Breathe Anew for Lung Cancer Survivorship

NCT03773380 | Completed Phase 1

• 1 other identifier: SJHH-BA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Accrual Rate

  12 months

• Patient-Reported Satisfaction

  12 months

• Cost Per Patient

  12 months

Study Arms (1)

Feasibility

EXPERIMENTAL

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

Interventions

Breathe Anew Survivorship Program COMBINATION_PRODUCT

The feasibility will be tested of the Breathe Anew Survivorship Program

Also known as: Wearable Technology, Mindfulness Therapy

Feasibility

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 12, 2018
• Study Start: January 2, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: March 4, 2022

Record last verified: 2022-03

Locations

CA (1)