ExerciseNCT03883243
Monitoring and Telecoaching of Physical Activity in Patients With Stage III and IV Non-small Cell Lung Cancer
A study testing Telecoaching in people with Exercise and Neoplasms, run by KU Leuven at 1 site in Belgium.
Trial summary
This study is a prospective non-randomised control study to evaluate the efficacy of a physical activity promotion program on the experience of physical activity in patients with stage III and IV non-small cell lung cancer (NSCLC) with documented disease control (stable disease, partial or complete response defined by… Read more about this study
- Who is it for?
- Ages 19 years and older
- What is being tested?
- Telecoaching
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Mar 2019to 31 Dec 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients actively participating in a pulmonary rehabilitation program
- Patients with sequential chemoradiotherapy for stadium III non-small cell lung cancer
- The presence of orthopedic problems not allowing an increase in PA levels
Trial locations and contacts
1 site in 1 country.
About this study
This study is a prospective non-randomised control study to evaluate the efficacy of a physical activity promotion program on the experience of physical activity in patients with stage III and IV non-small cell lung cancer (NSCLC) with documented disease control (stable disease, partial or complete response defined by RECIST V1.1) at least 6 months after start of first line treatment.
The trial will consist of 4 visits. An outpatient clinic visit in which the eligible patients are invited (V1), a screenings visit (V2), a third visit (V3) at which the patients will be divided into the intervention or the control group, according to owning a smartphone and their affinity with it, followed by the start of the intervention consisting of 8 weeks telecoaching by means of an application and step counter and a final visit (V4) 8 weeks after starting up the intervention.
Read the detailed description
The objective of this pilot study is to investigate if physical activity can be improved by telecoaching in patients with advanced stages of lung cancer in remission. We hypothesize that a smartphone application, designed for a population with respiratory symptoms, will increase daily physical activity, which translates into significant improvements on quality of life. This uncontrolled pilot study will therefore address if a 8-week PA promotion telecoaching program in addition to usual care has the potential to improve physical activity and quality of life in patients with lung cancer for a limited burden and at low cost.
This trial consists of 4 visits:
Visit 1 (V1, outpatient clinic):
Patients will be screened for inclusion in the study during follow up visits in the outpatient lung cancer clinic. If oncological check-up 6 months after starting initial lung cancer treatment demonstrates objective response (partial response or complete response defined by RECIST V1.1) the patient is asked to join the study. If the patient wants to join the study a screening visit (V2) will be planned.
Visit 2 (V2, screening visit (run-in)):
During V2 all eligible patients who have signed the informed consent will enter the run in epoch of 1 to 2 weeks.
Patients are asked about their medical history (baseline demographic data) and their previous respiratory treatment including their oncological stage and type. Co-morbidities will also be assessed and a basic lung function will be performed.
On V2 patient will receive a Dynaport movemonitor to wear one week before V3. For patients where the run in period is more than one week, they will receive a telephone reminder to wear a PROactive monitor. Patients are instructed to wear the device during waking hours. A measurement of more than 8 hours of wearing time will be defined as a 'valid day). The tri-axial accelerometer will captured steps waked per day, movement intensity and time spent in sitting, lying walking and high-intense activities.
Visit 3 (V3, baseline, allocation):
Patients will complete the web-based version of the clinical visit of the PROactive questionnaire. Two six-minutes walk tests will be performed and the patient will complete 2 quality of life questionnaires (SGRQ and QLQ-C30). During V3, the patients are divided into either control (usual care) or telecoaching group based on personal preferences and the abilities of using and having a smartphone.
Patients in both groups will receive a brochure during this visit explaining the importance of physical activity with recommendations to improve it. This brochure will be discussed together with the patients.
In the intervention group patients will recieve the telecoaching intervention consisting of the following components: 1: motivational interview with the investigator discussing motivation, barriers, favourite activities and strategies to become more active; 2: a pedometer giving direct feedback on the amount of steps; 3: the coaching application linked to the pedometer, which will be installed on the patient's smartphone and which will be coaching the patient for 8 weeks by means of improving the amount of steps per day. 4: telephone contact when a patient is non-compliant with either the use of the coaching intervention or with achieving the physical activity goals for 2 consecutive weeks.
All patients will be equipped with the Dynaport movemonitor one week before V4 and will be instructed to wear the monitor for 7 consecutive days.
Visit 4 (V4, end of the study, 8 weeks post allocation):
V4 is the end of the study. All assessments performed on V3 will be repeated during this study visit.
- Being tested
- Telecoaching
- Keywords
- Telecoaching, Physical activity, Lung cancer
- Medical subject headings
- Motor Activity, Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelecoachingDevice
A telecoaching application linked to a step counter will be installed on a patients smartphone for 8 weeks. The application shows a daily goal (expressed as amount of steps per day) to the patient. This goal is weekly revised and patients themselves are able to increase the goal every week with 500 or 1000 steps/day. Every evening, they are able to check the daily feedback platform, which gives them insights in their physical activity pattern of the day and previous weeks. At a regular basis, 'tip of the day' messages appear as a pop-up, to keep patients motivated.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients will only receive a brochure explaining the importance of physical activity with recommendations to improve it. |
| Telecoaching | Experimental | Patients will receive a brochure explaining the importance of physical activity with recommendations to improve it. Next to this patients will receive the telecoaching intervention in which a coaching application linked to a step counter is installed on the patients smartphone, which will weekly give a new physical activity goal to improve the amount of steps per day for 8 weeks. Receives: Device: Telecoaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average daily number of steps
To assess the impact of a telecoaching program on physical activity in patients with stage III and IV NSCLC in addition to usual care. This will be measured by the Dynaport movemonitor (Dynaport®), as the change in average daily number of steps at baseline (1 week preceding V3) and at the end (1 week preceding V4) in the intervention and the control group.
Measured: 8 weeks
Secondary outcomes (2)
Change in health status
Change in health status assessed by QLQ-C30 (Cancer quality of life questionnaire) at baseline (1 week preceding) and at the end (1 week preceding) in the intervention and the control group.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level
Measured: 8 weeks
Change in exercise capacity
Change in exercise capacity by 6 minutes walking distance at baseline and at the end in the intervention and the control group.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start15 Mar 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective non-randomised controlled pilot study. 16 patients will be included in the intervention group and 16 patients will be included in a matched control group receiving only usual care.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wim Janssens, KU Leuven
- Investigators
- Wim Janssens, Prof. Dr., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883243
- Sponsor's protocol ID
- S62244
- Status last verified
- Apr 2019
- First submitted
- 4 Feb 2019
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, because this is a pilot trail we are not going to share the data with other researchers.
Publications
Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA Cancer J Clin. 2014 Jan-Feb;64(1):9-29. doi: 10.3322/caac.21208. Epub 2014 Jan 7.
PubMed 24399786Zappa C, Mousa SA. Non-small cell lung cancer: current treatment and future advances. Transl Lung Cancer Res. 2016 Jun;5(3):288-300. doi: 10.21037/tlcr.2016.06.07.
PubMed 27413711Dela Cruz CS, Tanoue LT, Matthay RA. Lung cancer: epidemiology, etiology, and prevention. Clin Chest Med. 2011 Dec;32(4):605-44. doi: 10.1016/j.ccm.2011.09.001.
PubMed 22054876Johnsen AT, Petersen MA, Pedersen L, Groenvold M. Symptoms and problems in a nationally representative sample of advanced cancer patients. Palliat Med. 2009 Sep;23(6):491-501. doi: 10.1177/0269216309105400. Epub 2009 May 14.
PubMed 19443525Thompson E, Sola I, Subirana M. Non-invasive interventions for improving well-being and quality of life in patients with lung cancer--a systematic review of the evidence. Lung Cancer. 2005 Nov;50(2):163-76. doi: 10.1016/j.lungcan.2005.06.004. Epub 2005 Aug 31.
PubMed 16137786Lee IM, Shiroma EJ, Lobelo F, Puska P, Blair SN, Katzmarzyk PT; Lancet Physical Activity Series Working Group. Effect of physical inactivity on major non-communicable diseases worldwide: an analysis of burden of disease and life expectancy. Lancet. 2012 Jul 21;380(9838):219-29. doi: 10.1016/S0140-6736(12)61031-9.
PubMed 22818936Kraus WE, Bittner V, Appel L, Blair SN, Church T, Despres JP, Franklin BA, Miller TD, Pate RR, Taylor-Piliae RE, Vafiadis DK, Whitsel L; American Heart Association Physical Activity Committee of the Council on Lifestyle and Metabolic Health, Council on Clinical Cardiology, Council on Hypertension, and Council on Cardiovascular and Stroke Nursing. The National Physical Activity Plan: a call to action from the American Heart Association: a science advisory from the American Heart Association. Circulation. 2015 May 26;131(21):1932-40. doi: 10.1161/CIR.0000000000000203. Epub 2015 Apr 27. No abstract available.
PubMed 25918126Fong DY, Ho JW, Hui BP, Lee AM, Macfarlane DJ, Leung SS, Cerin E, Chan WY, Leung IP, Lam SH, Taylor AJ, Cheng KK. Physical activity for cancer survivors: meta-analysis of randomised controlled trials. BMJ. 2012 Jan 30;344:e70. doi: 10.1136/bmj.e70.
PubMed 22294757Lee IM. Physical activity and cancer prevention--data from epidemiologic studies. Med Sci Sports Exerc. 2003 Nov;35(11):1823-7. doi: 10.1249/01.MSS.0000093620.27893.23.
PubMed 14600545Granger CL, Connolly B, Denehy L, Hart N, Antippa P, Lin KY, Parry SM. Understanding factors influencing physical activity and exercise in lung cancer: a systematic review. Support Care Cancer. 2017 Mar;25(3):983-999. doi: 10.1007/s00520-016-3484-8. Epub 2016 Nov 29.
PubMed 27900549Michaels C. The importance of exercise in lung cancer treatment. Transl Lung Cancer Res. 2016 Jun;5(3):235-8. doi: 10.21037/tlcr.2016.03.02.
PubMed 27413700Kuehr L, Wiskemann J, Abel U, Ulrich CM, Hummler S, Thomas M. Exercise in patients with non-small cell lung cancer. Med Sci Sports Exerc. 2014 Apr;46(4):656-63. doi: 10.1249/MSS.0000000000000158.
PubMed 24042307Cramp F, Byron-Daniel J. Exercise for the management of cancer-related fatigue in adults. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD006145. doi: 10.1002/14651858.CD006145.pub3.
PubMed 23152233Bade BC, Thomas DD, Scott JB, Silvestri GA. Increasing physical activity and exercise in lung cancer: reviewing safety, benefits, and application. J Thorac Oncol. 2015 Jun;10(6):861-71. doi: 10.1097/JTO.0000000000000536.
PubMed 25831230Conn VS, Hafdahl AR, Brown SA, Brown LM. Meta-analysis of patient education interventions to increase physical activity among chronically ill adults. Patient Educ Couns. 2008 Feb;70(2):157-72. doi: 10.1016/j.pec.2007.10.004. Epub 2007 Nov 26.
PubMed 18023128
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring and Telecoaching of Physical Activity in Patients With Stage III and IV Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03883243
- Acronym / sponsor ID
- S62244
- Keywords
- Telecoaching, Physical activity, Lung cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 20 Mar 2019 (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 study is a prospective non-randomised control study to evaluate the efficacy of a physical activity promotion program on the experience of physical activity in patients with stage III and IV non-small cell lung cancer (NSCLC) with documented disease control (stable disease, partial or complete response defined by RECIST V1.1) at least 6 months after start of first line treatment.
The trial will consist of 4 visits. An outpatient clinic visit in which the eligible patients are invited (V1), a screenings visit (V2), a third visit (V3) at which the patients will be divided into the intervention or the control group, according to owning a smartphone and their affinity with it, followed by the start of the intervention consisting of 8 weeks telecoaching by means of an application and step counter and a final visit (V4) 8 weeks after starting up the intervention.
Detailed description
The objective of this pilot study is to investigate if physical activity can be improved by telecoaching in patients with advanced stages of lung cancer in remission. We hypothesize that a smartphone application, designed for a population with respiratory symptoms, will increase daily physical activity, which translates into significant improvements on quality of life. This uncontrolled pilot study will therefore address if a 8-week PA promotion telecoaching program in addition to usual care has the potential to improve physical activity and quality of life in patients with lung cancer for a limited burden and at low cost.
This trial consists of 4 visits:
Visit 1 (V1, outpatient clinic):
Patients will be screened for inclusion in the study during follow up visits in the outpatient lung cancer clinic. If oncological check-up 6 months after starting initial lung cancer treatment demonstrates objective response (partial response or complete response defined by RECIST V1.1) the patient is asked to join the study. If the patient wants to join the study a screening visit (V2) will be planned.
Visit 2 (V2, screening visit (run-in)):
During V2 all eligible patients who have signed the informed consent will enter the run in epoch of 1 to 2 weeks.
Patients are asked about their medical history (baseline demographic data) and their previous respiratory treatment including their oncological stage and type. Co-morbidities will also be assessed and a basic lung function will be performed.
On V2 patient will receive a Dynaport movemonitor to wear one week before V3. For patients where the run in period is more than one week, they will receive a telephone reminder to wear a PROactive monitor. Patients are instructed to wear the device during waking hours. A measurement of more than 8 hours of wearing time will be defined as a 'valid day). The tri-axial accelerometer will captured steps waked per day, movement intensity and time spent in sitting, lying walking and high-intense activities.
Visit 3 (V3, baseline, allocation):
Patients will complete the web-based version of the clinical visit of the PROactive questionnaire. Two six-minutes walk tests will be performed and the patient will complete 2 quality of life questionnaires (SGRQ and QLQ-C30). During V3, the patients are divided into either control (usual care) or telecoaching group based on personal preferences and the abilities of using and having a smartphone.
Patients in both groups will receive a brochure during this visit explaining the importance of physical activity with recommendations to improve it. This brochure will be discussed together with the patients.
In the intervention group patients will recieve the telecoaching intervention consisting of the following components: 1: motivational interview with the investigator discussing motivation, barriers, favourite activities and strategies to become more active; 2: a pedometer giving direct feedback on the amount of steps; 3: the coaching application linked to the pedometer, which will be installed on the patient's smartphone and which will be coaching the patient for 8 weeks by means of improving the amount of steps per day. 4: telephone contact when a patient is non-compliant with either the use of the coaching intervention or with achieving the physical activity goals for 2 consecutive weeks.
All patients will be equipped with the Dynaport movemonitor one week before V4 and will be instructed to wear the monitor for 7 consecutive days.
Visit 4 (V4, end of the study, 8 weeks post allocation):
V4 is the end of the study. All assessments performed on V3 will be repeated during this study visit.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective non-randomised controlled pilot study. 16 patients will be included in the intervention group and 16 patients will be included in a matched control group receiving only usual care.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients will only receive a brochure explaining the importance of physical activity with recommendations to improve it. |
| Telecoaching | Experimental | Device: TelecoachingPatients will receive a brochure explaining the importance of physical activity with recommendations to improve it. Next to this patients will receive the telecoaching intervention in which a coaching application linked to a step counter is installed on the patients smartphone, which will weekly give a new physical activity goal to improve the amount of steps per day for 8 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Patients actively participating in a pulmonary rehabilitation program
- Patients with sequential chemoradiotherapy for stadium III non-small cell lung cancer
- The presence of orthopedic problems not allowing an increase in PA levels
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 |
|---|---|---|
| TelecoachingA telecoaching application linked to a step counter will be installed on a patients smartphone for 8 weeks. The application shows a daily goal (expressed as amount of steps per day) to the patient. This goal is weekly revised and patients themselves are able to increase the goal every week with 500 or 1000 steps/day. Every evening, they are able to check the daily feedback platform, which gives them insights in their physical activity pattern of the day and previous weeks. At a regular basis, 'tip of the day' messages appear as a pop-up, to keep patients motivated. | Device | Telecoaching |
Primary outcome
Change in average daily number of steps
Time frame: 8 weeks
To assess the impact of a telecoaching program on physical activity in patients with stage III and IV NSCLC in addition to usual care. This will be measured by the Dynaport movemonitor (Dynaport®), as the change in average daily number of steps at baseline (1 week preceding V3) and at the end (1 week preceding V4) in the intervention and the control group.
2 secondary outcomes
Change in health status
Time frame: 8 weeks
Change in exercise capacity
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Background: PubMed 24399786Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA Cancer J Clin. 2014 Jan-Feb;64(1):9-29. doi: 10.3322/caac.21208. Epub 2014 Jan 7.
- Background: PubMed 27413711Zappa C, Mousa SA. Non-small cell lung cancer: current treatment and future advances. Transl Lung Cancer Res. 2016 Jun;5(3):288-300. doi: 10.21037/tlcr.2016.06.07.
- Background: PubMed 22054876Dela Cruz CS, Tanoue LT, Matthay RA. Lung cancer: epidemiology, etiology, and prevention. Clin Chest Med. 2011 Dec;32(4):605-44. doi: 10.1016/j.ccm.2011.09.001.
- Background: PubMed 19443525Johnsen AT, Petersen MA, Pedersen L, Groenvold M. Symptoms and problems in a nationally representative sample of advanced cancer patients. Palliat Med. 2009 Sep;23(6):491-501. doi: 10.1177/0269216309105400. Epub 2009 May 14.
- Background: PubMed 16137786Thompson E, Sola I, Subirana M. Non-invasive interventions for improving well-being and quality of life in patients with lung cancer--a systematic review of the evidence. Lung Cancer. 2005 Nov;50(2):163-76. doi: 10.1016/j.lungcan.2005.06.004. Epub 2005 Aug 31.
- Background: PubMed 22818936Lee IM, Shiroma EJ, Lobelo F, Puska P, Blair SN, Katzmarzyk PT; Lancet Physical Activity Series Working Group. Effect of physical inactivity on major non-communicable diseases worldwide: an analysis of burden of disease and life expectancy. Lancet. 2012 Jul 21;380(9838):219-29. doi: 10.1016/S0140-6736(12)61031-9.
- Background: PubMed 25918126Kraus WE, Bittner V, Appel L, Blair SN, Church T, Despres JP, Franklin BA, Miller TD, Pate RR, Taylor-Piliae RE, Vafiadis DK, Whitsel L; American Heart Association Physical Activity Committee of the Council on Lifestyle and Metabolic Health, Council on Clinical Cardiology, Council on Hypertension, and Council on Cardiovascular and Stroke Nursing. The National Physical Activity Plan: a call to action from the American Heart Association: a science advisory from the American Heart Association. Circulation. 2015 May 26;131(21):1932-40. doi: 10.1161/CIR.0000000000000203. Epub 2015 Apr 27. No abstract available.
- Background: PubMed 22294757Fong DY, Ho JW, Hui BP, Lee AM, Macfarlane DJ, Leung SS, Cerin E, Chan WY, Leung IP, Lam SH, Taylor AJ, Cheng KK. Physical activity for cancer survivors: meta-analysis of randomised controlled trials. BMJ. 2012 Jan 30;344:e70. doi: 10.1136/bmj.e70.
- Background: PubMed 14600545Lee IM. Physical activity and cancer prevention--data from epidemiologic studies. Med Sci Sports Exerc. 2003 Nov;35(11):1823-7. doi: 10.1249/01.MSS.0000093620.27893.23.
- Background: PubMed 27900549Granger CL, Connolly B, Denehy L, Hart N, Antippa P, Lin KY, Parry SM. Understanding factors influencing physical activity and exercise in lung cancer: a systematic review. Support Care Cancer. 2017 Mar;25(3):983-999. doi: 10.1007/s00520-016-3484-8. Epub 2016 Nov 29.
- Background: PubMed 27413700Michaels C. The importance of exercise in lung cancer treatment. Transl Lung Cancer Res. 2016 Jun;5(3):235-8. doi: 10.21037/tlcr.2016.03.02.
- Background: PubMed 24042307Kuehr L, Wiskemann J, Abel U, Ulrich CM, Hummler S, Thomas M. Exercise in patients with non-small cell lung cancer. Med Sci Sports Exerc. 2014 Apr;46(4):656-63. doi: 10.1249/MSS.0000000000000158.
- Treatment stage IV NSCLC (Dutch)Link provided by the sponsor.
- Individual participant dataSharing planned: No. No, because this is a pilot trail we are not going to share the data with other researchers.
Related trials for Exercise
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
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.
Wim Janssens, Prof. Dr. principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telecoaching in people with Exercise and Neoplasms, run by KU Leuven at 1 site in Belgium.
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 0 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: status not confirmed, as of the sponsor's last update on 24 Apr 2019. 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 Belgium. 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?
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?
Change in average daily number of steps (time frame: 8 weeks). 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 NCT03883243, which also lists 26 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 24 Apr 2019.