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Completed

NCT Number: NCT03773380

Breathe Anew for Lung Cancer Survivorship

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breathe Anew Survivorship Program

Combination Product

The feasibility will be tested of the Breathe Anew Survivorship Program

Other names: Wearable Technology, Mindfulness Therapy

Primary outcomes

  1. Compliance

    Time frame: 12 months

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

Secondary outcomes

  1. Accrual Rate

    Time frame: 12 months

    Rate of accrual to the intervention

  2. Patient-Reported Satisfaction

    Time frame: 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

    Time frame: 12 months

    Cost per patient for the duration of the intervention

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Registry information

Official study title

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

Acronym: BA

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 12, 2018
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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