Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Mitogens

Palbociclib

As a low-interventional procedure, enrolled patients will be provided with wearable device and requested to wear the device at all-times, except of while bathing and sleeping, for 6 cycles (24 weeks).

Wearable device

Pfizer CT.gov Call Center

Hiroko Bando

The study is a prospective, multicenter, observational study to evaluate PRO and physical activity using smartphone-based application and wearable device in Japanese patients with HR+/HER2- advanced breast cancer (ABC).

Patients will be enrolled into either palbociclib plus endocrine therapy group (Group 1) or endocrine monotherapy group (Group 2) based on the discretion of the treating physician under routine clinical practice. Total target number of patients is approximately one-hundred in this study (About 50 patients in each group).

Enrolled patients will download a smartphone-based application for electronic PRO (ePRO), be provided access to and trained on the use of the application to complete baseline, weekly, and cycle-based assessments for 6 cycles (24 weeks). In addition, enrolled patients will be provided with wearable device and requested to wear the device at all-times, except of while bathing and sleeping, for 6 cycles (24 weeks).

Study to Evaluate Patient Reported Outcome (PRO) and Physical Activity in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy

Prospective, Multicenter, Observational Study to Evaluate Patient-reported Outcome and Physical Activity Using Smartphone-based Application and Wearable Device in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

EORTC-QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties).

Physical activity metrics (eg, sedentary time) will be derived by Actigraph's algorithms based on the raw data collected by the device

PRO-CTCAE: seventy-eight symptom terms that are common in oncology clinical trials can be evaluable, and each of symptom terms is assessed relative to one or more distinct attributes, including frequency, severity, and/or interference with usual or daily activities.

Treatment satisfaction will be evaluated with single item question

Japan Breast Cancer Research Group (JBCRG)

Pfizer

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)

Wearable activity monitor

Gillian Gresham, PhD

Eileen Liu

Stephen Freedland, PhD

BJ Rimel, MD

Brennan Spiegel, MD

Jun Gong, MD

Arash Asher, MD

Andrew Hendifar, MD

Christine Walsh, MD

Edwin Posadas, MD

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.

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.

Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients

Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients: A Single Cohort, Prospective Trial

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

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.

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.

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.

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

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).

Cedars-Sinai Medical Center

Principal Investigator

Symptoms and General Pathology

Wounds and Injuries

Blood and Lymph Conditions

Rare Diseases

Hyperthermia

Neutropenia

Fever

Febrile Neutropenia

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Granulocytopenia

The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene.

The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.

Everion

Eva Brack, MD-PhD

Christa Koenig, MD

In this pilot study the feasibility of continous monitoring of health data with a small, on-skin wearable device (the Everion®, by Biovotion, Zurich) in pediatric patients under chemotherapy for cancer, is studied. Feasibility is assessed by the number of patients wearing the device on seven consecutive days for at least 18h/day, what will be measured by monitored heart rate. Study duration for each participant is 14 days.

No study has proved feasibility of continuous monitoring of health data with a small wearable device such as the device Everion® in pediatric patients. It is not known if children tolerate the device and if data quality sustains with smaller arm circumferences or when worn on the upper leg. Neither is it known if parents and/or patients can and are willing to handle the device in ambulant setting. Therefore, this pilot study assesses the feasibility of continous monitoring of health data with a small, on-skin wearable device (the Everion®, by Biovotion, Zurich) in pediatric patients under chemotherapy for cancer.

Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy

Continuous Monitoring of Health Data With a Wearable Device in Pediatric Patients Undergoing Chemotherapy for Cancer - a Feasibility Pilot Study

The coded study data (from the WD and clinical data) will be uploaded to figshare and made publically available for other researchers.

The primary outcome is defined as at least acceptable (≥50) quality score (worst quality 0, best quality 100) of heart rate during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).

At least acceptable (≥50) quality score (worst quality 0, best quality 100) of oxygen saturation during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).

At least acceptable(≥50) quality score (worst quality 0, best quality 100) of respiration rate during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).

At least acceptable(≥50) quality score (worst quality 0, best quality 100) of core temperature during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).

At least acceptable (≥50) quality score (worst quality 0, best quality 100) of heart rate variability during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).

At least acceptable (≥50) quality score (worst quality 0, best quality 100) of perfusion index during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).

Cumulative length of time with monitored heart rate with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).

Cumulative length of time with monitored oxygen saturation with at least acceptable quality score (≥50 worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).

Cumulative length of time with monitored respiration rate with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).

Cumulative length of time with monitored core temperature with at least acceptable quality score (≥50, worst quality 0, best quality 100)) per study day (continuous outcomes, measured daily).

Cumulative length of time with monitored heart rate variability with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).

Cumulative length of time with monitored perfusion index with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).

Proportion of patients and parents indicating that continuous monitoring with the wearable device (WD) is acceptable per day and per entire study duration and reasons not to wear the device.

Number and description of side effects reported by parents and patients, if applicable. Assessed with questionnaires.

Effort (cumulative number of contacts) for the Investigators.

Effort (cumulative duration of contacts) for the Investigators.

Difference between discrete measurements performed for clinical routine cares of heart rate and the mean of continuously measured heart rate within +/-10min at times of the discrete measurement.

Exploration of potential changes in or specific patterns of all collected signals and their quality scores in combination (heart rate, oxygen saturation, respiration rate, core temperature, skin temperature, heart rate variability, perfusion index, health score (0-100, higher score means better health), galvanic skin response) , within 48 hours before and after clinical diagnosis of fever (ear temperature of ≥39.0°C, or ≥38.5°C if fever is declared for clinical reasons) with or without neutropenia and microbiologically or clinically defined infections, if applicable.

Insel Gruppe AG, University Hospital Bern

The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene.

Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.

Everion®

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Switzerland

Region of Enrollment

Acute lymphoblastic leukemia

Other hematologic malignancies

Central nervous system tumor

Solid tumor

Type of malignancy

(i) The WDs were studied for only 14 days and compliance might be different during long-term use.

(ii) The small number of patients precluded an analysis of patient factors (iii) The planned comparison of discrete measurements versus continuously was not feasible because the exact second-wise time point of discrete measurements was not available.

Dr. med. Christa König

Feasibility of Continous Monitoring of Heart Rate With the Wearable Device (WD)

Continous Monitoring of Oxygen Saturation With the WD

Continous Monitoring of Respiration Rate With the WD

Continous Monitoring of Core Temperature With the WD

Continous Monitoring of Heart Rate Variability With the WD

Continous Monitoring of Perfusion Index With the WD

Cumulative Time of Monitoring Heart Rate With the WD

Cumulative Time of Monitoring Oxygen Saturation With the WD

Cumulative Time of Monitoring Respiration Rate With the WD

Cumulative Time of Monitoring Core Temperature With the WD

Cumulative Time of Monitoring Heart Rate Variability With the WD

Cumulative Time of Monitoring Perfusion Index With the WD

Device Acceptance Assessed With Questionnaires

Superficial skin lesion

irritated skin

itching

sweating

Number and Description of Side Effects

Effort for Investigators Assessed by Number of Contacts

Effort for Investigators Assessed by Duration of Contacts

The analysis of differences between discrete measurements and continuously recorded aggregates of vital signs, as defined in the protocol, was found to yield massively distorted results because rapidly changing discretely measured vital signs were compared to aggregated means covering up to 20 min. We deliberately refrain from displaying these nonmeaningful results here.

Comparison

Episodes with fever

Episodes with Infection

The 4 episodes occured in 3 of these 20 patients. The other 17 patients had no episode with fever or infection.

Exploration of Patterns Within the Vital Signs Before Episodes With Fever or Infection

Overall Study

Physical activities will be monitored by wearable device. Patient-reported outcomes including distress, depression, physical activities and quality of life are going to be collected by questionnaires based on smartphone application and paper. The algorithm of distress screening will be developed with the analysis of patterns of physical activities.

Physical activities will be monitored by wearable device.

Wearable device (Fitbit Charge HR® or Fitbit Alta ®)

Distress monitoring is an important issue in cancer survivors. However, conventional distress screening is very difficult to perform. This study investigates the efficacy of wearable device as a tool of distress monitoring in breast cancer survivors.

Development of Distress Management Algorithms Using Mobile Device Based Health Logs in Breast Cancer Survivors

The results of distress screening questionnaire and patterns of physical activities are going to be compared. The association between those two data will be analyzed. Using data of physical activities, the prediction model of distress will be tested and validated.

Asan Medical Center

Clinical Assistant Professor

Infections

Communicable Diseases

Body Temperature Changes

* Routine clinical care, which includes, among others, discrete fever measurements using ear thermometers in case of clinical deterioration or suspected fever, at the discretion of patients where applicable, parents and the treating team
* Plus CFM with a CORE® WD running, with alerts being sent automatically to participants if the CFM detects an estimated core body temperature fulfilling the fever criterion of the respective study site (≥38.5°C or 39.0°C).

* Routine clinical care as in "With CFM alerts"
* Plus CFM with a CORE® WD running as in "With CFM alerts", but with alerts being sent only if a clinically dangerous temperature of ≥40.0°C is detected, which will very rarely be the case before fever is detected by routine clinical care.

Fever alerts are automated sent to participants if fever is detected

Automated fever alerts

Eva K Brack, MD, PhD

Roland Ammann, MD, Prof.

Eva K Brack, MD, MD-PhD

Roland Ammann, MD, Prof

In children and adolescents undergoing chemotherapy for cancer, fever in neutropenia (FN) is the most frequent potentially lethal complication of chemotherapy for cancer. Emergency hospitalization and empirical treatment with i.v. broad-spectrum antibiotics have reduced lethality from \>50% in certain high risk situations to \<1%. Fever without neutropenia is a further complication requiring emergency evaluation and often emergency treatment.

Continuous monitoring of fever leads to earlier fever detection compared to the usual discrete fever measurements performed only for clinical reasons. Earlier detection of fever leads to earlier assessment and treatment and thus can reduce the risk of complications.

This study primarily aims to assess, in pediatric patients undergoing chemotherapy for cancer, the efficacy of automated fever alerts resulting from continuous fever monitoring (CFM) using a wearable device (WD), measured by the duration of intravenous antibiotics (i.v. AB) given for any cause.

Primary objective

The primary objective of this study is to determine if CFM fever alerts (CFM-FA) automatically sent by a WD reduce the duration of i.v. antibiotics application in children and adolescents treated with myelosuppressive chemotherapy for cancer.

Secondary objectives

Regarding safety

A. Number of fever episodes (FE) with safety relevant events (SREs)

B. Number of false alerts

C. Number of missed alarms

Regarding efficacy

D. Delay of chemotherapy application

E. Duration of antimicrobial application except i.v. antibiotics

F. Number of FEs diagnosed below or at temperature limit (TL) versus above TL

G. FEs according to chemotherapy intensity

H. WD measured core temperature at time of fever detection by ear thermometer

I. FEs reported outside TARs

J. Quality of life Questionnaire

K. Assessment of the side-effects of the WD

Tertiary objective

L. Comparison of continuously recorded core temperature of the WD with results of discrete measurements of tympanic temperature

M. Pattern search using data mining

Prospective interventional, multi-center, double-blinded, randomized controlled, multiple crossover superiority trial

Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients

Swiss 2024 Fever Monitoring Study: An Double-blinded, Randomized Controlled Multiple Crossover Superiority Trial on Continuous Fever Monitoring in Paediatric Patients With Cancer at Risk for Fever in Neutropenia

Publication in international journal of study protocol and results

Difference between discrete measurements of core temperature

Exploration of potential changes in or specific patterns of all measured temperature signals within 48 hours before clinical diagnosis of fever

The cumulative duration of i.v. antibiotics applied

Duration of delay of chemotherapy application in days

Duration of antimicrobial application except i.v. antibiotics

Number of FEs diagnosed below or at TL versus above TL

Amount of fever episodes according to chemotherapy intensity

WD measured core temperature at time of fever detection by ear thermometer

Amount of fever episodes reported outside TARs

Proportion of participants indicating that wearing a WDs is acceptable/unacceptable, not increasing anxiety/increasing anxiety, providing/not providing security, increase burden/effort or not

Side effects reported by participants, if applicable

ETH Zurich

Shabbir Syed-Abdul, PhD

Shabbir Syed Abdul

The purpose of this study is to develop a novel deep-learning-based survival prediction model employing patient activity data recorded by a wearable device.

This study aims to develop a deep-learning-based survival prediction model that utilizes patient movement data upon admission to predict their clinical outcomes: either death or discharge with stable condition. Objective data of the patients are recorded by a wearable device and documented as parameters of physical activity, angle, and spin. In addition to objective data, the investigators also document patients' Karnofsky Performance Status assessed subjectively by clinical doctors. Finally, the investigators aim to explore and describe the applicability, potential, and limitations of the survival prediction model based on patient movement data as a simple prognostic parameter in clinical settings.

Artificial Intelligence-based Mortality Prediction Among Cancer Patients in the Hospice Ward

Artificial Intelligence-based Activity Recognition and Mortality Prediction Using Circadian Rhythm, Among Cancer Patients in the Hospice Ward

The primary outcome of the study will be to evaluate whether the analysis of the movement data captured using actigraphy device can help to predict clinical outcomes either deceased or discharged alive from hospital, with a high specificity and sensitivity, using Artificial Intelligence based prediction modelling.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Evaluate Patient Reported Outcome (PRO) and Physical Activity in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy	NCT04736576	Breast Cancer	Wearable device	20 Years -	Pfizer
Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients	NCT03757182	Cancer Cancer, Metasta... Neoplasms	Wearable activi...	18 Years -	Cedars-Sinai Medical Center
Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy	NCT04134429	Pediatric Cance... Febrile Neutrop... Chemotherapy-in... Oncology	Everion	1 Month - 17 Years	Insel Gruppe AG, University Hospital Bern
Development of Distress Management Algorithms Using Mobile Device Based Health Logs in Breast Cancer Survivors	NCT03072966	Breast Cancer Quality of Life	Wearable device...	20 Years - 60 Years	Asan Medical Center
Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy	NCT04134429	Pediatric Cance... Febrile Neutrop... Chemotherapy-in... Oncology	Everion	1 Month - 17 Years	Insel Gruppe AG, University Hospital Bern
Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients	NCT05940766	Pediatric Oncol...	Automated fever...	1 Month - 17 Years	Insel Gruppe AG, University Hospital Bern
Artificial Intelligence-based Mortality Prediction Among Cancer Patients in the Hospice Ward	NCT04883879	End Stage Cance...		20 Years -	Taipei Medical University

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