UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056741 |
|---|---|
| Receipt number | R000064615 |
| Scientific Title | A Multicenter Randomized Controlled Trial to Preliminarily Evaluate the Efficacy of Online Peer Support for Patients with Breast Cancer. |
| Date of disclosure of the study information | 2025/01/17 |
| Last modified on | 2025/01/17 13:50:33 |
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Basic information
Public title
A Multicenter Randomized Controlled Trial to Preliminarily Evaluate the Efficacy of Online Peer Support for Patients with Breast Cancer.
Acronym
HOPE-BC: Helping each Other by Peer Empowerment for Breast Cancer
Scientific Title
A Multicenter Randomized Controlled Trial to Preliminarily Evaluate the Efficacy of Online Peer Support for Patients with Breast Cancer.
Scientific Title:Acronym
HOPE-BC: Helping each Other by Peer Empowerment for Breast Cancer
Region
| Japan |
Condition
Condition
Early-stage breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the usefulness of online peer support for early-stage breast cancer patients. In order to determine the compatibility of appropriate peer support, also examine the level of satisfaction and other factors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
UCLA Loneliness Scale after 1 week of peer support
Key secondary outcomes
1) Satisfaction with peer support (as rated by Numerical Rating Scale [NRS])
2) Usefulness and evaluation of peer support
3) Generalized Anxiety Disorder -7 (GAD -7) Japanese version
4) Patient Health Questionnaire -9 (PHQ -9) Japanese version
5) Concerns about Recurrence scale Japanese version: CARS -J (CARS -J)
6) Short -form Supportive Care Needs Survey (SCNS -SF34) Japanese version (SCNS -SF34 -J)
7) Modified Depression and Anxiety Mood Scale (mDAMS) Japanese version
8) European Organization for Research and Treatment of Cancer (EORTC) QLQ -C30 Japanese version
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
Peer support Group
Interventions/Control_2
Waiting Group
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
Female
Key inclusion criteria
1) Patients aged 18 and over at the time of informed consent
2) Femele
3) Early -stage breast cancer patients
4) Patients within three years after early -stage breast cancer treatment
/If only surgery is planned, patients can be enrolled after surgery.
/If postoperative adjuvant therapy is planned, patients can be enrolled after completion or discontinuation of the planned adjuvant therapy. However, patients can be enrolled before completion or discontinuation of administering hormone therapy as a monotherapy.
5) Patients who are able to use the Decentralized Clinical Trial (DCT) system
E.g., patients who use email and the Internet on a daily basis.
6) Patients who can provide consent via eConsent.
Key exclusion criteria
1)Patients with active concurrent cancer.
* Lesions equivalent to carcinoma in situ or mucosal carcinoma that can be cured with local therapy are not considered active concurrent cancers.
2) Patients deemed ineligible by the investigator or others, regardless of the reason.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshinari |
| Middle name | |
| Last name | Yamashita |
Organization
Kanagawa Cancer Center
Division name
Department of breast surgery
Zip code
241-8515
Address
2 -3 -2, Nakao, Asahi -ku, Yokohama -city, Kanagawa
TEL
045-520-2222
tyamashita@kcch.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Nakajima |
Organization
Daiichi Sankyo Co., Ltd
Division name
Global DX HaaS Planning Department
Zip code
103-8426
Address
3 -5 -1, Nihonbashi Honcho, Chuo -ku, Tokyo
TEL
03-6225-1111
Homepage URL
Izutani.tadahiro.sa@daiichisankyo.co.jp
Sponsor or person
Institute
Daiichi Sankyo Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nonprofit Organization MINS IRB
Address
5 -20 -9 -401, Mita, Minato -ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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
神奈川県立がんセンター（神奈川県）、北海道大学病院（北海道）、八戸市立市民病院（青森県）、秋田大学医学部附属病院（秋田県）、東京慈恵会医科大学附属病院（東京都）、名古屋市立大学病院（愛知県）、大谷しょういちろう乳腺クリニック（広島県）、熊本大学病院（熊本県）、那覇西クリニック（沖縄県）、キャンサ -ネットジャパン（東京都）
Kanagawa Cancer Center(Kanagawa), Hokkaido University Hospital(Hokkaido), Hachinohe City Hospital (Aomori), Akita University Hospital (Akita), Tokyo Jikei University Hospital (Tokyo), Nagoya City University Hospital (Aichi), Otani Shoichiro Breast Clinic (Hiroshima), Kumamoto University Hospital (Kumamoto), Naha West Clinic (Okinawa), Cancer Net Japan (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 17 | 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
| 2024 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 08 | 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
| 2025 | Year | 01 | Month | 17 | Day |
Last modified on
| 2025 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064615
