Lung CancerNCT03500393

A Remotely Supervised Exercise Program for Lung Cancer Patients Undergoing Chemoradiation (REM)

A study testing Remotely Supervised Exercise (REM) and Unsupervised Exercise (UNSUP) in people with Lung Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to conduct a pilot randomized controlled trial (RCT) evaluating the feasibility and potential effectiveness of a remotely supervised exercise program (REM) in promoting adherence to an exercise prescription before and during chemoradiation. 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?: Remotely Supervised Exercise (REM) and Unsupervised Exercise (UNSUP)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: 22 Jun 2018to 23 Jan 2021
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

Are over the age of 18 and diagnosed with Stage IIa to IIIb lung cancer;
Definitive treatment with chemoradiation with weekly carboplatin and paclitaxel concurrent with radiation is planned to begin in no less than 2 weeks;
Have an Apple or Android device with capacity to install a fitness device app and access to either WiFi or cellular service;
Are English-speaking and able to provide voluntary, written consent;
Able to tolerate chemoradiation as indicated by Zubrod/ECOG Performance Status 0-1; CBC/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl;Adequate renal function within 14 days prior to registration, defined as creatinine clearance must be at least 35 ml/min; Adequate hepatic function within 14 days prior to registration, defined as total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution and ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution; No prior thoracic radiation therapy;

Who cannot join

Life expectancy of < 12 months or are receiving hospice services;
Psychiatric diagnosis that would require significant study modification to meet their needs such as uncontrolled severe mental illness, substance abuse, or active suicidal ideation;
Exhibit American College of Sports Medicine contraindications to exercise which include a resting heart rate of >120bpm, blood pressure >180/100mmHg or unstable angina 40 or musculoskeletal issue preventing exercise;
Are unable to walk 100 meters. According to our current standard of care, those participants will be referred to physical therapy for evaluation and treatment and will be excluded from the study as unsupervised exercise would not be safe;
Less than 2 weeks to the beginning of chemoradiation;
Physician discretion;
Are unable to walk or to complete the 6-minute walk test. According to our current standard of care, those participants will be referred to physical therapy for evaluation and treatment and will be excluded from the study as unsupervised exercise would not be safe.

Trial locations and contacts

1 site in 1 country.

United States1 site

Dartmouth Hitchcock Medical Center
Hanover, New Hampshire, 03756

Other trials in United States

About this study

Official title: A Remotely Supervised Exercise Program for Lung Cancer Patients Undergoing Chemoradiation

Read the detailed description

The research team adopts an overtly pragmatic approach where our design choices are made to enhance external validity and create a parsimonious intervention that can be integrated into busy clinical practices. This is a pilot study and is not designed to definitively provide evidence for a treatment effect, but rather to establish feasibility and to optimize the intervention and study procedures in preparation for a larger trial. We will conduct a pilot RCT comparing a remotely supervised exercise program (REM) to an unsupervised exercise program (UNSUP). Data will be collected upon enrollment (T0; at least 2 weeks prior to beginning chemoradiation), immediately prior to chemoradiation (T1), immediately post-chemoradiation (T2) and 1-month post-chemoradiation (T3).

Conditions: Lung Cancer
Being tested: Remotely Supervised Exercise (REM), Unsupervised Exercise (UNSUP)
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Remotely Supervised Exercise (REM)Behavioural
REM is designed to follow in the tradition of stepped care behavioral interventions. As such, participants who are successfully engaging in the prescribed exercise are provided minimal and automated encouragement and praise. Participants who demonstrate less adherence are given interventions that are tailored in content and intensity, depending on the level of success and the nature of the barriers to success
Unsupervised Exercise (UNSUP)Behavioural
The control condition represents a minimalist intervention that could occur in any setting: (1) enthusiastic provision on an exercise prescription and (2) provision of a fitness device (i.e., the Garmin VivioActive) that can help participants track their exercise engagement. Participants are instructed in how to use the device to track their adherence to the exercise prescription.

Study groups in NCT03500393
Study group	Role	What they receive
Unsupervised Exercise (UNSUP)	Active comparator	The control condition represents a minimalist intervention that could occur in any setting: (1) enthusiastic provision on an exercise prescription and (2) provision of a fitness device (i.e., the Garmin VivioActive) that can help participants track their exercise engagement. Participants are instructed in how to use the device to track their adherence to the exercise prescription. Receives: Behavioral: Unsupervised Exercise (UNSUP)
Remotely Supervised Exercise (REM)	Experimental	The REM program is designed to function as an Acceptance-based health coaching intervention and will utilize theory-based behavior change techniques (i.e., goal setting/action planning, self-monitoring, receiving feedback, and reviewing relevant goals in the light of feedback) to promote adoption and adherence to the exercise prescription. Receives: Behavioral: Remotely Supervised Exercise (REM)

What is being measured

The primary outcome is the main question the study is designed to answer.

Recruitment and retention statistics
Number of participants enrolled/number of patients eligible; Number completing all data collection/Number enrolled; Number adhering to randomization/number enrolled; Number withdrawn/number enrolled
Measured: Time 3, One month after completing chemoradiation

Secondary outcomes (12)

Minutes spent in exercise
Objective measure of adherence to exercise prescription; collected from fitness device
Measured: Time 3, One month after completing chemoradiation
6-minute walk test
Observational measure of aerobic capacity (measures how far you can walk in six minutes)
Measured: Time 3, One month after completing chemoradiation
Timed up-and-go test
Observational measure of functional capacity/balance and agility (measures how long it takes to rise walk three meters, turn and sit)
Measured: Time 3, One month after completing chemoradiation
Five times sit-to-stand test
Observational measure of functional capacity/lower extremity strength (measures how long it take to rise from and sit down in chair five times)
Measured: Time 3, One month after completing chemoradiation
Forced expiratory volume in 1 second
Pulmonary function will be measured by forced expiratory volume in 1 second (FEV1). This will be measured by a pulmonary medicine technician as part of the pre-chemoradiation (T0) exam and 1-month post-treatment (T3).
Measured: Time 3, One month after completing chemoradiation
Diffusion capacity
Pulmonary function will be measured by the diffusing capacity of lungs for carbon monoxide (DLCO). This will be measured by a pulmonary medicine technician as part of the pre-chemoradiation (T0) exam and 1-month post-treatment (T3).
Measured: Time 3, One month after completing chemoradiation
Forced vital capacity
Pulmonary function will be measured by forced vital capacity (FVC). This will be measured by a pulmonary medicine technician as part of the pre-chemoradiation (T0) exam and 1-month post-treatment (T3).
Measured: Time 3, One month after completing chemoradiation
Physical Function Scale of the Patient Reported Outcomes Measurement information System (PROMIS)
The 10-item physical function scale of the PROMIS Item Bank36 will be administered to the participant by the research assistant. The items ask respondents to determine the degree to which health interferes with mobility and daily living tasks. The scale has an internal reliability coefficient of 0.81 and was found to correlate positively with quality of life and negatively with pain impact. Higher scores indicate better physical function.
Measured: Time 3, One month after completing chemoradiation
Pittsburgh Sleep Quality Index
From the actigraphy data from the Garmin fitness device, we can calculate sleep onset latency (SOL), total sleep time (TST), wake after sleep onset (WASO), and sleep efficiency (SE). It is expected that increased exercise in cancer patients will follow by decreased SOL and WASO, increased TST and SE, and improvements in subjective sleep quality. The Pittsburgh Sleep Quality Index (PSQI) is a widely used measure of sleep quality, in the time frame of 2 weeks prior to the assessment. PSQI assesses a range of sleep disturbances, including symptoms of insomnia, symptoms of sleep-related breathing disorders, use of sleep medications, etc. PSQI score over 5 is indicative of significant sleep disturbances. We would expect that PSQI score would decrease following increased exercise in cancer patients.
Measured: Time 3, One month after completing chemoradiation
Functional Assessment of Cancer Therapy-fatigue scale
The Functional Assessment of Cancer Treatment- Fatigue (FACT-F) instrument will be used to measure quality of life and, specifically, effects of cancer-related fatigue upon quality of life .37 The FACT-F is a 40-item self-report measure of health-related quality of life specifically designed for cancer patients. The first 27 items of the tool represent the general version of the FACT (FACT-G) which assesses perceived well-being in physical, social, emotional, and functional domains. The remainder of the tool addresses concerns directly relevant to fatigue. Higher scores indicate higher quality of life.
Measured: Time 3, One month after completing chemoradiation
Dose reductions
Medical record audits will be conducted to determine the degree to which participants received the prescribed regimen of chemoradiation (performed at T2).
Measured: Time 3, One month after completing chemoradiation
Grip strength
Grip strength has been found to effectively identify people with clinically significant weakness that correlates with disability.60 Using a JAMAR Handheld Dynamometer, the subject will hold the device in their dominant hand, with the arm at right angles and the elbow by the side of the body. No other body movement is allowed. The subject squeezes the dynamometer with maximum isometric effort and maintained for about 5 seconds. The subject should be strongly encouraged to give maximum effort. The best result from several trials for each hand is recorded with at least 15 seconds recovery between each effort.
Measured: Time 3, one month after completing chemoradiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jun 201823 Jan 2021

First posted18 Apr 2018
Study start22 Jun 2018
Primary completion23 Jan 2021
Study completion23 Jan 2021

Why it stopped: feasibility of study recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (68)Papers the sponsor has linked to this study.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by Dartmouth-Hitchcock Medical CenterThe 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomized to the remotely supervised exercise (REM) or the unsupervised exercise (UNSUP) arm upon completion of the baseline assessment battery.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03500393
Sponsor's protocol ID: D18012
Status last verified: Jan 2021
First submitted: 16 Mar 2018
Last updated: 2 Feb 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

American Cancer Society. Cancer Facts and Figures 2016. Atlanta, GA2016
Furuse K, Fukuoka M, Kawahara M, Nishikawa H, Takada Y, Kudoh S, Katagami N, Ariyoshi Y. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer. J Clin Oncol. 1999 Sep;17(9):2692-9. doi: 10.1200/JCO.1999.17.9.2692.
PubMed 10561343
Margaritora S, Cesario A, Cusumano G, Cafarotti S, Corbo GM, Ferri L, Ceppi M, Meacci E, Valente S, D'Angelillo RM, Russo P, Porziella V, Bonassi S, Pasqua F, Sterzi S, Granone P. Is pulmonary function damaged by neoadjuvant lung cancer therapy? A comprehensive serial time-trend analysis of pulmonary function after induction radiochemotherapy plus surgery. J Thorac Cardiovasc Surg. 2010 Jun;139(6):1457-63. doi: 10.1016/j.jtcvs.2009.10.023. Epub 2010 Apr 2.
PubMed 20363001
Pasqua F, Biscione G, Crigna G, Auciello L, Cazzola M. Combining triple therapy and pulmonary rehabilitation in patients with advanced COPD: a pilot study. Respir Med. 2010 Mar;104(3):412-7. doi: 10.1016/j.rmed.2009.10.005. Epub 2009 Nov 4.
PubMed 19892540
Cesario A, Ferri L, Galetta D, Pasqua F, Bonassi S, Clini E, Biscione G, Cardaci V, di Toro S, Zarzana A, Margaritora S, Piraino A, Russo P, Sterzi S, Granone P. Post-operative respiratory rehabilitation after lung resection for non-small cell lung cancer. Lung Cancer. 2007 Aug;57(2):175-80. doi: 10.1016/j.lungcan.2007.02.017. Epub 2007 Apr 17.
PubMed 17442449
Jackson W, Alexander N, Schipper M, Fig L, Feng F, Jolly S. Characterization of changes in total body composition for patients with head and neck cancer undergoing chemoradiotherapy using dual-energy x-ray absorptiometry. Head Neck. 2014 Sep;36(9):1356-62. doi: 10.1002/hed.23461. Epub 2013 Nov 21.
PubMed 23970480
Carli F, Scheede-Bergdahl C. Prehabilitation to enhance perioperative care. Anesthesiol Clin. 2015 Mar;33(1):17-33. doi: 10.1016/j.anclin.2014.11.002. Epub 2015 Jan 9.
PubMed 25701926
Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options, and improve physical and psychological health outcomes. Am J Phys Med Rehabil. 2013 Aug;92(8):715-27. doi: 10.1097/PHM.0b013e31829b4afe.
PubMed 23756434
Carli F, Zavorsky GS. Optimizing functional exercise capacity in the elderly surgical population. Curr Opin Clin Nutr Metab Care. 2005 Jan;8(1):23-32. doi: 10.1097/00075197-200501000-00005.
PubMed 15585997
Jones LW, Watson D, Herndon JE 2nd, Eves ND, Haithcock BE, Loewen G, Kohman L. Peak oxygen consumption and long-term all-cause mortality in nonsmall cell lung cancer. Cancer. 2010 Oct 15;116(20):4825-32. doi: 10.1002/cncr.25396.
PubMed 20597134
Tarumi S, Yokomise H, Gotoh M, Kasai Y, Matsuura N, Chang SS, Go T. Pulmonary rehabilitation during induction chemoradiotherapy for lung cancer improves pulmonary function. J Thorac Cardiovasc Surg. 2015 Feb;149(2):569-73. doi: 10.1016/j.jtcvs.2014.09.123. Epub 2014 Oct 5.
PubMed 25451483
Yeh SH, Lai HL, Hsiao CY, Lin LW, Chuang YK, Yang YY, Yang KD. Moderate physical activity of music aerobic exercise increases lymphocyte counts, specific subsets, and differentiation. J Phys Act Health. 2014 Sep;11(7):1386-92. doi: 10.1123/jpah.2012-0508. Epub 2013 Dec 20.
PubMed 24368695
Wang R, Liu J, Chen P, Yu D. Regular tai chi exercise decreases the percentage of type 2 cytokine-producing cells in postsurgical non-small cell lung cancer survivors. Cancer Nurs. 2013 Jul-Aug;36(4):E27-34. doi: 10.1097/NCC.0b013e318268f7d5.
PubMed 23051870
Silver JK. Cancer prehabilitation and its role in improving health outcomes and reducing health care costs. Semin Oncol Nurs. 2015 Feb;31(1):13-30. doi: 10.1016/j.soncn.2014.11.003. Epub 2014 Dec 3.
PubMed 25636392
Kleinman MS, Mold JW. Defining the components of the research pipeline. Clin Transl Sci. 2009 Aug;2(4):312-4. doi: 10.1111/j.1752-8062.2009.00119.x.
PubMed 20443910

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Remotely Supervised Exercise Program for Lung Cancer Patients Undergoing Chemoradiation
ClinicalTrials.gov ID: NCT03500393
Acronym / sponsor ID: D18012
Conditions: Lung Cancer
Study type: Interventional
Recruitment status: TerminatedReason stopped: feasibility of study recruitment
Enrolment: 4 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Study start: 22 Jun 2018 (actual)
Primary completion: 23 Jan 2021 (actual)
Study completion: 23 Jan 2021 (actual)
First posted: 18 Apr 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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Participants will be randomized to the remotely supervised exercise (REM) or the unsupervised exercise (UNSUP) arm upon completion of the baseline assessment battery.

Arm	Type	Receives
Unsupervised Exercise (UNSUP)	Active comparator	Behavioral: Unsupervised Exercise (UNSUP)The control condition represents a minimalist intervention that could occur in any setting: (1) enthusiastic provision on an exercise prescription and (2) provision of a fitness device (i.e., the Garmin VivioActive) that can help participants track their exercise engagement. Participants are instructed in how to use the device to track their adherence to the exercise prescription.
Remotely Supervised Exercise (REM)	Experimental	Behavioral: Remotely Supervised Exercise (REM)The REM program is designed to function as an Acceptance-based health coaching intervention and will utilize theory-based behavior change techniques (i.e., goal setting/action planning, self-monitoring, receiving feedback, and reviewing relevant goals in the light of feedback) to promote adoption and adherence to the exercise prescription.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Are over the age of 18 and diagnosed with Stage IIa to IIIb lung cancer;
Definitive treatment with chemoradiation with weekly carboplatin and paclitaxel concurrent with radiation is planned to begin in no less than 2 weeks;
Have an Apple or Android device with capacity to install a fitness device app and access to either WiFi or cellular service;
Are English-speaking and able to provide voluntary, written consent;
Able to tolerate chemoradiation as indicated by Zubrod/ECOG Performance Status 0-1; CBC/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl;Adequate renal function within 14 days prior to registration, defined as creatinine clearance must be at least 35 ml/min; Adequate hepatic function within 14 days prior to registration, defined as total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution and ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution; No prior thoracic radiation therapy;

Key exclusion criteria (7 listed)

Life expectancy of < 12 months or are receiving hospice services;
Psychiatric diagnosis that would require significant study modification to meet their needs such as uncontrolled severe mental illness, substance abuse, or active suicidal ideation;
Exhibit American College of Sports Medicine contraindications to exercise which include a resting heart rate of >120bpm, blood pressure >180/100mmHg or unstable angina 40 or musculoskeletal issue preventing exercise;
Are unable to walk 100 meters. According to our current standard of care, those participants will be referred to physical therapy for evaluation and treatment and will be excluded from the study as unsupervised exercise would not be safe;
Less than 2 weeks to the beginning of chemoradiation;

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
Remotely Supervised Exercise (REM)REM is designed to follow in the tradition of stepped care behavioral interventions. As such, participants who are successfully engaging in the prescribed exercise are provided minimal and automated encouragement and praise. Participants who demonstrate less adherence are given interventions that are tailored in content and intensity, depending on the level of success and the nature of the barriers to success	Behavioural	Remotely Supervised Exercise (REM)
Unsupervised Exercise (UNSUP)The control condition represents a minimalist intervention that could occur in any setting: (1) enthusiastic provision on an exercise prescription and (2) provision of a fitness device (i.e., the Garmin VivioActive) that can help participants track their exercise engagement. Participants are instructed in how to use the device to track their adherence to the exercise prescription.	Behavioural	Unsupervised Exercise (UNSUP)

Primary outcome

Recruitment and retention statistics
Time frame: Time 3, One month after completing chemoradiation
Number of participants enrolled/number of patients eligible; Number completing all data collection/Number enrolled; Number adhering to randomization/number enrolled; Number withdrawn/number enrolled

12 secondary outcomes

Minutes spent in exercise
Time frame: Time 3, One month after completing chemoradiation
6-minute walk test
Time frame: Time 3, One month after completing chemoradiation
Timed up-and-go test
Time frame: Time 3, One month after completing chemoradiation
Five times sit-to-stand test
Time frame: Time 3, One month after completing chemoradiation
Forced expiratory volume in 1 second
Time frame: Time 3, One month after completing chemoradiation
Diffusion capacity
Time frame: Time 3, One month after completing chemoradiation
Forced vital capacity
Time frame: Time 3, One month after completing chemoradiation
Physical Function Scale of the Patient Reported Outcomes Measurement information System (PROMIS)
Time frame: Time 3, One month after completing chemoradiation
Pittsburgh Sleep Quality Index
Time frame: Time 3, One month after completing chemoradiation
Functional Assessment of Cancer Therapy-fatigue scale
Time frame: Time 3, One month after completing chemoradiation
Dose reductions
Time frame: Time 3, One month after completing chemoradiation
Grip strength
Time frame: Time 3, one month after completing chemoradiation

Results and safety

The study was stopped early (reason given: feasibility of study recruitment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
BackgroundAmerican Cancer Society. Cancer Facts and Figures 2016. Atlanta, GA2016
Background: PubMed 10561343Furuse K, Fukuoka M, Kawahara M, Nishikawa H, Takada Y, Kudoh S, Katagami N, Ariyoshi Y. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer. J Clin Oncol. 1999 Sep;17(9):2692-9. doi: 10.1200/JCO.1999.17.9.2692.
Background: PubMed 20363001Margaritora S, Cesario A, Cusumano G, Cafarotti S, Corbo GM, Ferri L, Ceppi M, Meacci E, Valente S, D'Angelillo RM, Russo P, Porziella V, Bonassi S, Pasqua F, Sterzi S, Granone P. Is pulmonary function damaged by neoadjuvant lung cancer therapy? A comprehensive serial time-trend analysis of pulmonary function after induction radiochemotherapy plus surgery. J Thorac Cardiovasc Surg. 2010 Jun;139(6):1457-63. doi: 10.1016/j.jtcvs.2009.10.023. Epub 2010 Apr 2.
Background: PubMed 19892540Pasqua F, Biscione G, Crigna G, Auciello L, Cazzola M. Combining triple therapy and pulmonary rehabilitation in patients with advanced COPD: a pilot study. Respir Med. 2010 Mar;104(3):412-7. doi: 10.1016/j.rmed.2009.10.005. Epub 2009 Nov 4.
Background: PubMed 17442449Cesario A, Ferri L, Galetta D, Pasqua F, Bonassi S, Clini E, Biscione G, Cardaci V, di Toro S, Zarzana A, Margaritora S, Piraino A, Russo P, Sterzi S, Granone P. Post-operative respiratory rehabilitation after lung resection for non-small cell lung cancer. Lung Cancer. 2007 Aug;57(2):175-80. doi: 10.1016/j.lungcan.2007.02.017. Epub 2007 Apr 17.
Background: PubMed 23970480Jackson W, Alexander N, Schipper M, Fig L, Feng F, Jolly S. Characterization of changes in total body composition for patients with head and neck cancer undergoing chemoradiotherapy using dual-energy x-ray absorptiometry. Head Neck. 2014 Sep;36(9):1356-62. doi: 10.1002/hed.23461. Epub 2013 Nov 21.
Background: PubMed 25701926Carli F, Scheede-Bergdahl C. Prehabilitation to enhance perioperative care. Anesthesiol Clin. 2015 Mar;33(1):17-33. doi: 10.1016/j.anclin.2014.11.002. Epub 2015 Jan 9.
Background: PubMed 23756434Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options, and improve physical and psychological health outcomes. Am J Phys Med Rehabil. 2013 Aug;92(8):715-27. doi: 10.1097/PHM.0b013e31829b4afe.
Background: PubMed 15585997Carli F, Zavorsky GS. Optimizing functional exercise capacity in the elderly surgical population. Curr Opin Clin Nutr Metab Care. 2005 Jan;8(1):23-32. doi: 10.1097/00075197-200501000-00005.
Background: PubMed 20597134Jones LW, Watson D, Herndon JE 2nd, Eves ND, Haithcock BE, Loewen G, Kohman L. Peak oxygen consumption and long-term all-cause mortality in nonsmall cell lung cancer. Cancer. 2010 Oct 15;116(20):4825-32. doi: 10.1002/cncr.25396.
Background: PubMed 25451483Tarumi S, Yokomise H, Gotoh M, Kasai Y, Matsuura N, Chang SS, Go T. Pulmonary rehabilitation during induction chemoradiotherapy for lung cancer improves pulmonary function. J Thorac Cardiovasc Surg. 2015 Feb;149(2):569-73. doi: 10.1016/j.jtcvs.2014.09.123. Epub 2014 Oct 5.
Background: PubMed 24368695Yeh SH, Lai HL, Hsiao CY, Lin LW, Chuang YK, Yang YY, Yang KD. Moderate physical activity of music aerobic exercise increases lymphocyte counts, specific subsets, and differentiation. J Phys Act Health. 2014 Sep;11(7):1386-92. doi: 10.1123/jpah.2012-0508. Epub 2013 Dec 20.
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.

Kathleen Lyons, ScD principal investigator

Dartmouth-Hitchcock Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Remotely Supervised Exercise (REM) and Unsupervised Exercise (UNSUP) in people with Lung Cancer, run by Dartmouth-Hitchcock Medical Center 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 5 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: stopped early, as of the sponsor's last update on 2 Feb 2021. 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 was stopped early (reason given: feasibility of study recruitment). Results are not available in the source record.

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?

Recruitment and retention statistics (time frame: Time 3, One month after completing chemoradiation). 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 NCT03500393, which also lists 68 linked publications.

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 2 Feb 2021.