Systemic Treatment Related Toxicity Identified With a Smartphone APPlication Measuring Step Count

NCT05927636 | Unknown

• 1 other identifier: 2022-13469
• Study Type: observational
• Target: 411
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer; Systemic Treatment; Physical Activity; Toxicity Due to Chemotherapy

Keywords

Cancer; Systemic treatment; Toxicity; Physical activity; Smartphone; wearable; Daily step count

Outcome Measures

Primary Outcomes (6)

• Physical activity

  Mean number of steps per day measured with a smartphone. At baseline and during treatment

  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

  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

  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

  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

  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

  From enrollment to the end of observation period (90 days on systemic treatment)

Secondary Outcomes (6)

• Physician's rated performance status

  At enrollment

• Oncologists' estimates of high toxicity risk during treatment

  At enrollment

• Overall survival

  From enrollment until the date of death from any cause, assessed up to 2 years

• Progression free survival

  From enrollment until the date of first documented progression assessed up to 2 years

• Proportion of patients with correctly collected data

  From enrollment to the end of observation period (90 days on systemic treatment)

Other Outcomes (23)

• Patient characteristics, age

  at enrolement

• Patient characteristics, weight

  at enrolement

• Patient characteristics, heigth

  at enrolement

Study Arms (1)

Study population

Patients with cancer referred for systemic treatment of the outpatient clinic at the departments of Medical Oncology at participating centres.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Cognitive disorders or severe emotional instability
• Wheelchair-depended at home, or immobile due to for example fracture
• Already participating in an exercise trial

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Erasmus Medical Center: collaborator
• Medisch Centrum Leeuwarden: collaborator

Study Sites (3)

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

RECRUITING

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

RECRUITING

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

NOT YET RECRUITING

Related Links

• Website with patient information in dutch

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Laurien Buffart, PhD

CONTACT

+31243613674; laurien.buffart@radboudumc.nl

Calvin Brouwer, Msc

CONTACT

+31243098205; calvin.brouwer@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: July 3, 2023
• Study Start: September 1, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Till 15 years from start data collection
• Access Criteria: Research question in line with current

Locations

NL (3)