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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
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung Cancer

Eligibility Criteria

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

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

First Posted
December 10, 2018
Last Updated
March 3, 2022
Sponsor
St. Joseph's Healthcare Hamilton
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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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