Evidence map›Paper›PMID 33236210›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2021

Smartphone measurements of physical activity and fitness are associated with early trial discontinuation of patients in (hemato)oncology phase I/II clinical trials.

Joeri A J Douma, Sonja Zweegman, Mieke Alberts, Sandy Kruyswijk, Niels C W J van de Donk, Myra van Linde, Laurien M Buffart, Henk M W Verheul

Abstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Joeri A J DoumaDepartment of Medical Oncology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, De Boelelaan 1117, Amsterdam, The Netherlands.
Sonja ZweegmanDepartment of Hematology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, De Boelelaan 1117, Amsterdam, The Netherlands.
Mieke AlbertsDepartment of Medical Oncology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, De Boelelaan 1117, Amsterdam, The Netherlands.
Sandy KruyswijkDepartment of Hematology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, De Boelelaan 1117, Amsterdam, The Netherlands.
Niels C W J van de DonkDepartment of Hematology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, De Boelelaan 1117, Amsterdam, The Netherlands.
Myra van LindeDepartment of Medical Oncology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, De Boelelaan 1117, Amsterdam, The Netherlands.
Laurien M BuffartDepartment of Physiology, Radboudumc, Geert Grooteplein 10, Nijmegen, The Netherlands.
Henk M W VerheulDepartment of Medical Oncology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, De Boelelaan 1117, Amsterdam, The Netherlands. henk.verheul@radboudumc.nl.ORCID http://orcid.org/0000-0001-5981-922X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients, who discontinue early, do not benefit from phase I/II clinical trials (early-phase clinical trials (EPCT)). In this study, associations between objective smartphone measurements of physical activity and fitness and early trial discontinuation in patients with cancer participating in EPCT were investigated.

methodsBefore start of treatment, physical activity (steps/day) and physical fitness (meters walked in 6 min) were measured with a smartphone, and patient-reported physical function (PRO-PF) was assessed (EORTC QLQ-C30-PF). Early trial discontinuation was defined as discontinuation ≤ 28 days. Univariable logistic regression analyses were performed to study associations of physical activity, fitness, and function with early trial discontinuation. Optimal cutoff values of physical activity and fitness were assessed with ROCs, based on positive predictive values (PPV).

resultsMedian (interquartile range (IQR)) step count was 4263 (2548-6897) steps/day, mean ± standard deviation 6-min walking distance was 477 ± 120 m and median (IQR) PRO-PF score was 83 (67-95) points. Fourteen patients (12%) discontinued the trial early. Smartphone measurements of physical activity in units of 100 steps per day (odds ratio (OR) = 0.96, 95% CI = 0.94-0.99, p = 0.01), physical fitness (OR = 0.99, 95% CI = 0.98-0.99, p < 0.01), and PRO-PF (OR = 0.97, 95% CI = 0.94-1.00, p = 0.03) were associated with early trial discontinuation. Optimal cutoff values were < 900 steps for physical activity and < 285 m for physical fitness. PPV for early trial discontinuation was 100% in patients who walked both < 1500 steps per day and < 300 m in 6 min.

conclusionsObjective smartphone measurements of physical activity and fitness are associated with early trial discontinuation. However, cutoff values should be externally validated in a larger cohort before implementation in clinical practice.

Indexed as

Cohort StudiesExerciseFemaleHumansMaleMiddle AgedNeoplasmsPhysical FitnessSmartphoneEarly trial discontinuationPhysical activityPhysical fitnessSmartphone measurements

Identifiers

PMID33236210
PMCPMC8163675

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.