield S, Stovall E. From cancer patient to cancer survivor: Lost in Transition. 2006. National Academies Press.
Stamm BH, Piland NF, Lambert D, Speck NC. A Rural Perspective on Health Care for the Whole Person. Professional Psychology: Research and Practice 2007;38(3):298-304
American Psychological Association, Practice Directorate, Office of Rural Health (2002a). Caring for the rural community: 2000-2001 report. Washington, DC: APA Press; 2001.
Cancer of the Lung and Bronchus - SEER Stat Fact Sheets [Internet]. [cited 2012 Jul 17]. Available from: http://seer.cancer.gov/statfacts/html/lungb.html
Wilson EB. Probable inference, the law of succession, and statistical inference. JASA1927;22: 209-212.
Garcia SF, George J, Rosenbloom SK, Cella D. Adapting chronic illness health related quality of life item banks for cancer populations. In Poster presented at the International Society for Quality of LifeResearch on Patient-Reported Outcomes in Clinical Practice, Budapest, Hungary. In 2007.
Aldwin, C M, The physiology of stress, in Stress, Coping, and Development Guilford Press: New York, NY. 2007; 39-54.

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02063828    
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 )
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

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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
Keywords provided by Wake Forest University Health Sciences:
anxiety
Dyspnea
respiratory functioning
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases