Breathe Anew for Lung Cancer Survivorship (BA)
|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: NCT03773380|
Recruitment Status : Active, not recruiting
First Posted : December 12, 2018
Last Update Posted : March 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Combination Product: Breathe Anew Survivorship Program||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Breathe Anew: Designing and Testing the Feasibility of a Novel Intervention for Lung Cancer Survivorship|
|Actual Study Start Date :||January 2, 2019|
|Estimated Primary Completion Date :||June 15, 2020|
|Estimated Study Completion Date :||June 15, 2020|
50 patients will be recruited to take part in this feasibility study. They will all undergo this Breathe Anew Program post-surgery. Breathe Anew consists of radiological surveillance, physical rehabilitation using a Fitbit, mindfulness therapy, and referral for symptom management specialists when needed.
Combination Product: Breathe Anew Survivorship Program
The feasibility will be tested of the Breathe Anew Survivorship Program
Other Name: Wearable Technology, Mindfulness Therapy
- Compliance [ Time Frame: 12 months ]The feasibility of Breath Anew, as measured by a rate of compliance of >70% with all the components of the intervention.
- Accrual Rate [ Time Frame: 12 months ]Rate of accrual to the intervention
- Patient-Reported Satisfaction [ Time Frame: 12 months ]Using the EQ-5D-5L, which is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The EQ-5D-5L asks the participant to indicate what best describes their health on the day the scale is administered and it consists of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression which are measured by a severity scale from 1-5 (no problems = 1, slight problems = 2, moderate problems = 3, severe problems = 4, or completely unable to = 5).
- Cost Per Patient [ Time Frame: 12 months ]Cost per patient for the duration of the intervention
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): NCT03773380
|St. Joseph's Healthcare Hamilton|
|Hamilton, Ontario, Canada, L8N 4A6|