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

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group A - Device guided breathing low dose
Group B - Device guided breathing high dose
Group C - Usual Breathing Control Group
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring anxiety, Dyspnea, respiratory functioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Beebe Health Campus
  • Cancer Center of Kansas-Wichita Medical Arts Tower
  • Cancer Center of Kansas - Wichita
  • Mercy Hospital
  • Fairview Southdale Hospital
  • Saint John's Hospital - Healtheast
  • Abbott-Northwestern Hospital
  • Margaret R Pardee Memorial Hospital
  • Wake Forest University Health Sciences
  • Prisma Health Greenville Memorial Hospital
  • Spartanburg Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Group A

Group B

Group C

Arm Description

Group A - Device Guided Breathing Low Dose

Group B - Device guided breathing high dose

Group C - Usual Breathing Control Group

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 27, 2014
Last Updated
March 3, 2021
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02063828
Brief Title
Reducing Lung Cancer-Related Anxiety (RELAX)
Acronym
RELAX
Official Title
Reducing Lung Cancer-Related Anxiety (RELAX)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Took too long to accrue participants, stopped for feasibility concerns
Study Start Date
July 30, 2015 (Actual)
Primary Completion Date
December 23, 2019 (Actual)
Study Completion Date
December 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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 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. 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. To select the optimal dose of the device-guided breathing intervention (15 minutes once/day or twice/day) for subsequent randomized study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
anxiety, Dyspnea, respiratory functioning

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Group A - Device Guided Breathing Low Dose
Arm Title
Group B
Arm Type
Experimental
Arm Description
Group B - Device guided breathing high dose
Arm Title
Group C
Arm Type
Sham Comparator
Arm Description
Group C - Usual Breathing Control Group
Intervention Type
Device
Intervention Name(s)
Group A - Device guided breathing low dose
Other Intervention Name(s)
RESPeRATE (InterCure Ltd) Device
Intervention Description
Group A: 15 minutes once a day, 5 days a week for 12 weeks.
Intervention Type
Device
Intervention Name(s)
Group B - Device guided breathing high dose
Other Intervention Name(s)
RESPeRATE (InterCure Ltd) Device
Intervention Description
Group B - 15 minutes twice a day, 5 days a week for 12 weeks.
Intervention Type
Device
Intervention Name(s)
Group C - Usual Breathing Control Group
Other Intervention Name(s)
RESPeRATE (InterCure Ltd) Device
Intervention Description
Group C - 15 minutes per day, 5 days a week for 12 weeks.
Primary Outcome Measure Information:
Title
Retention - Number of Participants Who Complete the Final Assessment
Description
Retention will be calculated as the number of participants who complete the final assessment divided by number randomized.
Time Frame
12 weeks
Title
Adherence- Amount of Time the Device is Used
Description
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.
Time Frame
12 weeks
Title
Accrual Rate- Number of Patients Accrued to the Study
Description
The accrual rate will be calculated as the number of patients accrued to the study divided by the number of months of accrual.
Time Frame
Time from study opening to study close ~46.42 months
Secondary Outcome Measure Information:
Title
Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Salivary Cortisol Levels
Description
Cortisol levels will be assessed upon awakening, 30 minutes post-awakening, and at bedtime for three consecutive days at baseline and three consecutive days.
Time Frame
12 weeks
Title
DNA Methylation Levels
Description
DNA methylation levels will be measured To determine if changes in anxiety are associated with methylation
Time Frame
12 weeks
Title
Gene Expression Levels
Description
The DNA methylation and gene expression patterns between the different groups.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne C Danhauer, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Glenn Lesser, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beebe Health Campus
City
Rehoboth Beach
State/Province
Delaware
ZIP/Postal Code
19971
Country
United States
Facility Name
Cancer Center of Kansas-Wichita Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Saint John's Hospital - Healtheast
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Abbott-Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Margaret R Pardee Memorial Hospital
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28791
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Prisma Health Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Spartanburg Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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