UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000051589
Receipt number R000058859
Scientific Title Registry Study for Symptom Management and Monitoring By PHR APP in Routine Cancer Care Practice
Date of disclosure of the study information 2023/09/01
Last modified on 2024/04/02 17:47:17

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Basic information

Public title

Registry Study for Symptom Management and Monitoring By PHR APP in Routine Cancer Care Practice

Acronym

Registry Study for Symptom Management and Monitoring By PHR APP in Routine Cancer Care Practice

Scientific Title

Registry Study for Symptom Management and Monitoring By PHR APP in Routine Cancer Care Practice

Scientific Title:Acronym

Oncology PHR Registry

Region

Japan


Condition

Condition

Cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The registry will evaluate the feasibility and usefulness of symptom monitoring using a Personal Health Record (PHR) application in the daily treatment of cancer. It will also accumulate real world data (RWD) of adverse events and quality of life (QOL) based on patient assessments in routine cancer care, and construct a dataset that can be utilized in various situations.

Basic objectives2

Others

Basic objectives -Others

Registry Research

Trial characteristics_1

Others

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Feasibility of the use of PHR application

Key secondary outcomes

Frequency of adverse events assessed by PRO-CTCAE by cancer type and treatment
Change in quality of life (EORTC-C30) over time by cancer type and treatment
Usefulness of PHR application
Extent, satisfaction, and usefulness of information assessed by EORTC QLQ - INFO25


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Diagnosed with a malignant tumor
2) 18 years of age or older at the time consent is obtained
3) Use or plan to use a PHR application for symptom management
4) Consent to participate in the study has been obtained in writing or electronically

Key exclusion criteria

1) Patients who have obvious difficulty using the PHR application (with or without assistance from family, staff, etc.)
2) Patients who clearly have difficulty assessing their own symptoms due to psychiatric disorders or cognitive dysfunction.

Target sample size

5000


Research contact person

Name of lead principal investigator

1st name Yasushi
Middle name
Last name Goto

Organization

National Cancer Center Hospital

Division name

Department of Thoracic Oncology

Zip code

104-0045

Address

Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045 JAPAN

TEL

03-3542-2511

Email

ygoto@ncc.go.jp


Public contact

Name of contact person

1st name Reiko
Middle name
Last name Makihara

Organization

National Cancer Center Hospital

Division name

Department of Pharmacy

Zip code

104-0045

Address

Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045 JAPAN

TEL

03-3542-2511

Homepage URL


Email

reando@ncc.go.jp


Sponsor or person

Institute

National Cancer Center

Institute

Department

Personal name



Funding Source

Organization

National Cancer Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Tokyo


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Ethics Committee at National Cancer Center

Address

2-11-12-403 Tomigaya, Shibuya, Tokyo, Japan

Tel

03-3542-2511

Email

irst@ml.res.ncc.go.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

国立がん研究センター中央病院(東京都)
相良病院(鹿児島県)
小松市民病院(石川県)
竹田綜合病院(福島県)


Other administrative information

Date of disclosure of the study information

2023 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2023 Year 04 Month 28 Day

Date of IRB

2024 Year 02 Month 13 Day

Anticipated trial start date

2024 Year 04 Month 01 Day

Last follow-up date

2028 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The healthcare provider reviews the symptom information recorded by the patient in the PHR application before or during the consultation. The healthcare provider also uses this information to examine the patient during the consultation, and provides necessary information and guidance. The operation method of symptom monitoring using the PHR application by medical institutions shall be conducted in accordance with the "Welby My Chart ONC "PRO" Welby PRO Connect Specification Manual for Medical Institutions.


Management information

Registered date

2023 Year 07 Month 12 Day

Last modified on

2024 Year 04 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058859