Reducing Lung Cancer-Related Anxiety (RELAX)

NCT02063828 | Terminated Results DMC FDA Device

• 7 other identifiers: IRB00038743U10CA081851WF-012131UG1CA1898242R25CA122061-07R21CA182111-01NCI-2014-02413
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 11

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.

Conditions

Lung Cancer

Keywords

anxiety; Dyspnea; respiratory functioning

Outcome Measures

Primary Outcomes (3)

• Retention - Number of Participants Who Complete the Final Assessment

  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

  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

  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 Outcomes (1)

• Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS)

  12 weeks

Other Outcomes (3)

• Salivary Cortisol Levels

  12 weeks

• DNA Methylation Levels

  12 weeks

• Gene Expression Levels

  12 weeks

Study Arms (3)

Group A

EXPERIMENTAL

Group A - Device Guided Breathing Low Dose

Device: Group A - Device guided breathing low dose

Group B

EXPERIMENTAL

Group B - Device guided breathing high dose

Device: Group B - Device guided breathing high dose

Group C

SHAM COMPARATOR

Group C - Usual Breathing Control Group

Device: Group C - Usual Breathing Control Group

Interventions

Group A - Device guided breathing low dose DEVICE

Group A: 15 minutes once a day, 5 days a week for 12 weeks.

Also known as: RESPeRATE (InterCure Ltd) Device

Group A

Group B - Device guided breathing high dose DEVICE

Group B - 15 minutes twice a day, 5 days a week for 12 weeks.

Also known as: RESPeRATE (InterCure Ltd) Device

Group B

Group C - Usual Breathing Control Group DEVICE

Group C - 15 minutes per day, 5 days a week for 12 weeks.

Also known as: RESPeRATE (InterCure Ltd) Device

Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (11)

Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States

Location

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109, United States

Location

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

Location

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MeSH Terms

Conditions

Lung Neoplasms; Anxiety Disorders; Dyspnea

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mental Disorders; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Trial terminated early due to slow accrual.

Results Point of Contact

• Title: Emily Dressler, PhD
• Organization: Wake Forest NCORP Research Base

ncorp@wakehealth.edu

336 716-0891

Study Officials

• Suzanne C Danhauer, PhD

  Wake Forest University Health Sciences

  STUDY CHAIR

• Glenn Lesser, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: February 14, 2014
• Study Start: July 30, 2015
• Primary Completion: December 23, 2019
• Study Completion: December 23, 2019
• Last Updated: March 5, 2021
• Results First Posted: February 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)