Lung NeoplasmNCT05059132
Inspiratory Muscle Training and Behavioral Support to Alleviate Dyspnea and Promote Walking in Lung Cancer Survivors: A Pilot Study
A study testing Tele-rehabilitation and Education only in people with Lung Neoplasm, run by Kaiser Permanente at 1 site in United States.
Trial summary
This is a pilot randomized study to investigate the feasibility, acceptability, safety, and effects of a novel tele-rehabilitation intervention for stage I-IIIA lung cancer survivors following curative intent therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasm
- What is being tested?
- Tele-rehabilitation and Education only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2022to 31 Dec 2022
- Phase
- Interventional
- 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
- history of stage I-IIIA lung cancer;
- completed curative intent therapy (i.e., lung cancer resection surgery, definitive radiation, or concurrent chemoradiation) within 1-6 months;
- access to a mobile phone or personal computer with internet access;
- willingness to wear activity trackers
Who cannot join
- dementia (or cognitive impairment identified by chart review) resulting in inability to follow directions or provide written informed consent;
- acute myocardial infarction, ventricular tachycardia, ventricular fibrillation, acute cerebrovascular event, or acute asthma exacerbation in past 2 months;
- spontaneous pneumothorax in past 12 months;
- Parkinson's disease;
- multiple sclerosis;
- amyotrophic lateral sclerosis;
- additional movement/gait disorders that may be identified by chart review
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tele-rehabilitation Following Curative Intent Therapy of Lung Cancer
This is a pilot randomized study to investigate the feasibility, acceptability, safety, and effects of a novel tele-rehabilitation intervention for stage I-IIIA lung cancer survivors following curative intent therapy.
The specific aims and hypotheses are:
Read more
Specific Aim 1: Conduct a pilot, phase IIb, parallel randomized (1:1) study to investigate the feasibility, acceptability, and safety of inspiratory muscle training and behavioral support to promote walking in tele-rehabilitation with stage I-IIIA lung cancer survivors following curative intent therapy (N=40).
Hypothesis 1a: ≥ 20% eligible patients will enroll; ≥75% of participants will achieve ≥75% adherence to the tele-rehabilitation program.
Hypothesis 1b: ≥75% of participants will perceive tele-rehabilitation as acceptable (Telemedicine Satisfaction and Usefulness Questionnaire ≥4). There will be 0 intervention adverse events.
Specific Aim 2: Explore the effects of the tele-rehabilitation program (N=40).
Hypothesis 2: At 12 weeks, participants in the tele-rehabilitation (experimental) arm, compared to education only (control) arm, will have a trend of greater improvements in outcomes, including:
- accelerometry-measured physical activity (primary outcome); and
- functional capacity, self-reported physical activity, control of dyspnea and anxiety symptoms, sleep quality, and quality of life (secondary outcomes).
- Conditions
- Lung Neoplasm
- Being tested
- Tele-rehabilitation, Education only
- Keywords
- Pilot study, Tele-rehabilitation, Remote rehabilitation, Exercise therapy, Aerobic exercise, Physical activity
- Medical subject headings
- Lung Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-rehabilitationBehavioural
The tele-rehabilitation intervention will include education, inspiratory muscle training, and behavioral support to promote walking.
Education onlyOther
The education only arm will receive information on the importance of general exercise following lung cancer treatment.
| Study group | Role | What they receive |
|---|---|---|
| Tele-rehabilitation | Experimental | Participants in the tele-rehabilitation arm will receive a home-based, remotely delivered rehabilitation program. Receives: Behavioral: Tele-rehabilitation |
| Education only | Active comparator | Participants in the education arm will receive educational materials only, delivered through telecommunication messages. Receives: Other: Education only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in change in accelerometry-measured physical activity between baseline and week 12
Physical activity will be measured by the activPAL4 device (PAL Technologies, Ltd).
Measured: Baseline, mid study (week 6), and end of study (week 12).
Secondary outcomes (6)
Difference in change in functional capacity between baseline and week 12
Functional capacity will be measured using the mobile six-minute walk test.
Measured: Baseline, mid study (week 6), and end of study (week 12)
Difference in change in self-reported physical activity between baseline and week 12
Self-reported physical activity will be measured using the International Physical Activity Questionnaire - Short Form
Measured: Baseline, mid study (week 6), and end of study (week 12)
Difference in change in control of dyspnea between baseline and week 12
Dyspnea control will be measured using the the University of California, San Diego Shortness of Breath Questionnaire.
Measured: Baseline, mid study (week 6), and end of study (week 12)
Difference in change in anxiety symptoms between baseline and week 12
Anxiety symptoms will be measured using the General Anxiety Disorder-7
Measured: Baseline, mid study (week 6), and end of study (week 12)
Difference in change in sleep quality between baseline and week 12
Sleep quality will be measured using the Pittsburgh Sleep Quality Index
Measured: Baseline, mid study (week 6), and end of study (week 12)
Difference in change in quality of life between baseline and week 12
Quality of life will be measured using the St. George's Respiratory Questionnaire
Measured: Baseline, mid study (week 6), and end of study (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start10 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pilot, parallel randomized study of an exercise + behavioral support intervention to reduce dyspnea and improve walking behavior among lung cancer survivors following curative intent therapy. Forty participants will be randomized 1:1 to the intervention or control arm, with assessments of feasibility, acceptability, safety, and patient-centered outcomes. The intervention period is 12 weeks.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- American Lung Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059132
- Sponsor's protocol ID
- LCD-820773
- Status last verified
- Dec 2023
- First submitted
- 13 Sep 2021
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ha DM, Comer A, Dollar B, Bedoy R, Ford M, Gozansky WS, Zeng C, Arch JJ, Leach HJ, Malhotra A, Prochazka AV, Keith RL, Boxer RS. Telemedicine-based inspiratory muscle training and walking promotion with lung cancer survivors following curative intent therapy: a parallel-group pilot randomized trial. Support Care Cancer. 2023 Sep 1;31(9):546. doi: 10.1007/s00520-023-07999-7.
PubMed 37656252
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-rehabilitation Following Curative Intent Therapy of Lung Cancer
- ClinicalTrials.gov ID
- NCT05059132
- Acronym / sponsor ID
- LCD-820773
- Conditions
- Lung Neoplasm
- Keywords
- Pilot study, Tele-rehabilitation, Remote rehabilitation, Exercise therapy, Aerobic exercise, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- American Lung Association
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 Sep 2021 (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.
This is a pilot randomized study to investigate the feasibility, acceptability, safety, and effects of a novel tele-rehabilitation intervention for stage I-IIIA lung cancer survivors following curative intent therapy.
The specific aims and hypotheses are:
Specific Aim 1: Conduct a pilot, phase IIb, parallel randomized (1:1) study to investigate the feasibility, acceptability, and safety of inspiratory muscle training and behavioral support to promote walking in tele-rehabilitation with stage I-IIIA lung cancer survivors following curative intent therapy (N=40).
Hypothesis 1a: ≥ 20% eligible patients will enroll; ≥75% of participants will achieve ≥75% adherence to the tele-rehabilitation program.
Hypothesis 1b: ≥75% of participants will perceive tele-rehabilitation as acceptable (Telemedicine Satisfaction and Usefulness Questionnaire ≥4). There will be 0 intervention adverse events.
Specific Aim 2: Explore the effects of the tele-rehabilitation program (N=40).
Hypothesis 2: At 12 weeks, participants in the tele-rehabilitation (experimental) arm, compared to education only (control) arm, will have a trend of greater improvements in outcomes, including:
- accelerometry-measured physical activity (primary outcome); and
- functional capacity, self-reported physical activity, control of dyspnea and anxiety symptoms, sleep quality, and quality of life (secondary outcomes).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pilot, parallel randomized study of an exercise + behavioral support intervention to reduce dyspnea and improve walking behavior among lung cancer survivors following curative intent therapy. Forty participants will be randomized 1:1 to the intervention or control arm, with assessments of feasibility, acceptability, safety, and patient-centered outcomes. The intervention period is 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Tele-rehabilitation | Experimental | Behavioral: Tele-rehabilitationParticipants in the tele-rehabilitation arm will receive a home-based, remotely delivered rehabilitation program. |
| Education only | Active comparator | Other: Education onlyParticipants in the education arm will receive educational materials only, delivered through telecommunication messages. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- history of stage I-IIIA lung cancer;
- completed curative intent therapy (i.e., lung cancer resection surgery, definitive radiation, or concurrent chemoradiation) within 1-6 months;
- access to a mobile phone or personal computer with internet access;
- willingness to wear activity trackers
Key exclusion criteria (7 listed)
- dementia (or cognitive impairment identified by chart review) resulting in inability to follow directions or provide written informed consent;
- acute myocardial infarction, ventricular tachycardia, ventricular fibrillation, acute cerebrovascular event, or acute asthma exacerbation in past 2 months;
- spontaneous pneumothorax in past 12 months;
- Parkinson's disease;
- multiple sclerosis;
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 |
|---|---|---|
| Tele-rehabilitationThe tele-rehabilitation intervention will include education, inspiratory muscle training, and behavioral support to promote walking. | Behavioural | Tele-rehabilitation |
| Education onlyThe education only arm will receive information on the importance of general exercise following lung cancer treatment. | Other | Education only |
Primary outcome
Difference in change in accelerometry-measured physical activity between baseline and week 12
Time frame: Baseline, mid study (week 6), and end of study (week 12).
Physical activity will be measured by the activPAL4 device (PAL Technologies, Ltd).
6 secondary outcomes
Difference in change in functional capacity between baseline and week 12
Time frame: Baseline, mid study (week 6), and end of study (week 12)
Difference in change in self-reported physical activity between baseline and week 12
Time frame: Baseline, mid study (week 6), and end of study (week 12)
Difference in change in control of dyspnea between baseline and week 12
Time frame: Baseline, mid study (week 6), and end of study (week 12)
Difference in change in anxiety symptoms between baseline and week 12
Time frame: Baseline, mid study (week 6), and end of study (week 12)
Difference in change in sleep quality between baseline and week 12
Time frame: Baseline, mid study (week 6), and end of study (week 12)
Difference in change in quality of life between baseline and week 12
Time frame: Baseline, mid study (week 6), and end of study (week 12)
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 13 Dec 2023.
- Results publication: PubMed 37656252Ha DM, Comer A, Dollar B, Bedoy R, Ford M, Gozansky WS, Zeng C, Arch JJ, Leach HJ, Malhotra A, Prochazka AV, Keith RL, Boxer RS. Telemedicine-based inspiratory muscle training and walking promotion with lung cancer survivors following curative intent therapy: a parallel-group pilot randomized trial. Support Care Cancer. 2023 Sep 1;31(9):546. doi: 10.1007/s00520-023-07999-7.
- Individual participant dataSharing planned: No
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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 study testing Tele-rehabilitation and Education only in people with Lung Neoplasm, run by Kaiser Permanente 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 4 inclusion and 7 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 13 Dec 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.
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?
Difference in change in accelerometry-measured physical activity between baseline and week 12 (time frame: Baseline, mid study (week 6), and end of study (week 12).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05059132, which also lists 1 linked publication.
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 13 Dec 2023.