Lung CancerPhase 1BANCT03773380
Breathe Anew for Lung Cancer Survivorship
A Phase 1 study testing Breathe Anew Survivorship Program in people with Lung Cancer, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Breathe Anew Survivorship Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jan 2019to 1 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breathe Anew: Designing and Testing the Feasibility of a Novel Intervention 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.
- Conditions
- Lung Cancer
- Being tested
- Breathe Anew Survivorship Program
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathe Anew Survivorship ProgramCombination product
Also called Wearable Technology, Mindfulness Therapy
The feasibility will be tested of the Breathe Anew Survivorship Program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Breathe Anew Survivorship Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance
The feasibility of Breath Anew, as measured by a rate of compliance of >70% with all the components of the intervention.
Measured: 12 months
Secondary outcomes (3)
Accrual Rate
Rate of accrual to the intervention
Measured: 12 months
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).
Measured: 12 months
Cost Per Patient
Cost per patient for the duration of the intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start2 Jan 2019
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wael Hanna, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773380
- Sponsor's protocol ID
- SJHH-BA
- Acronym
- BA
- Status last verified
- Mar 2022
- First submitted
- 10 Dec 2018
- Last updated
- 4 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathe Anew: Designing and Testing the Feasibility of a Novel Intervention for Lung Cancer Survivorship
- ClinicalTrials.gov ID
- NCT03773380
- Acronym / sponsor ID
- BA / SJHH-BA
- Conditions
- Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 12 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility | Experimental | Combination Product: Breathe Anew Survivorship Program50 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathe Anew Survivorship ProgramAlso: Wearable Technology, Mindfulness TherapyThe feasibility will be tested of the Breathe Anew Survivorship Program | Combination product | Feasibility |
Primary outcome
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.
3 secondary outcomes
Accrual Rate
Time frame: 12 months
Patient-Reported Satisfaction
Time frame: 12 months
Cost Per Patient
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Breathe Anew Survivorship Program in people with Lung Cancer, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.