UMIN-ICDS Clinical Trial

Public title

Monitoring of Adverse Event for Anticancer Drugs Using Mobile Healthcare

Acronym

Monitoring of Adverse Event for Anticancer Drugs Using Mobile Healthcare

Scientific Title

Monitoring of Adverse Event for Anticancer Drugs Using Mobile Healthcare

Scientific Title:Acronym

Monitoring of Adverse Event for Anticancer Drugs Using Mobile Healthcare

Region

Japan

Condition

Cancers

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

In this study, we collect real-world data on cancer patients undergoing anticancer drug treatment using a mobile healthcare application based on real-time vital information from wearable devices and subjective symptoms collected by the patients themselves in a web application, and investigate the association between adverse events and adverse events.

Basic objectives2

Others

Basic objectives -Others

To investigate the detection rate of adverse events of anticancer therapy by mobile health care

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Detection rate of adverse events of anticancer therapy by mobile healthcare

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. patients with pathologically diagnosed cancer
2. patients who are scheduled to receive anticancer drug treatment
3. patients who are expected to have a prognosis of at least 6 months
4. patients whose consent to participate in this study has been obtained by signing a consent form by the patient himself/herself

Key exclusion criteria

1. patients who have received no anticancer therapy but only supportive or palliative therapy
2. patients with a prognosis predicted to be less than 6 months

Target sample size

40

Name of lead principal investigator

1st name	Takafumi
Middle name
Last name	Suda

Organization

Hamamatsu University School of Medicine

Division name

Second Division, Department of Internal Medicine

Zip code

431-3192

Address

1-20-1, Handayama, Hamamatsu

TEL

053-435-2263

Email

suda@hama-med.ac.jp

Name of contact person

1st name	Masato
Middle name
Last name	Karayama

Organization

Hamamatsu University School of Medicine

Division name

Cancer Center

Zip code

431-3192

Address

1-20-1, Handayama, Hamamatsu

TEL

053-435-2491

Homepage URL

Email

karayama@hama-med.ac.jp

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name

Organization

Pfizer Health Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The institutional review board of Hamamatsu University School of MedicineInstit

Address

1-20-1, Handayama, Hamamatsu

Tel

053-435-2680

Email

rinri@hama-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

03

Month

26

Day

Date of IRB

2023

Year

06

Month

09

Day

Anticipated trial start date

2023

Year

12

Month

01

Day

Last follow-up date

2026

Year

05

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Data collection:
Background: age, gender, medical history, complications, cancer type, cancer stage, cancer treatment history
Physical findings: height, weight, blood pressure, pulse, temperature, SpO2, ECOG-PS
Wearable device data: heart rate, steps, calories burned, number of steps during exercise, duration of exercise, average heart rate during exercise, walking speed during exercise, distance traveled horizontally, number of times traveled, sleep data, resting heart rate, blood oxygen saturation, respiration rate
Subjective symptoms of web application: medication, blood pressure, weight, subjective symptoms, exercise findings, clinical course: details of anticancer drug, administration date, adverse events, questionnaire regarding application: satisfaction level, other comments freely stated

Registered date

2023

Year

11

Month

01

Day

Last modified on

2023

Year

11

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060112