UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044502
Receipt No. R000050444
Scientific Title Effects of PHR / PRO (Personal Health Record/Patient Reported Outcome) on QOL in breast cancer patients receiving adjuvant hormonal therapy: a randomized controlled trial.
Date of disclosure of the study information 2021/06/11
Last modified on 2021/06/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of PHR / PRO (Personal Health Record/Patient Reported Outcome) on QOL in breast cancer patients receiving adjuvant hormonal therapy: a randomized controlled trial.
Acronym Randomized controlled trial for the effects of PHR / PRO in breast cancer patients receiving adjuvant hormonal therapy.
Scientific Title Effects of PHR / PRO (Personal Health Record/Patient Reported Outcome) on QOL in breast cancer patients receiving adjuvant hormonal therapy: a randomized controlled trial.
Scientific Title:Acronym Randomized controlled trial for the effects of PHR / PRO in breast cancer patients receiving adjuvant hormonal therapy.
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The present study conducts a randomized controlled trial to examine the effects of communication support system, PHR / PRO, on QOL in breast cancer patients who receive adjuvant hormonal therapy.
Basic objectives2 Others
Basic objectives -Others FACT-B (Functional Assessment of Cancer Therapy-Breast)
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes QOL evaluated by FACT-B (Functional Assessment of Cancer Therapy-Breast) at before starting adjuvant hormonal therapy and 3 months after the start of adjuvant hormonal therapy.
Key secondary outcomes Adherence

Analyses of difference between PRO-CTCAE evaluated by patients and CTCAE v5.0-JCOG evaluated by medical stuffs (1headache,2arthralgia,3insomnia,4anxiety symptoms,5hot flushes).

Disease-free survival rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 Interventions: Patients evaluate side effects by PRO and adherence, and record them to PHR during adjuvant hormonal therapy.
Interventions/Control_2 Control: Patients not use of the PRO/PHR.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Patients who gave written informed consent.

Patients who receive first line adjuvant hormonal therapy (anastrozole, retrozole, or exemestane) at Breast Center in Showa University.

Patients who consult a clinic related to Showa University hospital during adjuvant hormonal therapy.

Patients who can cooperate with the questionnaire.
Key exclusion criteria Patients who had received hormonal therapy in the past.

Patients with recurrent breast cancer.

Patients who cannot evaluate symptoms due to mental illness or cognitive dysfunction.

Patients who cannot operate smartphones or tablets.

Patients who cannot use of email.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Seigo
Middle name
Last name Nakamura
Organization Showa University
Division name Department of Breast Surgical Oncology
Zip code 142-8666
Address 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL 03-3784-8511
Email breastc@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Hiromi
Middle name
Last name Okuyama
Organization Showa University
Division name Department of Advanced Cancer Translational Research Institute
Zip code 142-8555
Address 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL 03-3784-8511
Homepage URL
Email hiromiok@med.showa-u.ac.jp

Sponsor
Institute Showa University
Institute
Department

Funding Source
Organization Showa University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethics Committee of Showa University graduate School of Medicine
Address 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
Tel 03-3784-8129
Email m-rinri@ofc.showa-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
2021 Year 06 Month 11 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 Preinitiation
Date of protocol fixation
2021 Year 04 Month 22 Day
Date of IRB
2021 Year 05 Month 20 Day
Anticipated trial start date
2021 Year 06 Month 15 Day
Last follow-up date
2027 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 06 Month 11 Day
Last modified on
2021 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050444

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.