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Breathe Anew for Lung Cancer Survivorship

Breathe Anew: Designing and Testing the Feasibility of a Novel Intervention for Lung Cancer Survivorship

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03773380
Acronym
BA
Enrollment
50
Registered
2018-12-12
Start date
2019-01-02
Completion date
2022-01-01
Last updated
2022-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Interventions

COMBINATION_PRODUCTBreathe Anew Survivorship Program

The feasibility will be tested of the Breathe Anew Survivorship Program

Sponsors

St. Joseph's Healthcare Hamilton
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Compliance12 monthsThe feasibility of Breath Anew, as measured by a rate of compliance of \>70% with all the components of the intervention.

Secondary

MeasureTime frameDescription
Accrual Rate12 monthsRate of accrual to the intervention
Patient-Reported Satisfaction12 monthsUsing 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 Patient12 monthsCost per patient for the duration of the intervention

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026