Clinical trial · Observational
Feasibility of Wearable Activity Trackers for Detection of TOXicity in People Receiving Systemic Anticancer Treatment
Remote Monitoring of Wearable Activity Trackers for Detection of TOXicity in People Receiving Systemic Anticancer Treatment: a Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Lung Cancer Metastatic | — | UNRESOLVED | — |
| Lung Cancer, Nonsmall Cell | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Lung Cancer, Small Cell | Lung Small Cell Carcinoma | ALIAS | 0.90 |
| Oesophageal Cancer | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Wearable activity tracker - FitBit | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study participants
- description
- All patients will receive the intervention
- interventionNames
- Device: Wearable activity tracker - FitBit
Primary outcomes (2)
- measure
- Feasibility of monitoring reductions in step count in people with advanced lung cancer or upper gastrointestinal cancers starting systemic anti-cancer therapy.
- timeFrame
- Analysis 4 months after last patient recruited
- description
- 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.
- measure
- Feasibility of undertaking a timely ambulatory review, of participants in whom a reduction of steps is detected
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (5)
- BACKGROUNDOhri 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. PMID 28332990
- BACKGROUNDGresham 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. PMID 31304309
- BACKGROUNDPrince 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. PMID 30238542
- BACKGROUNDBennett 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. PMID 26577763
- BACKGROUNDSpruit 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. PMID 23958225