UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042447
Receipt number R000048457
Scientific Title Multicenter, Open-label, Randomized Comparative Study to Verify the Usefulness of Monitoring of Electronic Patient Reported Outcome (ePRO) in Patients with Unresectable Advanced Cancers and Metastasized or Relapsed Solid Tumors(PRO-MOTE)
Date of disclosure of the study information 2020/11/13
Last modified on 2023/04/17 15:04:38

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Basic information

Public title

Multicenter, Open-label, Randomized Comparative Study to Verify the Usefulness of Monitoring of Electronic Patient Reported Outcome (ePRO) in Patients with Unresectable Advanced Cancers and Metastasized or Relapsed Solid Tumors (PRO-MOTE)

Acronym

PRO-MOTE

Scientific Title

Multicenter, Open-label, Randomized Comparative Study to Verify the Usefulness of Monitoring of Electronic Patient Reported Outcome (ePRO) in Patients with Unresectable Advanced Cancers and Metastasized or Relapsed Solid Tumors(PRO-MOTE)

Scientific Title:Acronym

PRO-MOTE

Region

Japan


Condition

Condition

Unresectable Advanced Cancers and Metastasized or Relapsed Solid Tumors(Breast cancer, lung cancer, stomach cancer, colon cancer, squamous cell carcinoma of the head and neck, liver cancer, endometrial cancer, ovarian cancer)

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology Breast surgery Obstetrics and Gynecology
Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To verify the hypothesis that adding ePRO monitoring to standard care is useful for prolonging OS or maintaining or improving HRQoL in patients with unresectable advanced cancers and metastasized or relapsed solid tumors who are receiving systemic pharmacotherapy.

Basic objectives2

Others

Basic objectives -Others

Verify

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

(1) OS
(2) HRQoL
The global health status score on the The European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30) at all measurement time points to Week 24 after enrollment

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

[Monitoring arm]
ePRO monitoring will be conducted once weekly after study enrollment. The monitoring will concern treatment of each predefined type of cancer or characteristic symptoms of the condition. PRO-CTCAE (Patient-Reported Outcome-Common Terminology Criteria for Adverse Events) will be used as the scale for monitoring symptoms. The patient and (sub)investigator will share the monitoring results during examinations and use them to determine treatment strategies, etc. Threshold values will be predefined for a diagnosis of "severe" for individual symptoms. When it is reported that a threshold value has been exceeded, an alert notification will be sent to the study staff member assigned to the patient. The (sub)investigator who receives the notification will assess the information in the notification and take the best course of action.

Interventions/Control_2

[Control arm]
Standard care will be given.

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) Unresectable, advanced, metastasized, or relapsed solid tumors
(2) Expected to be able to undergo treatment or observation for at least 6 months at the study site
(3) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2
(4) Receiving systemic anticancer mono- or combination pharmacotherapy (e.g., cytotoxic anticancer agents, molecularly targeted drugs, and immune checkpoint inhibitors) at enrollment or scheduled to begin such therapy within 1 month from the date of enrollment
(In principle, patients should be receiving pharmacotherapy on an out-patient basis.)
(5) Capable of using electronic device (includes cases needing some assistance)
(6) Aged >=18 at informed consent
(7) Written consent for the study personally obtained from the subject

Key exclusion criteria

(1) Has undergone four or more regimens of pharmacotherapy for advanced, metastasized, or relapsed solid tumors*Notes 1, 2
(2) Currently participating in a study where PRO is tracked and the results are passed on to a physician
(3) The following are exclusion criteria for individual types of cancer
1) Breast cancer
- Scheduled to receive or currently receiving endocrine therapy (including endocrine therapy in combination with other agents) for hormone receptor-positive breast cancer
- Scheduled to receive or currently receiving first regimen of anti-HER2 therapy for HER2-positive disease
2) Liver cancer
- Hepatic function of Child-Pugh B/C
(4) Ongoing or planned radical radiotherapy
(5) Deemed otherwise unsuitable for the study by the investigator or sub-investigator
*Notes:
1. If the disease has relapsed during perioperative adjuvant chemotherapy or within 24 weeks after adjuvant chemotherapy, the adjuvant chemotherapy will be considered as the first regimen of adjuvant chemotherapy.
2. Does not include endocrine therapy for breast cancer.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Hironobu
Middle name
Last name Minami

Organization

Kobe University Graduate School

Division name

Oncology and Hematology, Internal Medicine Program, Medical Research Division

Zip code

650-0017

Address

7-5-1, Kusunokicho, Chuo-ku, Kobe City, Hyogo Prefecture

TEL

078-382-5820

Email

hminami@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Akira
Middle name
Last name Yamao

Organization

Public Health Research Foundation

Division name

Office of Comprehensive Support Project for Oncology Research (CSPOR)

Zip code

169-0051

Address

1-1-7 Nishiwaseda, Shinjuku-ku, Tokyo

TEL

03-5287-2636

Homepage URL


Email

csp-qol@csp.or.jp


Sponsor or person

Institute

Public Health Research Foundation

Institute

Department

Personal name



Funding Source

Organization

National Institute of Public Health

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kobe university hospital clinical and translational research center

Address

7-5-1, Kusunokicho, Chuo-ku, Kobe City, Hyogo Prefecture

Tel

078-382-6669

Email

kainyu@med.kobe-u.ac.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



Other administrative information

Date of disclosure of the study information

2020 Year 11 Month 13 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

Enrolling by invitation

Date of protocol fixation

2020 Year 11 Month 13 Day

Date of IRB

2021 Year 01 Month 26 Day

Anticipated trial start date

2021 Year 06 Month 18 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 11 Month 13 Day

Last modified on

2023 Year 04 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048457


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name