Feasibility of Wearable Activity Trackers for Detection of TOXicity in People Receiving Systemic Anticancer Treatment

NCT04440800 | Unknown

• 1 other identifier: CCR5083
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lung Cancer, Small Cell; Pancreatic Cancer; Gastric Cancer; Oesophageal Cancer; Lung Cancer, Nonsmall Cell; Lung Cancer Metastatic

Outcome Measures

Primary Outcomes (2)

• Feasibility of monitoring reductions in step count in people with advanced lung cancer or upper gastrointestinal cancers starting systemic anti-cancer therapy.

  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.

  Analysis 4 months after last patient recruited

• Feasibility of undertaking a timely ambulatory review, of participants in whom a reduction of steps is detected

  Feasibility of a timely ambulatory review will be determined by measuring the proportion of participants who are invited for an ambulatory review and attend within 24 hours. If 70% of participants invited for a review attend, this will be considered feasible.

  Analysis 4 months after last patient recruited

Secondary Outcomes (6)

• Participant compliance with use of activity monitor

  Analysis 4 months after last patient recruited

• Utility of monitoring steps counts as a trigger for ambulatory assessment for the identification of new or worsening adverse events in people with cancer.

  Analysis 4 months after last patient recruited

• Sensitivity of monitoring steps counts for the identification of new or worsening adverse events in people with cancer

  Analysis 4 months after last patient recruited

• Number of hospitalisation episodes.

  Analysis 4 months after last patient recruited

• Proportion of hospitalisation episodes associated with WAT-triggered ambulatory reviews.

  Analysis 4 months after last patient recruited

Other Outcomes (2)

• Correlation between steps count, physician assessed WHO performance status (PS), quality of life (QoL) and muscle mass/attenuation/function

  Analysis 4 months after last patient recruited

• Correlation between resting heart rate, hospitalisation and muscle mass/attenuation/function

  Analysis 4 months after last patient recruited

Study Arms (1)

Study participants

All patients will receive the intervention

Device: Wearable activity tracker - FitBit

Interventions

Wearable activity tracker - FitBit DEVICE

Participants will be given a wearable activity tracker and their daily step count recorded. If there is a reduction from baseline of over 1000 steps, the participant will be contacted and an ambulatory review organised if the reduction is not due to a device compliance issue

Study participants

Eligibility Criteria

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

Study Population

The participant population whose data will be subjected to the study analysis includes registered patients for whom baseline median daily step count was available and who were compliant with wearing the device during the follow up.

You may qualify if:

• 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.
• or more previous lines of treatment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden NHS Foundation Trust - London and Surrey

London, SM2 5PT, United Kingdom

Location

Related Publications (5)

• Ohri 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 BACKGROUND

• Gresham 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 BACKGROUND

• Prince 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 BACKGROUND

• Bennett 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 BACKGROUND

• Spruit 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 BACKGROUND

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Pancreatic Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases

Study Officials

• Nadia Yousaf

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bianca Peet

CONTACT

+44 0208 642 6011; Bianca.Peet@rmh.nhs.uk

Agnieszka Yongue

CONTACT

+44 0208 642 6011; Agnieszka.Yongue@rmh.nhs.uk

Study Design

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

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: June 22, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)