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BA: Breathe Anew for Lung Cancer Survivorship

Sponsor
St. Joseph's Healthcare Hamilton (Other)
Overall Status
Completed
CT.gov ID
NCT03773380
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
36
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Breathe Anew Survivorship Program
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Breathe Anew: Designing and Testing the Feasibility of a Novel Intervention for Lung Cancer Survivorship
Actual Study Start Date :
Jan 2, 2019
Actual Primary Completion Date :
Jan 1, 2022
Actual Study Completion Date :
Jan 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Feasibility

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 Names:
  • Wearable Technology, Mindfulness Therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Compliance [12 months]

      The feasibility of Breath Anew, as measured by a rate of compliance of >70% with all the components of the intervention.

    Secondary Outcome Measures

    1. Accrual Rate [12 months]

      Rate of accrual to the intervention

    2. Patient-Reported Satisfaction [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).

    3. Cost Per Patient [12 months]

      Cost per patient for the duration of the intervention

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Joseph's Healthcare Hamilton Hamilton Ontario Canada L8N 4A6

    Sponsors and Collaborators

    • St. Joseph's Healthcare Hamilton

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wael Hanna, Associate Professor of Surgery, St. Joseph's Healthcare Hamilton
    ClinicalTrials.gov Identifier:
    NCT03773380
    Other Study ID Numbers:
    • SJHH-BA
    First Posted:
    Dec 12, 2018
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Mar 4, 2022