Clinical trial NCT05927636: Systemic Treatment Related Toxicity Identified With a Smartphone APPlication Measuring Step Count
Official title: Systemic Treatment Related Toxicity Identified With a Smartphone APPlication Measuring Step Count - Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Systemic Treatment
Physical Activity
Toxicity Due to Chemotherapy
Keywords: Cancer
Systemic treatment
Toxicity
Physical activity
Smartphone
wearable
Daily step count
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: Medisch Centrum Leeuwarden
First posted: 2023-07-03
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with cancer referred for systemic treatment of the outpatient clinic at the departments of Medical Oncology at participating centres.

Brief 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.

Eligibility 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

Primary outcomes:
measure: Physical activity
timeFrame: From enrollment to the end of observation period (90 days on systemic treatment)
measure: Number of patients with a hospitalization
timeFrame: From enrollment to the end of observation period (90 days on systemic treatment)
measure: Number of patients with a treatment discontinuation
timeFrame: From enrollment to the end of observation period (90 days on systemic treatment)
measure: Number of patients with a RDI <70%
timeFrame: From enrollment to the end of observation period (90 days on systemic treatment)
measure: Rate of mortality
timeFrame: From enrollment to the end of observation period (90 days on systemic treatment)
measure: Relative dose intensity (RDI) of systemic treatment
timeFrame: From enrollment to the end of observation period (90 days on systemic treatment)
Secondary outcomes:
measure: Physician's rated performance status
timeFrame: At enrollment
measure: Oncologists' estimates of high toxicity risk during treatment
timeFrame: At enrollment
measure: Overall survival
timeFrame: From enrollment until the date of death from any cause, assessed up to 2 years
measure: Progression free survival
timeFrame: From enrollment until the date of first documented progression assessed up to 2 years
measure: Proportion of patients with correctly collected data
timeFrame: From enrollment to the end of observation period (90 days on systemic treatment)
measure: Patients experience with smartphone application
timeFrame: At the end of the observation period (90 days on systemic treatment), or reported spontaniously by the patient
Other outcomes:
measure: Patient characteristics, age
timeFrame: at enrolement
measure: Patient characteristics, weight
timeFrame: at enrolement
measure: Patient characteristics, heigth
timeFrame: at enrolement
measure: Patient characteristics, comorbidities
timeFrame: at enrolement
measure: Patient characteristics, tumour
timeFrame: at enrolement
measure: Patient characteristics, previous treatment
timeFrame: at enrolement
measure: Patient characteristics, treatment
timeFrame: at enrolement
measure: Patient characteristics, number of medication
timeFrame: at enrolement
measure: Patient characteristics, Hemoglobin
timeFrame: at enrolement
measure: Patient characteristics, Leukocytes
timeFrame: at enrolement
measure: Patient characteristics, Trombocytes
timeFrame: at enrolement
measure: Patient characteristics, Neutrophils
timeFrame: at enrolement
measure: Patient characteristics, Lymphocytes
timeFrame: at enrolement
measure: Patient characteristics, Sodium
timeFrame: at enrolement
measure: Patient characteristics, Urea
timeFrame: at enrolement
measure: Patient characteristics, Creatinine
timeFrame: at enrolement
measure: Patient characteristics, Creatinine clearance
timeFrame: at enrolement
measure: Patient characteristics, Alanine aminotransferase
timeFrame: at enrolement
measure: Patient characteristics, Aspartate aminotransferase
timeFrame: at enrolement
measure: Patient characteristics, Serum Lactate Dehydrogenase
timeFrame: at enrolement
measure: Patient characteristics, Alkaline phosphatase
timeFrame: at enrolement
measure: Patient characteristics, Serum Albumin
timeFrame: at enrolement
measure: Patient characteristics, C-reactive protein
timeFrame: at enrolement
Locations:
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
state: Friesland
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
References: