Lung Cancer, Small CellWATTOXNCT04440800
Feasibility of Wearable Activity Trackers for Detection of TOXicity in People Receiving Systemic Anticancer Treatment
An observational study of Lung Cancer, Small Cell and Pancreatic Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Accurate evaluation of activity status is an important part of the assessment of people with cancer. Clinician assessments currently used are valuable but have limitations; in particular, assessment only occurs when the patient attends clinic and is often subjective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Small Cell, Pancreatic Cancer, Gastric Cancer
- What is being tested?
- Wearable activity tracker - FitBit
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2020to Sep 2021
- Phase
- Observational
- 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
Study population: The participant population whose data will be subjected to the study analysis includes registered patients for whom baseline median daily step count was available and who were compliant with wearing the device during the follow up.
Who may be able to join
- Age >/= 18.
- Advanced lung (NSCLC or SCLC) cancer or patients with upper gastrointestinal cancer (gastric, oesophageal, pancreatic) starting a new line of systemic anti-cancer therapy.
- Willingness to wear an activity tracker and undergo remote monitoring
- Access to a smart phone.
- Willingness to have a Fitbit App installed on their smartphone
- Willingness to have a pseudo- anonymised FitBit account created for the purposes of the study
- PS 0-2.
- 1 or more previous lines of treatment.
Who cannot join
- Physical conditions that preclude daily walking
- Inability to give informed consent.
- Medical or psychiatric condition which in the investigators opinion would affect the successful completion of the study.
- Immediate need to start systemic anticancer therapy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Marsden NHS Foundation Trust - London and Surrey
London, SM2 5PT
Agnieszka Yousaf, +44 0208 642 6011 ext. 3018, Agnieszka.Yongue@rmh.nhs.uk
Bianca Peet, +44 0208 642 6011, bianca.peet@rmh.nhs.uk
About this study
Official title: Remote Monitoring of Wearable Activity Trackers for Detection of TOXicity in People Receiving Systemic Anticancer Treatment: a Feasibility Study
Accurate evaluation of activity status is an important part of the assessment of people with cancer. Clinician assessments currently used are valuable but have limitations; in particular, assessment only occurs when the patient attends clinic and is often subjective. Activity trackers, such as FitBits, give the opportunity to objectively assess activity status continuously, independent of clinic visits. Previous studies have shown that a reduction in 1000 steps while receiving cancer treatment is associated with an increased risk of hospitalisation but it is not known if using information from activity trackers to allow early intervention is feasible or if it can reduce admission to hospital and improve outcomes.
The investigators propose a prospective feasibility study in people with advanced lung cancer or upper gastrointestinal cancers who are starting a new line of systemic anti-cancer therapy.
Participants will receive a FitBit, which is a commercially available wearable activity tracker for the duration of their treatment or 4 months (whichever is shorter). Step counts will be monitored and a reduction in daily steps of >1000 from baseline will trigger contact by the study team and an ambulatory review. Participants will not receive treatment within the context of the study.
Read the detailed description
A recent metanalysis reports that over 40% of people with cancer being treated with palliative intent have at least 1 unplanned hospital admission during treatment. Furthermore, up to 83% of people undergoing cancer treatment are likely to attend the Emergency Departments (ED). The 2019 NHS long-term plan has an emphasis on the use of digital technologies, remote monitoring to support patients, and acute ambulatory care as an alternative to ED attendance.
In observational studies of people with cancer, reductions in steps counts correlate with increased symptoms and risk of hospitalisation.
Therefore, the main aim of this study is to determine whether monitoring of activity and subsequent ambulatory review triggered by detecting a reduction in steps is feasible in a timely fashion within an NHS oncology centre.
People with advanced lung cancer (NSCLC, SCLC) or upper gastrointestinal cancers (gastric, oesophageal or pancreatic) starting a new line of systemic anti-cancer treatment (SACT) will be recruited at The Royal Marsden Hospital (Chelsea and Sutton sites). Eligible patients will be approached by clinical teams in the lung and gastrointestinal cancer outpatient clinics.
Participants who are due to start a new line of SACT will be asked to wear a FitBit activity tracker (resembling a watch). Baseline median daily steps count will be calculated prior starting SACT for those patients who wear the device for ideally 7 consecutive days, which must include both weekend and week days.
The device can measure step counts and heart rate. The FitBit will be monitored remotely by the study team once a day (week days only) using a web-based platform called Fitabase and will document cases where the step count reduction is >1000 from baseline. Step count and average heart rate data will be downloaded at the beginning of each treatment cycle and a summary reported in the MACRO database. Fitabase is a cloud-based data management platform, which is able to access data which has been synchronised from individual FitBits. Data can be collected anonymously by associating the device data with a study identification number. Fitabase does not collect personally identifiable data. No global positioning system (GPS) data or other data is collected. Passwords are encrypted.
For this feasibility study, activity tracking will take place on working week days only.
A reduction in >1000 steps from the baseline median step count will trigger a telephone call by a member of the study team. If the fall in steps was not due to non-compliance/malfunction of the device, the participant will be invited to attend the Clinical Assessment Unit for an ambulatory review. Participants' acceptance of advice to attend for a review will be documented. The diagnosis (and clinical necessity as assessed by a clinician), need for hospitalisation or not, and length of stay will be collected. Further investigations or management will be determined by clinical need following assessment by a member of the study team.
If no abnormality is noted the trigger for subsequent phone calls will be adjusted by 500 steps for that patient ie >1500 steps. If no abnormality is found after a second review, further reviews will only take place after a phone call if there is clinical concern.
Participants will be informed at the beginning of the study to use usual processes if they feel unwell at any time eg calling the Royal Marsden Macmillan Hotline (RMMH).
Participants will be reviewed at the start of each new cycle of treatment (+/- 7 days) by a member of the study team to find out if they have been hospitalised and for how long.
Physician-assessed PS, C reactive protein (CRP), albumin, handgrip strength (HGS), Timed Up and Go (TUaG) will be measured at the first study visit, and skeletal muscle area (SMA), skeletal muscle index (SMI) and muscle radiation attenuation (MRA) will be measured from the standard of care baseline CT scan. In addition the investigators will also collect height and weight demographics, and perform questionnaire-based nutritional (PG-SGA) and quality of life (QoL) (FACT-G, EORTC-q30C) assessments.
To assess changes in muscle quality and function, HGS, PS, and TUaG will be measured +/- 14 days from each standard of care CT scan. The participant will also undertake QoL and nutrition questionnaires as per baseline investigation. Weight will be recorded. The CT scan will be used to calculate SMA, SMI and MRA.
At the end of the study, 5-8 participants will be invited for a focus group to understand their acceptance and experience of remote activity monitoring while undertaking cancer treatment.
- Conditions
- Lung Cancer, Small Cell, Pancreatic Cancer, Gastric Cancer, Oesophageal Cancer, Lung Cancer, Nonsmall Cell, Lung Cancer Metastatic
- Being tested
- Wearable activity tracker - FitBit
- Medical subject headings
- Small Cell Lung Carcinoma, Pancreatic Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable activity tracker - FitBitDevice
Participants will be given a wearable activity tracker and their daily step count recorded. If there is a reduction from baseline of over 1000 steps, the participant will be contacted and an ambulatory review organised if the reduction is not due to a device compliance issue
| Study group | Role | What they receive |
|---|---|---|
| Study participants | All patients will receive the intervention Receives: Device: Wearable activity tracker - FitBit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of monitoring reductions in step count in people with advanced lung cancer or upper gastrointestinal cancers starting systemic anti-cancer therapy.
Feasibility of step count monitoring will be determined by measuring the proportion of participants for whom step count was successfully monitored (step count checked for at least 4 out 5 weekdays) for at least 80% of the treatment weeks during the study period.
Successful monitoring is defined as a member of the study team logging in to the Fitabase system to review the step count. If 80% of participants are monitored for 80% of the observational time (from the start until the end of treatment - either at completion or if treatment is stopped), this will be considered feasible.
Measured: Analysis 4 months after last patient recruited
Feasibility of undertaking a timely ambulatory review, of participants in whom a reduction of steps is detected
Feasibility of a timely ambulatory review will be determined by measuring the proportion of participants who are invited for an ambulatory review and attend within 24 hours. If 70% of participants invited for a review attend, this will be considered feasible.
Measured: Analysis 4 months after last patient recruited
Secondary outcomes (6)
Participant compliance with use of activity monitor
Percentage compliance with wearable activity trackers (WAT) will be defined as wearing the device for at least 70% of waking hours. It is assumed for the purposes of this study that participants are awake between 0700hrs to 2200hrs. Compliance can be assumed if the device is able to measure heart rate during these hours, which can be assessed from the daily heart rate graph.
Measured: Analysis 4 months after last patient recruited
Utility of monitoring steps counts as a trigger for ambulatory assessment for the identification of new or worsening adverse events in people with cancer.
The utility of monitoring steps counts for the identification of new or worsening adverse events in people with cancer will be assessed by recording the number of clinical reviews triggered by step count.
Measured: Analysis 4 months after last patient recruited
Sensitivity of monitoring steps counts for the identification of new or worsening adverse events in people with cancer
The sensitivity of monitoring steps counts for the identification of new or worsening adverse events in people with cancer will be assessed by recording how many of the triggered ambulatory assessments were deemed clinically appropriated by the assessing clinician.
Measured: Analysis 4 months after last patient recruited
Number of hospitalisation episodes.
The total number of hospitalisation episodes will be recorded, including all WAT-triggered ambulatory reviews and those that occur outside of the study visits
Measured: Analysis 4 months after last patient recruited
Proportion of hospitalisation episodes associated with WAT-triggered ambulatory reviews.
The proportion of hospitalisation episodes that were WAT-triggered clinical reviews, including those with no detected abnormality, will be compared to the number of episodes that were not associated with a WAT-triggered review.
Measured: Analysis 4 months after last patient recruited
Acceptability of remote activity tracking
Acceptability of remote activity tracking will be determined by assessing the qualitative patient experience of undergoing remote monitoring as determined by focus group interview
Measured: At study completion, approximately 1 year after beginning recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study startJul 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer, Small CellStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Yousaf, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440800
- Sponsor's protocol ID
- CCR5083
- Acronym
- WATTOX
- Status last verified
- Jun 2020
- First submitted
- 19 Feb 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ohri N, Kabarriti R, Bodner WR, Mehta KJ, Shankar V, Halmos B, Haigentz M Jr, Rapkin B, Guha C, Kalnicki S, Garg M. Continuous Activity Monitoring During Concurrent Chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2017 Apr 1;97(5):1061-1065. doi: 10.1016/j.ijrobp.2016.12.030. Epub 2016 Dec 25.
PubMed 28332990Gresham G, Hendifar AE, Spiegel B, Neeman E, Tuli R, Rimel BJ, Figlin RA, Meinert CL, Piantadosi S, Shinde AM. Wearable activity monitors to assess performance status and predict clinical outcomes in advanced cancer patients. NPJ Digit Med. 2018 Jul 5;1:27. doi: 10.1038/s41746-018-0032-6. eCollection 2018.
PubMed 31304309Prince RM, Powis M, Zer A, Atenafu EG, Krzyzanowska MK. Hospitalisations and emergency department visits in cancer patients receiving systemic therapy: Systematic review and meta-analysis. Eur J Cancer Care (Engl). 2019 Jan;28(1):e12909. doi: 10.1111/ecc.12909. Epub 2018 Sep 20.
PubMed 30238542Bennett AV, Reeve BB, Basch EM, Mitchell SA, Meeneghan M, Battaglini CL, Smith-Ryan AE, Phillips B, Shea TC, Wood WA. Evaluation of pedometry as a patient-centered outcome in patients undergoing hematopoietic cell transplant (HCT): a comparison of pedometry and patient reports of symptoms, health, and quality of life. Qual Life Res. 2016 Mar;25(3):535-46. doi: 10.1007/s11136-015-1179-0. Epub 2015 Nov 17.
PubMed 26577763Spruit MA, Sillen MJ, Groenen MT, Wouters EF, Franssen FM. New normative values for handgrip strength: results from the UK Biobank. J Am Med Dir Assoc. 2013 Oct;14(10):775.e5-11. doi: 10.1016/j.jamda.2013.06.013. Epub 2013 Aug 16.
PubMed 23958225
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring of Wearable Activity Trackers for Detection of TOXicity in People Receiving Systemic Anticancer Treatment: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04440800
- Acronym / sponsor ID
- WATTOX / CCR5083
- Conditions
- Lung Cancer, Small Cell, Pancreatic Cancer, Gastric Cancer, Oesophageal Cancer, Lung Cancer, Nonsmall Cell, Lung Cancer Metastatic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 22 Jun 2020 (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.
Accurate evaluation of activity status is an important part of the assessment of people with cancer. Clinician assessments currently used are valuable but have limitations; in particular, assessment only occurs when the patient attends clinic and is often subjective. Activity trackers, such as FitBits, give the opportunity to objectively assess activity status continuously, independent of clinic visits. Previous studies have shown that a reduction in 1000 steps while receiving cancer treatment is associated with an increased risk of hospitalisation but it is not known if using information from activity trackers to allow early intervention is feasible or if it can reduce admission to hospital and improve outcomes.
The investigators propose a prospective feasibility study in people with advanced lung cancer or upper gastrointestinal cancers who are starting a new line of systemic anti-cancer therapy.
Participants will receive a FitBit, which is a commercially available wearable activity tracker for the duration of their treatment or 4 months (whichever is shorter). Step counts will be monitored and a reduction in daily steps of >1000 from baseline will trigger contact by the study team and an ambulatory review. Participants will not receive treatment within the context of the study.
Detailed description
A recent metanalysis reports that over 40% of people with cancer being treated with palliative intent have at least 1 unplanned hospital admission during treatment. Furthermore, up to 83% of people undergoing cancer treatment are likely to attend the Emergency Departments (ED). The 2019 NHS long-term plan has an emphasis on the use of digital technologies, remote monitoring to support patients, and acute ambulatory care as an alternative to ED attendance.
In observational studies of people with cancer, reductions in steps counts correlate with increased symptoms and risk of hospitalisation.
Therefore, the main aim of this study is to determine whether monitoring of activity and subsequent ambulatory review triggered by detecting a reduction in steps is feasible in a timely fashion within an NHS oncology centre.
People with advanced lung cancer (NSCLC, SCLC) or upper gastrointestinal cancers (gastric, oesophageal or pancreatic) starting a new line of systemic anti-cancer treatment (SACT) will be recruited at The Royal Marsden Hospital (Chelsea and Sutton sites). Eligible patients will be approached by clinical teams in the lung and gastrointestinal cancer outpatient clinics.
Participants who are due to start a new line of SACT will be asked to wear a FitBit activity tracker (resembling a watch). Baseline median daily steps count will be calculated prior starting SACT for those patients who wear the device for ideally 7 consecutive days, which must include both weekend and week days.
The device can measure step counts and heart rate. The FitBit will be monitored remotely by the study team once a day (week days only) using a web-based platform called Fitabase and will document cases where the step count reduction is >1000 from baseline. Step count and average heart rate data will be downloaded at the beginning of each treatment cycle and a summary reported in the MACRO database. Fitabase is a cloud-based data management platform, which is able to access data which has been synchronised from individual FitBits. Data can be collected anonymously by associating the device data with a study identification number. Fitabase does not collect personally identifiable data. No global positioning system (GPS) data or other data is collected. Passwords are encrypted.
For this feasibility study, activity tracking will take place on working week days only.
A reduction in >1000 steps from the baseline median step count will trigger a telephone call by a member of the study team. If the fall in steps was not due to non-compliance/malfunction of the device, the participant will be invited to attend the Clinical Assessment Unit for an ambulatory review. Participants' acceptance of advice to attend for a review will be documented. The diagnosis (and clinical necessity as assessed by a clinician), need for hospitalisation or not, and length of stay will be collected. Further investigations or management will be determined by clinical need following assessment by a member of the study team.
If no abnormality is noted the trigger for subsequent phone calls will be adjusted by 500 steps for that patient ie >1500 steps. If no abnormality is found after a second review, further reviews will only take place after a phone call if there is clinical concern.
Participants will be informed at the beginning of the study to use usual processes if they feel unwell at any time eg calling the Royal Marsden Macmillan Hotline (RMMH).
Participants will be reviewed at the start of each new cycle of treatment (+/- 7 days) by a member of the study team to find out if they have been hospitalised and for how long.
Physician-assessed PS, C reactive protein (CRP), albumin, handgrip strength (HGS), Timed Up and Go (TUaG) will be measured at the first study visit, and skeletal muscle area (SMA), skeletal muscle index (SMI) and muscle radiation attenuation (MRA) will be measured from the standard of care baseline CT scan. In addition the investigators will also collect height and weight demographics, and perform questionnaire-based nutritional (PG-SGA) and quality of life (QoL) (FACT-G, EORTC-q30C) assessments.
To assess changes in muscle quality and function, HGS, PS, and TUaG will be measured +/- 14 days from each standard of care CT scan. The participant will also undertake QoL and nutrition questionnaires as per baseline investigation. Weight will be recorded. The CT scan will be used to calculate SMA, SMI and MRA.
At the end of the study, 5-8 participants will be invited for a focus group to understand their acceptance and experience of remote activity monitoring while undertaking cancer treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study participants | – | Device: Wearable activity tracker - FitBitAll patients will receive the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participant population whose data will be subjected to the study analysis includes registered patients for whom baseline median daily step count was available and who were compliant with wearing the device during the follow up.
Key inclusion criteria (8 listed)
- Age >/= 18.
- Advanced lung (NSCLC or SCLC) cancer or patients with upper gastrointestinal cancer (gastric, oesophageal, pancreatic) starting a new line of systemic anti-cancer therapy.
- Willingness to wear an activity tracker and undergo remote monitoring
- Access to a smart phone.
- Willingness to have a Fitbit App installed on their smartphone
Key exclusion criteria (4 listed)
- Physical conditions that preclude daily walking
- Inability to give informed consent.
- Medical or psychiatric condition which in the investigators opinion would affect the successful completion of the study.
- Immediate need to start systemic anticancer therapy
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 |
|---|---|---|
| Wearable activity tracker - FitBitParticipants will be given a wearable activity tracker and their daily step count recorded. If there is a reduction from baseline of over 1000 steps, the participant will be contacted and an ambulatory review organised if the reduction is not due to a device compliance issue | Device | Study participants |
Primary outcome
Feasibility of monitoring reductions in step count in people with advanced lung cancer or upper gastrointestinal cancers starting systemic anti-cancer therapy.
Time frame: Analysis 4 months after last patient recruited
Feasibility of step count monitoring will be determined by measuring the proportion of participants for whom step count was successfully monitored (step count checked for at least 4 out 5 weekdays) for at least 80% of the treatment weeks during the study period. Successful monitoring is defined as a member of the study team logging in to the Fitabase system to review the step count. If 80% of participants are monitored for 80% of the observational time (from the start until the end of treatment - either at completion or if treatment is stopped), this will be considered feasible.
Feasibility of undertaking a timely ambulatory review, of participants in whom a reduction of steps is detected
Time frame: Analysis 4 months after last patient recruited
Feasibility of a timely ambulatory review will be determined by measuring the proportion of participants who are invited for an ambulatory review and attend within 24 hours. If 70% of participants invited for a review attend, this will be considered feasible.
6 secondary outcomes
Participant compliance with use of activity monitor
Time frame: Analysis 4 months after last patient recruited
Utility of monitoring steps counts as a trigger for ambulatory assessment for the identification of new or worsening adverse events in people with cancer.
Time frame: Analysis 4 months after last patient recruited
Sensitivity of monitoring steps counts for the identification of new or worsening adverse events in people with cancer
Time frame: Analysis 4 months after last patient recruited
Number of hospitalisation episodes.
Time frame: Analysis 4 months after last patient recruited
Proportion of hospitalisation episodes associated with WAT-triggered ambulatory reviews.
Time frame: Analysis 4 months after last patient recruited
Acceptability of remote activity tracking
Time frame: At study completion, approximately 1 year after beginning recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Background: PubMed 28332990Ohri N, Kabarriti R, Bodner WR, Mehta KJ, Shankar V, Halmos B, Haigentz M Jr, Rapkin B, Guha C, Kalnicki S, Garg M. Continuous Activity Monitoring During Concurrent Chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2017 Apr 1;97(5):1061-1065. doi: 10.1016/j.ijrobp.2016.12.030. Epub 2016 Dec 25.
- Background: PubMed 31304309Gresham G, Hendifar AE, Spiegel B, Neeman E, Tuli R, Rimel BJ, Figlin RA, Meinert CL, Piantadosi S, Shinde AM. Wearable activity monitors to assess performance status and predict clinical outcomes in advanced cancer patients. NPJ Digit Med. 2018 Jul 5;1:27. doi: 10.1038/s41746-018-0032-6. eCollection 2018.
- Background: PubMed 30238542Prince RM, Powis M, Zer A, Atenafu EG, Krzyzanowska MK. Hospitalisations and emergency department visits in cancer patients receiving systemic therapy: Systematic review and meta-analysis. Eur J Cancer Care (Engl). 2019 Jan;28(1):e12909. doi: 10.1111/ecc.12909. Epub 2018 Sep 20.
- Background: PubMed 26577763Bennett AV, Reeve BB, Basch EM, Mitchell SA, Meeneghan M, Battaglini CL, Smith-Ryan AE, Phillips B, Shea TC, Wood WA. Evaluation of pedometry as a patient-centered outcome in patients undergoing hematopoietic cell transplant (HCT): a comparison of pedometry and patient reports of symptoms, health, and quality of life. Qual Life Res. 2016 Mar;25(3):535-46. doi: 10.1007/s11136-015-1179-0. Epub 2015 Nov 17.
- Background: PubMed 23958225Spruit MA, Sillen MJ, Groenen MT, Wouters EF, Franssen FM. New normative values for handgrip strength: results from the UK Biobank. J Am Med Dir Assoc. 2013 Oct;14(10):775.e5-11. doi: 10.1016/j.jamda.2013.06.013. Epub 2013 Aug 16.
- NHS England. NHS Long Term Plan January 2019Link provided by the sponsor.
- 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.
Nadia Yousaf principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, Small Cell and Pancreatic Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 8 inclusion and 4 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 22 Jun 2020. 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 Kingdom. 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?
Contact Bianca Peet (+44 0208 642 6011, Bianca.Peet@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of monitoring reductions in step count in people with advanced lung cancer or upper gastrointestinal cancers starting systemic anti-cancer therapy. (time frame: Analysis 4 months after last patient recruited). The study lists 2 primary outcomes in all. 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 NCT04440800, which also lists 5 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 22 Jun 2020.