Breathe Anew for Lung Cancer Survivorship

Lung Cancer Clinical Trial

— BA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03773380
• Other study ID #: SJHH-BA
• Status: Completed
• Phase: Phase 1
• Start date: January 2, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: March 2022
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Combination Product:
• Breathe Anew Survivorship Program
The feasibility will be tested of the Breathe Anew Survivorship Program

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance	The feasibility of Breath Anew, as measured by a rate of compliance of >70% with all the components of the intervention.	12 months
Secondary	Accrual Rate	Rate of accrual to the intervention	12 months
Secondary	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).	12 months
Secondary	Cost Per Patient	Cost per patient for the duration of the intervention	12 months