Lung Cancer, Nonsmall CellEarly Phase 1Breathe EasierNCT06060964
Enabling Remote Access to Breathe Easier: A Novel Approach to Improve Symptom Management
A Early Phase 1 study testing Breathe Easier Progressive Web Application in people with Lung Cancer, Nonsmall Cell and Lung Cancer Stage I, run by University of South Carolina at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the preliminary affects of "Breathe Easier," an evidence-based multi-level mindfulness intervention (i.e., progressive web application) for survivors of lung cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer, Nonsmall Cell, Lung Cancer Stage I, Lung Cancer Stage II
- What is being tested?
- Breathe Easier Progressive Web Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2023to 15 Feb 2024
- Phase
- Early 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must be a White or African-American survivor of NSCLC, stages I-III, have access to a smart phone, have internet access, and be willing and able to use a mobile application and participate in daily meditations/gentle movement exercises for 8-weeks.
Who cannot join
- Persons not meeting all inclusion criteria will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
Otis Owens, PhD, 803-777-0384, owenso@mailbox.sc.edu
Karen McDonnell, PhD, 803-777-9866, karenkm@mailbox.sc.edu
About this study
Official title: Enabling Remote Access to Breathe Easier: A Novel Approach to Improve Symptom Self-Management and Wellness for Survivors of Lung Cancer and Their Family Members
The goal of this clinical trial is to evaluate the preliminary affects of "Breathe Easier," an evidence-based multi-level mindfulness intervention (i.e., progressive web application) for survivors of lung cancer. The key aims of this study are to (1) Evaluate the feasibility (usability, acceptability intervention adherence) of the "Breathe Easier" and (2) assess the impact of the intervention on dyspnea, fatigue, and quality of life among survivors of lung cancer. Participants in the intervention group will use the "Breathe Easier" progressive web application for a period of 8-weeks, while participants in the control group will receive no intervention. Researchers will compare the intervention and control groups to see if there are salient differences in dyspnea, fatigue, and quality of life between the two groups.
Read the detailed description
Cancer, a major health problem worldwide, is the second leading cause of death in the United States. As cancer death rates drop, the population of survivors of cancer is growing, projected to reach 18 million by 2022, with an estimated 800,000 of those being long-term survivors. Lung cancer is the second-most diagnosed cancer, accounting for more cancer deaths than breast, colorectal, and prostate cancers combined. Approximately 80% of patients with lung cancer will be diagnosed with non-small cell lung cancer (NSCLC), and about 25% will present with early-stage or localized disease (stages I-III). Lower prevalence of cigarette smoking, screening improvements, and treatment advances are improving five-year survival rates (currently 59% for stages I-II, 32% for stage III) [1-3]. Survivors of lung cancer will not only be more numerous but will be living longer. A diagnosis of lung cancer provides an opportunity to introduce targeted, effective, family-focused interventions. Developing interventions for self-managing lung cancer as a chronic illness is imperative. This project supports the strategic research priorities of the National Institute of Nursing Research (NINR) and National Cancer Institute (NCI) by developing and testing an evidence-based multi-level mindfulness intervention, Breathe Easier (BE), using the ORBIT model for behavioral intervention development and a theory-guided approach based on the individual and family self-management theory (IFSMT). BE empowers survivors and family members to manage symptoms and change unhealthy behaviors together.
SPECIFIC AIMS: The long-term goal of our research is to improve outcomes for survivors of NSCLC, stages I-III, and their family members. Our specific aims are as follows:
(1) Evaluate the feasibility (usability, acceptability intervention adherence) of BE and (2) Assess the preliminary effects (dyspnea, fatigue, quality of life) among survivors of lung cancer who receive the intervention as compared with those who do not receive BE.
- Conditions
- Lung Cancer, Nonsmall Cell, Lung Cancer Stage I, Lung Cancer Stage II, Lung Cancer Stage III
- Being tested
- Breathe Easier Progressive Web Application
- Keywords
- mindfulness, lung cancer, technology
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathe Easier Progressive Web ApplicationOther
The Breathe Easier Progressive Web Application is an 8-week, mindfulness based cancer recovery training program consisting of breathing retraining exercises, mindfulness meditation, gentle yoga, and cancer-specific educational activities, guided by a combination of written instructions, video, and audio. The progressive web application can be downloaded onto any mobile device.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in this group will use the Breathe Easier progressive web application each day for a period of 8-weeks. Receives: Other: Breathe Easier Progressive Web Application |
| Non-intervention Group (Control Group) | No intervention | Participants in this group will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue (FACIT Fatigue Scale v. 4)
13 items measuring individual fatigue during usual activity level over the past 7 days; 4-point Likert scale, ranging from 4 (Not at All Fatigued) to 0 (Very Much Fatigued). Scores range 0-52 (< 30 indicates severe fatigue)
Measured: Administered prior to the start of intervention and immediately following the intervention.
Dyspnea (MRC Breathlessness Scale)
1 item, comprised of five statements that describe almost the entire range of respiratory disability from none (Grade 1) to almost complete incapacity (Grade 5). It can be self-administered by asking subjects to choose a phrase that best describes their condition, e.g. 'I only get breathless with strenuous exertion' (Grade 1) or 'I am too breathless to leave the house' (Grade 5)
Measured: Administered prior to the start of intervention and immediately following the intervention.
Quality of Life (SF-36 Medical Outcomes Survey)
36 items that are meant to reflect 8 domains of health, including physical functioning, physical role, pain, general health, vitality, social function, emotional role, and mental health. Likert scales and yes/no options are used to assess function and well-being on this 36-item questionnaire.
Measured: Administered prior to the start of intervention and immediately following the intervention.
Secondary outcomes (3)
Usability (System Usability Scale)
10 items measuring usability; 5-point Likert scale, ranging from 1 (Strongly disagree) to 5 (Strongly disagree). Converted scores range from 0 to 100 (> 68 indicates average usability)
Measured: Administered only to intervention group immediately following the 8-week intervention
Acceptability (Acceptability of Intervention Measure)
4-items measuring perceived intervention acceptability; 5-point Likert scale ranging from 1 (Completely Disagree) to 5 (Completely Agree). Score is creating by calculated mean across items.
Measured: Administered only to intervention group immediately following the 8-week intervention
Intervention Adherence
number of intervention days/activities completed.
Measured: Administered only to intervention group immediately following the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start2 Oct 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion15 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Nonsmall CellStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Otis (Shaun) Owens, University of South Carolina
- Investigators
- Otis Owens, PhD, Principal investigator, Associate ProfessorKaren McDonnell, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060964
- Sponsor's protocol ID
- 00122553
- Acronym
- Breathe Easier
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, there is no plan to make individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enabling Remote Access to Breathe Easier: A Novel Approach to Improve Symptom Self-Management and Wellness for Survivors of Lung Cancer and Their Family Members
- ClinicalTrials.gov ID
- NCT06060964
- Acronym / sponsor ID
- Breathe Easier / 00122553
- Conditions
- Lung Cancer, Nonsmall Cell, Lung Cancer Stage I, Lung Cancer Stage II, Lung Cancer Stage III
- Keywords
- mindfulness, lung cancer, technology
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 2 Oct 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 29 Sep 2023 (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.
The goal of this clinical trial is to evaluate the preliminary affects of "Breathe Easier," an evidence-based multi-level mindfulness intervention (i.e., progressive web application) for survivors of lung cancer. The key aims of this study are to (1) Evaluate the feasibility (usability, acceptability intervention adherence) of the "Breathe Easier" and (2) assess the impact of the intervention on dyspnea, fatigue, and quality of life among survivors of lung cancer. Participants in the intervention group will use the "Breathe Easier" progressive web application for a period of 8-weeks, while participants in the control group will receive no intervention. Researchers will compare the intervention and control groups to see if there are salient differences in dyspnea, fatigue, and quality of life between the two groups.
Detailed description
Cancer, a major health problem worldwide, is the second leading cause of death in the United States. As cancer death rates drop, the population of survivors of cancer is growing, projected to reach 18 million by 2022, with an estimated 800,000 of those being long-term survivors. Lung cancer is the second-most diagnosed cancer, accounting for more cancer deaths than breast, colorectal, and prostate cancers combined. Approximately 80% of patients with lung cancer will be diagnosed with non-small cell lung cancer (NSCLC), and about 25% will present with early-stage or localized disease (stages I-III). Lower prevalence of cigarette smoking, screening improvements, and treatment advances are improving five-year survival rates (currently 59% for stages I-II, 32% for stage III) [1-3]. Survivors of lung cancer will not only be more numerous but will be living longer. A diagnosis of lung cancer provides an opportunity to introduce targeted, effective, family-focused interventions. Developing interventions for self-managing lung cancer as a chronic illness is imperative. This project supports the strategic research priorities of the National Institute of Nursing Research (NINR) and National Cancer Institute (NCI) by developing and testing an evidence-based multi-level mindfulness intervention, Breathe Easier (BE), using the ORBIT model for behavioral intervention development and a theory-guided approach based on the individual and family self-management theory (IFSMT). BE empowers survivors and family members to manage symptoms and change unhealthy behaviors together.
SPECIFIC AIMS: The long-term goal of our research is to improve outcomes for survivors of NSCLC, stages I-III, and their family members. Our specific aims are as follows:
(1) Evaluate the feasibility (usability, acceptability intervention adherence) of BE and (2) Assess the preliminary effects (dyspnea, fatigue, quality of life) among survivors of lung cancer who receive the intervention as compared with those who do not receive BE.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Breathe Easier Progressive Web ApplicationParticipants in this group will use the Breathe Easier progressive web application each day for a period of 8-weeks. |
| Non-intervention Group (Control Group) | No intervention | –Participants in this group will receive no intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Must be a White or African-American survivor of NSCLC, stages I-III, have access to a smart phone, have internet access, and be willing and able to use a mobile application and participate in daily meditations/gentle movement exercises for 8-weeks.
Key exclusion criteria (1 listed)
- Persons not meeting all inclusion criteria will be excluded.
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 Easier Progressive Web ApplicationThe Breathe Easier Progressive Web Application is an 8-week, mindfulness based cancer recovery training program consisting of breathing retraining exercises, mindfulness meditation, gentle yoga, and cancer-specific educational activities, guided by a combination of written instructions, video, and audio. The progressive web application can be downloaded onto any mobile device. | Other | Intervention Group |
Primary outcome
Fatigue (FACIT Fatigue Scale v. 4)
Time frame: Administered prior to the start of intervention and immediately following the intervention.
13 items measuring individual fatigue during usual activity level over the past 7 days; 4-point Likert scale, ranging from 4 (Not at All Fatigued) to 0 (Very Much Fatigued). Scores range 0-52 (< 30 indicates severe fatigue)
Dyspnea (MRC Breathlessness Scale)
Time frame: Administered prior to the start of intervention and immediately following the intervention.
1 item, comprised of five statements that describe almost the entire range of respiratory disability from none (Grade 1) to almost complete incapacity (Grade 5). It can be self-administered by asking subjects to choose a phrase that best describes their condition, e.g. 'I only get breathless with strenuous exertion' (Grade 1) or 'I am too breathless to leave the house' (Grade 5)
Quality of Life (SF-36 Medical Outcomes Survey)
Time frame: Administered prior to the start of intervention and immediately following the intervention.
36 items that are meant to reflect 8 domains of health, including physical functioning, physical role, pain, general health, vitality, social function, emotional role, and mental health. Likert scales and yes/no options are used to assess function and well-being on this 36-item questionnaire.
3 secondary outcomes
Usability (System Usability Scale)
Time frame: Administered only to intervention group immediately following the 8-week intervention
Acceptability (Acceptability of Intervention Measure)
Time frame: Administered only to intervention group immediately following the 8-week intervention
Intervention Adherence
Time frame: Administered only to intervention group immediately following the 8-week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No. At this time, there is no plan to make individual participant data available.
Related trials for Lung Cancer, Nonsmall Cell
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Non-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic
RecruitingObservational study
Real-World Outcomes of Sevabertinib in HER2-Mutant Advanced NSCLC: A Bidirectional Cohort Study
HER2-mutant Advanced Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 2
Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer
Early Stage Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
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.
Otis Owens, PhD principal investigator
Associate Professor
Karen McDonnell, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Breathe Easier Progressive Web Application in people with Lung Cancer, Nonsmall Cell and Lung Cancer Stage I, run by University of South Carolina at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Sep 2023. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Otis Owens, PhD (803-777-0384, owenso@mailbox.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (FACIT Fatigue Scale v. 4) (time frame: Administered prior to the start of intervention and immediately following the intervention.). The study lists 3 primary outcomes in all. 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 29 Sep 2023.