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- Essai clinique NCT03757182
Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients (DigiSTEPS)
30 mars 2022 mis à jour par: Gillian Gresham, Cedars-Sinai Medical Center
Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients: A Single Cohort, Prospective Trial
The purpose of this study is to examine the relationships between objectively measured physical activity and provider-assessed and patient-reported functional outcomes in patients with advanced cancer.
Findings from this study will help us better understand how change in daily physical activity, as measured using the wearable activity monitor, is related to change in a patient's functional status and clinical condition.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
Patients diagnosed with stage 3/ 4 cancer will be enrolled.
After providing informed consent, patients will be asked to wear a FitBit Charge HR continuously for 8 weeks with the option to continue wearing the monitor for up to a year after end-of-study.
Baseline assessments include a physical exam, medical history, and frailty assessment.
The attending oncologist will rate the patient's performance status (ECOG PS) at baseline and 8-weeks follow-up.
Patient-reported outcomes (self-reported physical function, fatigue, sleep, emotional distress) will be assessed weekly using NIH PROMIS from baseline up to 8 weeks from end-of-study.
They will also be collected at 1 year follow-up.
Wearable activity monitor data will be summarized each week for 8 weeks, and then again at 1 year follow-up.
Physical activity data (number of steps, stairs climbed, active minutes, heart rate, and sleep duration) will be collected and analyzed at end-of-study (up to 1 year from end-of-study).
Overall survival will also be assessed up to 1 year from end-of-study.
Absolute change in physical activity levels will be correlated with change in performance status and occurrence of AEs and death to better understand the role of remote activity monitoring in cancer patients.
Type d'étude
Observationnel
Inscription (Anticipé)
80
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
California
-
Los Angeles, California, États-Unis, 90048
- Recrutement
- Cedars-Sinai Medical Center
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Sous-enquêteur:
- Andrew Hendifar, MD
-
Sous-enquêteur:
- Edwin Posadas, MD
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Sous-enquêteur:
- Stephen Freedland, PhD
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Sous-enquêteur:
- BJ Rimel, MD
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Sous-enquêteur:
- Brennan Spiegel, MD
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Sous-enquêteur:
- Arash Asher, MD
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
Stage 3/4 advanced cancer patients being seen for treatment at Cedars-Sinai Medical Center.
La description
Inclusion Criteria:
- Diagnosis of advanced (stage 3 or 4) cancer of any type
- Ambulatory (use of walking aids, such as cane and rollator, is acceptable)
- Access to a device that has the capability to sync to the Fitbit
- Expected to have standard of care oncology appointments at least once every 8 weeks (+/-7 days).
- Have an understanding, ability, and willingness to fully comply with study procedures and restrictions
- English or Spanish speaking
- Ability to consent
- Informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Exclusion Criteria:
- Allergy to surgical steel or elastomer/rubber
- Using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment. However, removable hearing aids are permitted.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Wearable activity monitor
Continuous activity monitoring with Fitbit Charge HR from baseline to up to 1 year from end-of-study.
|
Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR)
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Absolute change in average step counts at 8 weeks from baseline
Délai: 8 weeks
|
Change will be calculated based on difference in average weekly step count at baseline from the average weekly step count at end-of-study visit
|
8 weeks
|
Absolute change in provider-assessed ECOG Performance Status at 8 weeks from baseline
Délai: 8 weeks
|
Change in performance status will be calculated based on difference in provider-assessed Eastern Cooperative Oncology Group (ECOG) performance status at end-of-study visit and baseline ECOG.
ECOG Performance Status is rated based on a 5-point scale where a score of 0 indicates best performance status and 5 indicates death.
Only one rating of ECOG PS by provider is completed at each timepoint.
|
8 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Absolute change in patient-reported physical function at 8 weeks from baseline
Délai: 8 weeks
|
Physical function will be assessed using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) short form, which includes 20 items and a range of 1 (low physical function) to 5 (high physical function).
The total score will be calculated and converted into a standardized t-score will be calculated based on a standard cancer population with a mean of 50 and SD of 10.
|
8 weeks
|
Patient weekly distress levels up to 8 weeks from baseline
Délai: 8 weeks
|
Distress will be measured using using NIH Patient-Reported Outcomes Measurement Information System (PROMIS), which includes short forms: emotional distress, sleep quality, pain, and fatigue.
Items range from 1 (worse outcome) and 5 (best outcome) where a total score will be calculated and converted into standardized t-scores.
|
8 weeks
|
Adherence to wearing the device for the specified study period
Délai: 8 weeks
|
A patient is considered adherent if they wear the device at least 10 hours per day for at least 4 of 7 days prior to each study timepoint
|
8 weeks
|
Change in frailty status from baseline to end-of-study visit (up to 8 weeks from baseline)
Délai: 8 weeks
|
Score calculated based on total number of frailty characteristics present using Fried's validated Frailty index.
Characteristics of frailty include shrinking (weight loss), weakness (grip strength), poor endurance, exhaustion, slowness, and low activity.
The minimal score is 0, indicating absence of frailty, and the highest is 5. Frailty index categories include absence of frailty (score of 0), pre-frail or intermediate frail (1-2 criteria) and frail (>3 criteria present).
|
8 weeks
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Occurrence of grade 3 or 4 SOC cancer-related adverse events or chemotoxicities and hospitalizations occurring from baseline up to 12 weeks
Délai: up to 12 weeks
|
AEs will be rated using CTCAE v5
|
up to 12 weeks
|
Overall survival up to 1 year from end-of-study
Délai: up to 1 year
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Occurrence of death from any cause
|
up to 1 year
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
5 décembre 2018
Achèvement primaire (Anticipé)
31 décembre 2022
Achèvement de l'étude (Anticipé)
31 décembre 2022
Dates d'inscription aux études
Première soumission
26 novembre 2018
Première soumission répondant aux critères de contrôle qualité
27 novembre 2018
Première publication (Réel)
28 novembre 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
31 mars 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 mars 2022
Dernière vérification
1 mars 2022
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- IIT2018-19-GRESH-DIGISTEP
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Indécis
Description du régime IPD
IPD available upon request.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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