Reducing Lung Cancer-Related Anxiety (RELAX)

Lung Cancer Clinical Trial

— RELAX  

Official title:

Reducing Lung Cancer-Related Anxiety (RELAX)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02063828
• Other study ID #: IRB00038743
• Secondary ID: U10CA081851WF-01
• Status: Terminated
• Phase: N/A
• Start date: July 30, 2015
• Est. completion date: December 23, 2019

Study information

• Verified date: March 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: December 23, 2019
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Device:
• Group A - Device guided breathing low dose
Group A: 15 minutes once a day, 5 days a week for 12 weeks.
• Group B - Device guided breathing high dose
Group B - 15 minutes twice a day, 5 days a week for 12 weeks.
• Group C - Usual Breathing Control Group
Group C - 15 minutes per day, 5 days a week for 12 weeks.

Locations

Country	Name	City	State
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Prisma Health Greenville Memorial Hospital	Greenville	South Carolina
United States	Margaret R Pardee Memorial Hospital	Hendersonville	North Carolina
United States	Saint John's Hospital - Healtheast	Maplewood	Minnesota
United States	Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Beebe Health Campus	Rehoboth Beach	Delaware
United States	Spartanburg Medical Center	Spartanburg	South Carolina
United States	Cancer Center of Kansas - Wichita	Wichita	Kansas
United States	Cancer Center of Kansas-Wichita Medical Arts Tower	Wichita	Kansas
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Salivary Cortisol Levels	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
Other	DNA Methylation Levels	DNA methylation levels will be measured To determine if changes in anxiety are associated with methylation	12 weeks
Other	Gene Expression Levels	The DNA methylation and gene expression patterns between the different groups.	12 weeks
Primary	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
Primary	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
Primary	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	Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS)	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