Trial Title:
Systemic Treatment Related Toxicity Identified With a Smartphone APPlication Measuring Step Count
NCT ID:
NCT05927636
Condition:
Cancer
Systemic Treatment
Physical Activity
Toxicity Due to Chemotherapy
Conditions: Keywords:
Cancer
Systemic treatment
Toxicity
Physical activity
Smartphone
wearable
Daily step count
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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. 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.
2) 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.
Criteria for eligibility:
Study pop:
All patients with cancer referred for systemic treatment of the outpatient clinic at the
departments of Medical Oncology at participating centres.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Cognitive disorders or severe emotional instability
- Wheelchair-depended at home, or immobile due to for example fracture
- Already participating in an exercise trial
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Medisch Centrum Leeuwarden
Address:
City:
Leeuwarden
Zip:
8934 AD
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Joeri Douma, MD
Phone:
+31582866660
Email:
joeri.douma@mcl.nl
Contact backup:
Last name:
Calvin Brouwer, Msc
Phone:
+31243098205
Email:
calvin.brouwer@radboudumc.nl
Investigator:
Last name:
Joeri Douma, PhD
Email:
Principal Investigator
Facility:
Name:
Radboudumc
Address:
City:
Nijmegen
Zip:
6525GA
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Laurien Buffart, PhD
Phone:
+31243613674
Email:
laurien.buffart@radboudumc.nl
Contact backup:
Last name:
Calvin Brouwer, Msc
Phone:
+31243098205
Email:
calvin.brouwer@radboudumc.nl
Investigator:
Last name:
Evelien Kuip, MD
Email:
Principal Investigator
Investigator:
Last name:
Laurien Buffart
Email:
Principal Investigator
Facility:
Name:
Erasmus MC
Address:
City:
Rotterdam
Zip:
3015 GD
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Leni van Doorn
Phone:
+31107034897
Email:
l.vandoorn@erasmusmc.nl
Contact backup:
Last name:
Calvin Brouwer, Msc
Phone:
+31243098205
Email:
calvin.brouwer@radboudumc.nl
Investigator:
Last name:
Verheul Henk, Prof
Email:
Principal Investigator
Start date:
September 1, 2022
Completion date:
March 31, 2024
Lead sponsor:
Agency:
Radboud University Medical Center
Agency class:
Other
Collaborator:
Agency:
Erasmus Medical Center
Agency class:
Other
Collaborator:
Agency:
Medisch Centrum Leeuwarden
Agency class:
Other
Source:
Radboud University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05927636
https://www.radboudumc.nl/lopende-onderzoeken/stapps
