Trial Outcomes & Findings for Reducing Lung Cancer-Related Anxiety (RELAX) (NCT NCT02063828)
NCT ID: NCT02063828
Last Updated: 2021-03-05
Results Overview
Retention will be calculated as the number of participants who complete the final assessment divided by number randomized.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-03-05
Participant Flow
Implementation was facilitated through the Wake Forest National Cancer Institute Community Oncology Research Program (NCORP), developed to increase community participation in cancer trials. Forty-six participants were accrued between July 30 2015 and June 11 2019 (0.99 participants/month).
In this feasibility study, participants were stratified by baseline self-reported dyspnea score and randomized to a 12-week high-dose or low-dose device-guided breathing intervention versus a usual breathing control group with equal probability, using variable length permuted block randomization. All participants enrolled were randomized and included in analyses.
Participant milestones
| Measure |
Group C - Usual Breathing Control Group. 15 Minutes Per Day, 5 Days a Week for 12 Weeks.
Group C - Usual Breathing Control Group
Group C - Usual Breathing Control Group: Group C - 15 minutes per day, 5 days a week for 12 weeks.
|
Group A - Device Guided Breathing Low Dose. 15 Minutes Once a Day, 5 Days a Week for 12 Weeks.
Group A - Device Guided Breathing Low Dose
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. 15 Minutes Twice a Day, 5 Days a Week for 12 Weeks.
Group B - Device guided breathing high dose
Group B - Device guided breathing high dose: Group B - 15 minutes twice a day, 5 days a week for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
14
|
14
|
|
Overall Study
Week 6
|
14
|
11
|
9
|
|
Overall Study
COMPLETED
|
14
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
6
|
Reasons for withdrawal
| Measure |
Group C - Usual Breathing Control Group. 15 Minutes Per Day, 5 Days a Week for 12 Weeks.
Group C - Usual Breathing Control Group
Group C - Usual Breathing Control Group: Group C - 15 minutes per day, 5 days a week for 12 weeks.
|
Group A - Device Guided Breathing Low Dose. 15 Minutes Once a Day, 5 Days a Week for 12 Weeks.
Group A - Device Guided Breathing Low Dose
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. 15 Minutes Twice a Day, 5 Days a Week for 12 Weeks.
Group B - Device guided breathing high dose
Group B - Device guided breathing high dose: Group B - 15 minutes twice a day, 5 days a week for 12 weeks.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
6
|
|
Overall Study
Death
|
1
|
0
|
0
|
Baseline Characteristics
Reducing Lung Cancer-Related Anxiety (RELAX)
Baseline characteristics by cohort
| Measure |
Group A
n=14 Participants
Group A - Device Guided Breathing Low Dose
Group A - Device guided breathing low dose: Group A: 15 minutes once a day, 5 days a week for 12 weeks.
|
Group B
n=14 Participants
Group B - Device guided breathing high dose
Group B - Device guided breathing high dose: Group B - 15 minutes twice a day, 5 days a week for 12 weeks.
|
Group C
n=18 Participants
Group C - Usual Breathing Control Group
Group C - Usual Breathing Control Group: Group C - 15 minutes per day, 5 days a week for 12 weeks.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63 years
n=99 Participants
|
64 years
n=107 Participants
|
66 years
n=206 Participants
|
65 years
n=7 Participants
|
|
Age, Customized
Age · >=50 years
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
|
Age, Customized
Age · <50
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=99 Participants
|
14 participants
n=107 Participants
|
18 participants
n=206 Participants
|
46 participants
n=7 Participants
|
|
Cancer Dyspnea Scale
<8
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Cancer Dyspnea Scale
>=8
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
|
Marital Status
Single
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Marital Status
Married
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Marital Status
Separated/Divorced/Widowed
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Marital Status
Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Income
Under $20,000
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Income
$20,000 - $49,999
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Income
$50,000 or more
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Income
Unknown
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Education
High School or Less
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Education
College graduate or some college
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
|
Education
Post College Graduate Education
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Stage of Disease
I
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Stage of Disease
II
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Stage of Disease
III
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Stage of Disease
IV
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Current Smoker
Yes
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Current Smoker
No
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 12 weeksRetention will be calculated as the number of participants who complete the final assessment divided by number randomized.
Outcome measures
| Measure |
Group A
n=14 Participants
Group A - Device Guided Breathing Low Dose
Group A - Device guided breathing low dose: Group A: 15 minutes once a day, 5 days a week for 12 weeks.
|
Group B
n=14 Participants
Group B - Device guided breathing high dose
Group B - Device guided breathing high dose: Group B - 15 minutes twice a day, 5 days a week for 12 weeks.
|
Group C
n=18 Participants
Group C - Usual Breathing Control Group
Group C - Usual Breathing Control Group: Group C - 15 minutes per day, 5 days a week for 12 weeks.
|
|---|---|---|---|
|
Retention - Number of Participants Who Complete the Final Assessment
|
10 Participants
|
8 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Adherence data used visits up to withdrawal or study completion. Includes 5 participants missing all breathing visits. Excludes 2 participants that withdrew at baseline and have no available data.
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.
Outcome measures
| Measure |
Group A
n=13 Participants
Group A - Device Guided Breathing Low Dose
Group A - Device guided breathing low dose: Group A: 15 minutes once a day, 5 days a week for 12 weeks.
|
Group B
n=13 Participants
Group B - Device guided breathing high dose
Group B - Device guided breathing high dose: Group B - 15 minutes twice a day, 5 days a week for 12 weeks.
|
Group C
n=18 Participants
Group C - Usual Breathing Control Group
Group C - Usual Breathing Control Group: Group C - 15 minutes per day, 5 days a week for 12 weeks.
|
|---|---|---|---|
|
Adherence- Amount of Time the Device is Used
Overall
|
13 Participants
|
8 Participants
|
12 Participants
|
|
Adherence- Amount of Time the Device is Used
Weeks 1-6
|
13 Participants
|
9 Participants
|
14 Participants
|
|
Adherence- Amount of Time the Device is Used
Weeks 7-12
|
10 Participants
|
6 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Time from study opening to study close ~46.42 monthsPopulation: Participants were accrued between July 30 2015 and June 11 2019 for a total of 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.
Outcome measures
| Measure |
Group A
n=14 Participants
Group A - Device Guided Breathing Low Dose
Group A - Device guided breathing low dose: Group A: 15 minutes once a day, 5 days a week for 12 weeks.
|
Group B
n=14 Participants
Group B - Device guided breathing high dose
Group B - Device guided breathing high dose: Group B - 15 minutes twice a day, 5 days a week for 12 weeks.
|
Group C
n=18 Participants
Group C - Usual Breathing Control Group
Group C - Usual Breathing Control Group: Group C - 15 minutes per day, 5 days a week for 12 weeks.
|
|---|---|---|---|
|
Accrual Rate- Number of Patients Accrued to the Study
|
0.30 participants per month
|
0.30 participants per month
|
0.39 participants per month
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All data was utilized.
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.
Outcome measures
| Measure |
Group A
n=14 Participants
Group A - Device Guided Breathing Low Dose
Group A - Device guided breathing low dose: Group A: 15 minutes once a day, 5 days a week for 12 weeks.
|
Group B
n=14 Participants
Group B - Device guided breathing high dose
Group B - Device guided breathing high dose: Group B - 15 minutes twice a day, 5 days a week for 12 weeks.
|
Group C
n=18 Participants
Group C - Usual Breathing Control Group
Group C - Usual Breathing Control Group: Group C - 15 minutes per day, 5 days a week for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS)
Change from baseline to 6 weeks
|
-1.22 score on a scale
Interval -2.9 to 0.45
|
-2.38 score on a scale
Interval -4.34 to -0.43
|
-1.75 score on a scale
Interval -3.21 to -0.29
|
|
Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS)
Change from baseline to 12 weeks
|
-2.27 score on a scale
Interval -3.55 to -0.99
|
-2.10 score on a scale
Interval -3.74 to -0.45
|
-1.89 score on a scale
Interval -3.01 to -0.77
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksCortisol levels will be assessed upon awakening, 30 minutes post-awakening, and at bedtime for three consecutive days at baseline and three consecutive days.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksDNA methylation levels will be measured To determine if changes in anxiety are associated with methylation
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksThe DNA methylation and gene expression patterns between the different groups.
Outcome measures
Outcome data not reported
Adverse Events
Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place