UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049536 |
|---|---|
| Receipt number | R000056404 |
| Scientific Title | Questionnaire exploring patients' enthusiasm for ultrahypofractionated postoperative radiation therapy following breast conservation surgery |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2025/01/06 12:17:13 |
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Basic information
Public title
Questionnaire exploring patients' enthusiasm for ultrahypofractionated postoperative radiation therapy following breast conservation surgery
Acronym
QUATTRO study
Scientific Title
Questionnaire exploring patients' enthusiasm for ultrahypofractionated postoperative radiation therapy following breast conservation surgery
Scientific Title:Acronym
QUATTRO study
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore patient's needs for ultrahypofractionated radiotherapy following breast conservation surgery in patients with breast cancer.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Patient's needs for ultrahypofractionated radiotherapy following breast conservation surgery.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Breast cancer patients undergoing postoperative radiation therapy with mild hypofractionation or standard fractionation regimen following breast conservation surgery
Key exclusion criteria
Patients undergoing accelerated partial breast radiation therapy, ultrahypofractionated regimen, or regional nodal irradiation
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | |
| Last name | Uezono |
Organization
Hyogo Cancer Center
Division name
Department of Radiation Oncology
Zip code
673-8558
Address
13-70 Kitaoji-Cho, Akashi
TEL
0789291151
haru770911@yahoo.co.jp
Public contact
Name of contact person
| 1st name | haruka |
| Middle name | |
| Last name | uezono |
Organization
Hyogo Cancer Center
Division name
Department of Radiation Oncology
Zip code
673-8558
Address
13-70 Kitaoji-Cho, Akashi
TEL
0789291151
Homepage URL
haru770911@yahoo.co.jp
Sponsor or person
Institute
Hyogo Cancer Center, Department of Radiation Oncology
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Research Development Fund
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
hyogo cancer center
Address
13-70 Kitaoji-Cho, Akashi
Tel
0789291151
haru770911@yahoo.co.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
| 2022 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
247
Results
Between November 2022 and June 2023, 247 questionnaires were collected. The number of patients divided by age group were <50:50's:60's:>70 = 59 (24%):76 (30%):63 (26%):49 (20%). Sixty-nine percent rated six or more out of ten (45% rated 10/10) regarding their enthusiasm for UH regimen. The highest priority for majority of patients (89%) was treatment efficacy while the lowest priority was breast cosmesis rated by 53% of the cohort.
Results date posted
| 2025 | Year | 01 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The number of patients divided by age group were <50:50's:60's:>70 = 59 (24%):76 (30%):63 (26%):49 (20%).
Participant flow
The questionnaire was filled within five days before or after completion of RT, then typically reviewed by the research staff to minimize unintentional error before sending the sheet to the research administration office. Patients were welcomed to send the questionnaire directly to the research administration office if they wished the sheets not to be reviewed by local research staffs.
Adverse events
AEs were not assessed in the study.
Outcome measures
1) age, 2) date of survey, 3) travel time/mode of transportation for a treatment visit, 4) number of household, number of those for need support or care at home, 5) employment status, 6) discrepancies between patient's experience during RT and prior expectation in terms of physical/socioeconomical aspects, 7) magnitude of RT impact on daily living using an 11-point (0-10) scale, 8) any RT impact on family or work environment, 9) enthusiasm for UHF regimen using an 11-point scale, 10) reluctance of long term cosmetic deterioration of the treated breast using an 11-point scale, 11) enthusiasm for shortening RT period with UHF regimen vs reluctance for developing breast induration using an 11-point scale, 12) prioritization of the following treatment-related effects: treatment efficacy; acute AEs; late AEs; physical/emotional burden during treatment; financial burden of the treatment; and long-term breast cosmesis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 09 | Month | 30 | Day |
Other
Other related information
Data will be collected regarding the patients' role within the family and the society. We will obtain patients' sense of value regarding the treatment period and the risk of long-term toxicity from ultrahypofractionated radiotherapy.
Management information
Registered date
| 2022 | Year | 11 | Month | 16 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056404
