Breathe Anew for Lung Cancer Survivorship (BA)
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Breathe Anew Survivorship Program
Sponsored by
About this trial
This is an interventional other trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older
- All patients at St. Joseph's Healthcare Hamilton who received lung resection for Stage I, Stage II, or Stage IIIa Non-Small Cell Lung Cancer are eligible to enroll.
- Owns a smart device
Exclusion Criteria:
- Patients who received lung resection for Stage IIIb or IV Non-Small Cell Lung Cancer
- Patients with affected mobility (walker, wheelchair)
- Patients who use oxygen at home
Sites / Locations
- St. Joseph's Healthcare Hamilton
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Feasibility
Arm Description
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.
Outcomes
Primary Outcome Measures
Compliance
The feasibility of Breath Anew, as measured by a rate of compliance of >70% with all the components of the intervention.
Secondary Outcome Measures
Accrual Rate
Rate of accrual to the intervention
Patient-Reported Satisfaction
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
Cost per patient for the duration of the intervention
Full Information
NCT ID
NCT03773380
First Posted
December 10, 2018
Last Updated
March 3, 2022
Sponsor
St. Joseph's Healthcare Hamilton
1. Study Identification
Unique Protocol Identification Number
NCT03773380
Brief Title
Breathe Anew for Lung Cancer Survivorship
Acronym
BA
Official Title
Breathe Anew: Designing and Testing the Feasibility of a Novel Intervention for Lung Cancer Survivorship
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Survivorship programs have become an integral component of modern cancer care programs. In Canada, there has been tremendous success for survivorship programs for breast, prostate, and colorectal cancer, however lung cancer survivorship programs have not been widely developed. The complexity of the disease, high mortality, short survival times, high cost of surveillance, and patient habits have traditionally been barriers against the success of lung cancer survivorship programs. The investigator proposes a feasibility study to pilot a novel intervention titled Breathe Anew, which will aim to identify and overcome the barriers to the design and implementation of a lung cancer survivorship program. The investigator has assembled a multi-disciplinary team of experts and lung cancer survivors who will develop the Breathe Anew survivorship intervention. The intervention will be vetted using an integrated knowledge translation approach, which will involve members of the target population, primarily patients who previously underwent lung resection, to modify the intervention and ensure acceptability. After Breathe Anew has been designed, it will be tested in a pilot study of 50 patients to ensure its feasibility and determine its cost. The ultimate goal of this feasibility study is to lay the groundwork for a subsequent comparative trial to evaluate the impact of Breathe Anew on patient-important outcomes including health related quality and length of life and postoperative complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Feasibility
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Breathe Anew Survivorship Program
Other Intervention Name(s)
Wearable Technology, Mindfulness Therapy
Intervention Description
The feasibility will be tested of the Breathe Anew Survivorship Program
Primary Outcome Measure Information:
Title
Compliance
Description
The feasibility of Breath Anew, as measured by a rate of compliance of >70% with all the components of the intervention.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Accrual Rate
Description
Rate of accrual to the intervention
Time Frame
12 months
Title
Patient-Reported Satisfaction
Description
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).
Time Frame
12 months
Title
Cost Per Patient
Description
Cost per patient for the duration of the intervention
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older
All patients at St. Joseph's Healthcare Hamilton who received lung resection for Stage I, Stage II, or Stage IIIa Non-Small Cell Lung Cancer are eligible to enroll.
Owns a smart device
Exclusion Criteria:
Patients who received lung resection for Stage IIIb or IV Non-Small Cell Lung Cancer
Patients with affected mobility (walker, wheelchair)
Patients who use oxygen at home
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Breathe Anew for Lung Cancer Survivorship
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