CancerSTAPPSNCT05927636
Systemic Treatment Related Toxicity Identified With a Smartphone APPlication Measuring Step Count
An observational study of Cancer and Systemic Treatment, run by Radboud University Medical Center at 3 sites in Netherlands.
Trial summary
The goal of this observational study is to investigate whether daily physical activities measured with a smartphone are related to the possible side effects or other physical complaints that arise as a result of cancer treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Systemic Treatment, Physical Activity
- How many people
- 411 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Sep 2022to 31 Mar 2024
- 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: All patients with cancer referred for systemic treatment of the outpatient clinic at the departments of Medical Oncology at participating centres.
Who may be able to join
- Age ≥18 years;
- Diagnosis of cancer with an indication of starting systemic treatment
- Knowledge how to handle smartphone with iOS version 11 or higher or Android version 7.0 or higher.
- Mastery of Dutch language
- Able and willing to give written informed consent
Who cannot join
- Cognitive disorders or severe emotional instability
- Wheelchair-depended at home, or immobile due to for example fracture
- Already participating in an exercise trial
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites, 3 recruiting
- Recruiting
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, 8934 AD
Joeri Douma, MD, +31582866660, joeri.douma@mcl.nl
Calvin Brouwer, Msc, +31243098205, calvin.brouwer@radboudumc.nl
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525GA
Laurien Buffart, PhD, +31243613674, laurien.buffart@radboudumc.nl
Calvin Brouwer, Msc, +31243098205, calvin.brouwer@radboudumc.nl
- Not yet recruiting
Erasmus MC
Rotterdam, South Holland, 3015 GD
Leni van Doorn, +31107034897, l.vandoorn@erasmusmc.nl
Calvin Brouwer, Msc, +31243098205, calvin.brouwer@radboudumc.nl
About this study
Official title: Systemic Treatment Related Toxicity Identified With a Smartphone APPlication Measuring Step Count - Prospective Cohort Study
The goal of this observational study is to investigate whether daily physical activities measured with a smartphone are related to the possible side effects or other physical complaints that arise as a result of cancer treatment. The investigators want to test whether the number of steps per day, both before and during treatment, are related to possible side effects or other physical complaints of the treatment using a smartphone. Knowledge about this relationship gives us possible starting points to prevent and/or reduce side effects and improve treatment outcomes. Additional research would then be needed.
The investigators also want to investigate whether these daily measurements are feasible for patients undergoing treatment.
Participation in the study involves measuring daily physical activity from the week before treatment until the first 3 months of treatment have been completed. This is done by tracking daily steps with patients own phone using the OncoSTAPP application.
Read the detailed description
Rationale: Systemic treatment of patients with cancer has a multimodal approach with the goal of balancing quantity and quality of life. Treatment decisions are influenced by tumour and patient-related characteristics. Additionally, in clinical practice performance status is used to identify whether a patient is sufficiently fit for systemic treatment, as it has shown to be a valid prognostic factor for survival and adverse events during treatment. However, treatment-related toxicities and hospitalisations occur frequently during systemic treatment.
The disadvantages of performance status assessed with ECOG or Karnofsky, is that it is a subjective measurement which is prone to bias and has high interobserver variability. Also a patient's self-reported physical function is significantly associated with shorter (progression-free) survival, but it is also subjective and is prone to multiple forms of bias. Objective assessment of physical function might be a good alternative to counteract these shortcomings. A higher level of physical activity is associated with a reduction in cancer specific mortality and can be measured with accelerometers, pedometers or multisenor systems like smartphones.
Wearable measured step count assessed with a wrist worn device provided by the investigators has shown to be associated with adverse events. However, these devices cannot be provided to all patients in clinical practice.
Recently, the investigators showed that the smartphones' assessments of physical activity (step count), have excellent agreement with accelerometer assessments of physical activity and good test-retest reliability. Furthermore this smartphone measurements were associated with early trial discontinuation in phase 1/2 cancer trials.
The investigators hypothesize that a low baseline and/or a reduction in physical activity (step count) measured with smartphones will be predictive for clinically relevant adverse events during systemic treatment. Adding objective information of physical function in the process of selecting the best treatment for a patient may help prevent unnecessary adverse events. Additionally, a detection of a decline in physical activity during treatment may identify upcoming adverse events early, allowing timely management/support. This may help to optimize treatment and quality of life.
Objective: Primary objectives: 1) To determine whether baseline physical activity, measured by the number of steps per day with a smartphone, is associated with clinically relevant adverse events during treatment.
- To determine whether changes in physical activity, measured by the number of steps per day with a smartphone, are associated with clinically relevant adverse events during treatment.
Clinically relevant adverse events during treatment are defined as hospitalizations, early treatment discontinuation, relative dose intensity below 70% and mortality.
Secondary: Patients' acceptability of the application. The association of physical activity with relative dose intensity, progression free and overall survival. The association between the oncologists' estimates and clinically relevant adverse events during treatment, and the possible added value of objective assessments of physical activity.
Study design: Prospective observational cohort study.
Study population: 411 patients with cancer referred for systemic treatment at the departments of Medical Oncology at participating centres.
Intervention: N/A.
Main study parameters/endpoints: Collection of daily number of steps will start in the week before treatment and will continue for the first 3 months of systemic treatment. Mean number of steps per day will be measured passively with a smartphone application on patients' own smartphones. Primary endpoint is any clinically relevant adverse events during treatment, defined as hospitalizations, significant dose modifications of treatment and mortality.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation in this study will not cause any additional risks or expected benefits for participants. No extra visits to the hospital will be necessary. It will provide us knowledge, which may be used in the future to better select patients for systemic treatment.
Patients will be asked to carry their smartphone on them during the duration of the study.
- Keywords
- Cancer, Systemic treatment, Toxicity, Physical activity, Smartphone, wearable, Daily step count
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study population | Patients with cancer referred for systemic treatment of the outpatient clinic at the departments of Medical Oncology at participating centres. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Mean number of steps per day measured with a smartphone. At baseline and during treatment
Measured: From enrollment to the end of observation period (90 days on systemic treatment)
Number of patients with a hospitalization
Hospitalizations during treatment related to the therapy; will be combined into Clinically relevant adverse events during treatment
Measured: From enrollment to the end of observation period (90 days on systemic treatment)
Number of patients with a treatment discontinuation
Early treatment discontinuation, within the first 3 months; will be combined into Clinically relevant adverse events during treatment
Measured: From enrollment to the end of observation period (90 days on systemic treatment)
Number of patients with a RDI <70%
Relative dose intensity (RDI) below 70%; will be combined into Clinically relevant adverse events during treatment
Measured: From enrollment to the end of observation period (90 days on systemic treatment)
Rate of mortality
Mortality due to treatment toxicity; will be combined into Clinically relevant adverse events during treatment
Measured: From enrollment to the end of observation period (90 days on systemic treatment)
Relative dose intensity (RDI) of systemic treatment
The percentage of planted dose and time between doses will be retrieved form patients' medical records (EPIC). The RDI will be calculated by total percentage of given dose divided by the proportion of the actual time in relation to the standard time. RDI=(Total percentage of given dose)/((Actual time)/(Standard time))*100
Measured: From enrollment to the end of observation period (90 days on systemic treatment)
Secondary outcomes (6)
Physician's rated performance status
The Eastern Cooperative Oncology Group/World Health Organization Performance Status (ECOG/WHO-PS) will be determined by the treating physician before treatment as stated in the current treatment guidelines of the departments of Medical Oncology. scale 0 to 5, with 0 denoting perfect health and 5 death.
Measured: At enrollment
Oncologists' estimates of high toxicity risk during treatment
Question if patients are defined as at high (>50%) or low risk of dose limiting (>25% or discontinuation) toxicity during the first 3 months of systemic treatment. This will be documented in patients' medical records (e.g. EPIC).
Measured: At enrollment
Overall survival
Overall survival is defined as the time between start of trial participation and death of any cause and will be tracked via the patients' medical records (e.g. EPIC).
Measured: From enrollment until the date of death from any cause, assessed up to 2 years
Progression free survival
Progression free survival is defined as the time between start of systemic treatment and the clinically or radiologically confirmation of progressive disease (established via RECIST-criteria) and will be tracked via the patients' medical records (e.g. EPIC).
Measured: From enrollment until the date of first documented progression assessed up to 2 years
Proportion of patients with correctly collected data
Validity of the smartphone application will be assesed by the proportion of patients correctly collected the data.
Measured: From enrollment to the end of observation period (90 days on systemic treatment)
Patients experience with smartphone application
A consecutive sample of patients will be contacted for a short interview about the use of the smartphone application, until data saturation. Any spontaneously reported reactions about the smartphone application will be collected.
Measured: At the end of the observation period (90 days on systemic treatment), or reported spontaniously by the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Sep 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Radboud University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 411 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, Medisch Centrum Leeuwarden
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927636
- Sponsor's protocol ID
- 2022-13469
- Acronym
- STAPPS
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: No current plans for data sharing. Patients gave informed consent to share data with studies in line with the current research question. Data availible on request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Treatment Related Toxicity Identified With a Smartphone APPlication Measuring Step Count - Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05927636
- Acronym / sponsor ID
- STAPPS / 2022-13469
- Keywords
- Cancer, Systemic treatment, Toxicity, Physical activity, Smartphone, wearable, Daily step count
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 411 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, Medisch Centrum Leeuwarden
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to investigate whether daily physical activities measured with a smartphone are related to the possible side effects or other physical complaints that arise as a result of cancer treatment. The investigators want to test whether the number of steps per day, both before and during treatment, are related to possible side effects or other physical complaints of the treatment using a smartphone. Knowledge about this relationship gives us possible starting points to prevent and/or reduce side effects and improve treatment outcomes. Additional research would then be needed.
The investigators also want to investigate whether these daily measurements are feasible for patients undergoing treatment.
Participation in the study involves measuring daily physical activity from the week before treatment until the first 3 months of treatment have been completed. This is done by tracking daily steps with patients own phone using the OncoSTAPP application.
Detailed description
Rationale: Systemic treatment of patients with cancer has a multimodal approach with the goal of balancing quantity and quality of life. Treatment decisions are influenced by tumour and patient-related characteristics. Additionally, in clinical practice performance status is used to identify whether a patient is sufficiently fit for systemic treatment, as it has shown to be a valid prognostic factor for survival and adverse events during treatment. However, treatment-related toxicities and hospitalisations occur frequently during systemic treatment.
The disadvantages of performance status assessed with ECOG or Karnofsky, is that it is a subjective measurement which is prone to bias and has high interobserver variability. Also a patient's self-reported physical function is significantly associated with shorter (progression-free) survival, but it is also subjective and is prone to multiple forms of bias. Objective assessment of physical function might be a good alternative to counteract these shortcomings. A higher level of physical activity is associated with a reduction in cancer specific mortality and can be measured with accelerometers, pedometers or multisenor systems like smartphones.
Wearable measured step count assessed with a wrist worn device provided by the investigators has shown to be associated with adverse events. However, these devices cannot be provided to all patients in clinical practice.
Recently, the investigators showed that the smartphones' assessments of physical activity (step count), have excellent agreement with accelerometer assessments of physical activity and good test-retest reliability. Furthermore this smartphone measurements were associated with early trial discontinuation in phase 1/2 cancer trials.
The investigators hypothesize that a low baseline and/or a reduction in physical activity (step count) measured with smartphones will be predictive for clinically relevant adverse events during systemic treatment. Adding objective information of physical function in the process of selecting the best treatment for a patient may help prevent unnecessary adverse events. Additionally, a detection of a decline in physical activity during treatment may identify upcoming adverse events early, allowing timely management/support. This may help to optimize treatment and quality of life.
Objective: Primary objectives: 1) To determine whether baseline physical activity, measured by the number of steps per day with a smartphone, is associated with clinically relevant adverse events during treatment.
- To determine whether changes in physical activity, measured by the number of steps per day with a smartphone, are associated with clinically relevant adverse events during treatment.
Clinically relevant adverse events during treatment are defined as hospitalizations, early treatment discontinuation, relative dose intensity below 70% and mortality.
Secondary: Patients' acceptability of the application. The association of physical activity with relative dose intensity, progression free and overall survival. The association between the oncologists' estimates and clinically relevant adverse events during treatment, and the possible added value of objective assessments of physical activity.
Study design: Prospective observational cohort study.
Study population: 411 patients with cancer referred for systemic treatment at the departments of Medical Oncology at participating centres.
Intervention: N/A.
Main study parameters/endpoints: Collection of daily number of steps will start in the week before treatment and will continue for the first 3 months of systemic treatment. Mean number of steps per day will be measured passively with a smartphone application on patients' own smartphones. Primary endpoint is any clinically relevant adverse events during treatment, defined as hospitalizations, significant dose modifications of treatment and mortality.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation in this study will not cause any additional risks or expected benefits for participants. No extra visits to the hospital will be necessary. It will provide us knowledge, which may be used in the future to better select patients for systemic treatment.
Patients will be asked to carry their smartphone on them during the duration of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | –Patients with cancer referred for systemic treatment of the outpatient clinic at the departments of Medical Oncology at participating centres. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with cancer referred for systemic treatment of the outpatient clinic at the departments of Medical Oncology at participating centres.
Key inclusion criteria (5 listed)
- Age ≥18 years;
- Diagnosis of cancer with an indication of starting systemic treatment
- Knowledge how to handle smartphone with iOS version 11 or higher or Android version 7.0 or higher.
- Mastery of Dutch language
- Able and willing to give written informed consent
Key exclusion criteria (3 listed)
- Cognitive disorders or severe emotional instability
- Wheelchair-depended at home, or immobile due to for example fracture
- Already participating in an exercise trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical activity
Time frame: From enrollment to the end of observation period (90 days on systemic treatment)
Mean number of steps per day measured with a smartphone. At baseline and during treatment
Number of patients with a hospitalization
Time frame: From enrollment to the end of observation period (90 days on systemic treatment)
Hospitalizations during treatment related to the therapy; will be combined into Clinically relevant adverse events during treatment
Number of patients with a treatment discontinuation
Time frame: From enrollment to the end of observation period (90 days on systemic treatment)
Early treatment discontinuation, within the first 3 months; will be combined into Clinically relevant adverse events during treatment
Number of patients with a RDI <70%
Time frame: From enrollment to the end of observation period (90 days on systemic treatment)
Relative dose intensity (RDI) below 70%; will be combined into Clinically relevant adverse events during treatment
Rate of mortality
Time frame: From enrollment to the end of observation period (90 days on systemic treatment)
Mortality due to treatment toxicity; will be combined into Clinically relevant adverse events during treatment
Relative dose intensity (RDI) of systemic treatment
Time frame: From enrollment to the end of observation period (90 days on systemic treatment)
The percentage of planted dose and time between doses will be retrieved form patients' medical records (EPIC). The RDI will be calculated by total percentage of given dose divided by the proportion of the actual time in relation to the standard time. RDI=(Total percentage of given dose)/((Actual time)/(Standard time))*100
6 secondary outcomes
Physician's rated performance status
Time frame: At enrollment
Oncologists' estimates of high toxicity risk during treatment
Time frame: At enrollment
Overall survival
Time frame: From enrollment until the date of death from any cause, assessed up to 2 years
Progression free survival
Time frame: From enrollment until the date of first documented progression assessed up to 2 years
Proportion of patients with correctly collected data
Time frame: From enrollment to the end of observation period (90 days on systemic treatment)
Patients experience with smartphone application
Time frame: At the end of the observation period (90 days on systemic treatment), or reported spontaniously by the patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Website with patient information in dutchLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. No current plans for data sharing. Patients gave informed consent to share data with studies in line with the current research question. Data availible on request.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Systemic Treatment, run by Radboud University Medical Center at 3 sites in Netherlands.
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 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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 Laurien Buffart, PhD (+31243613674, laurien.buffart@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: From enrollment to the end of observation period (90 days on systemic treatment)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.