UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052161 |
|---|---|
| Receipt number | R000057528 |
| Scientific Title | Shared Decision-Making Using a Decision Aid for Patients with Breast Cancer Considering Breast Reconstruction: Study Protocol for a Cluster-Randomized Controlled Trial in Japan |
| Date of disclosure of the study information | 2023/09/09 |
| Last modified on | 2024/10/03 09:49:17 |
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Basic information
Public title
Effectiveness of Shared Decision Making with Decision Aids for Breast Cancer Patients Considering Breast Reconstruction: A Cluster Randomized Controlled Trial
Acronym
Effectiveness of Shared Decision Making with Decision Aids for Breast Cancer Patients Considering Breast Reconstruction: A Cluster Randomized Controlled Trial
Scientific Title
Shared Decision-Making Using a Decision Aid for Patients with Breast Cancer Considering Breast Reconstruction: Study Protocol for a Cluster-Randomized Controlled Trial in Japan
Scientific Title:Acronym
SDMDA
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate the clinical effectiveness of SDM and Decision Aids (DA) utilisation in breast reconstruction from the perspective of decision-making conflict and postoperative quality of life, from an overview of Shared Decision Making (SDM) for breast cancer patients considering breast reconstruction. The purpose of this study is to examine the clinical effectiveness of the Decision Aids (DA) guide in breast reconstruction by investigating the clinical effectiveness of the use of SDM and Decision Aids (DA) in terms of decision-making conflict and post-operative quality of life. The aim is also to clarify the usefulness of decision guides in supporting decision-making and improving post-operative quality of life in the increasingly diverse selection of breast reconstruction procedures for breast cancer patients considering breast reconstruction, and to provide a resource for considering guidelines for implementing decision-making in the correct process.We plan to perform Cluster-Randomized Controlled Trial in Japan. Types of trial include: parallel testing of two groups with equal allocation ratios, superiority testing.The purpose of this multicenter collaborative study is to evaluate the clinical effectiveness of implementation of SDM using a DA in breast reconstruction for patients with breast cancer, from the perspectives of decision conflict, effectiveness of SDM, and postoperative quality of life (QOL) and satisfaction. In summary, the study also aims to show the usefulness of a DA in supporting decision-making and improving postoperative QOL for patients with breast cancer based on consideration of breast reconstruction options, and to provide a resource for establishing guidelines to ensure decisions are made through the correct processes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome measure of the study is the Decision Conflict Scale (DCS), for which summary statistics will be calculated for each surgical method at the following time points: before the surgical decision (Time 1), immediately after the surgical decision (Time 2), 1 month post-surgery (Time 3), and 1 year post-surgery (Time 4). Data will be analyzed for comparisons between groups and for changes over time. The DCS was developed in 1995 to measure uncertainty in choosing healthcare options, modifiable factors contributing to this uncertainty, and the quality of the decision-making process . The DCS has 16 items assessing 5 dimensions of decision-making: feeling uncertain (3 items), feeling uninformed (3 items), feeling unclear about personal values (3 items), feeling unsupported (3 items), and ineffective decision-making (4 items) . This scale is available in Japanese and is useful for evaluating the impact of decision support interventions (DESI) and for determining how to tailor DESI to meet the specific needs of patients.
Key secondary outcomes
The secondary outcome measures include the SDM-Q-9 score, which will be used to assess the effectiveness of SDM immediately after the surgical decision, and the BREAST-Q to evaluate satisfaction and health-related quality of life (HRQOL) after breast reconstruction at one month (Time 3) and one year (Time 4) postoperatively. These scores will also be compared between groups.SDM-Q-9: The SDM-Q-9 is a validated 9-item questionnaire to assess the level of SDM perceived by patients. Each item describes a separate step in the SDM process and is rated on a 6-point Likert scale from 0to 5. Higher scores are indicative of more SDM. Summed scores per patient will be calculated (range:0 to 45) and multiplied by 100/45 to obtain a percentage of the maximum score.
BREAST-Q: The BREAST-Q is a self-administered assessment tool composed of 15 subscales and 121 items designed to measure the impact of breast surgery on patient satisfaction and HRQOL. Each subscale is scored from 0 to 100, with higher scores indicating greater satisfaction and quality of life. In this study, the following 4 subscales will be used: satisfaction with breasts, psychosocial well-being, physical well-being of the chest and upper body, and sexual well-being. An official Japanese version of the BREAST-Q has been developed and validation of the reconstruction module has been completed (Cronbach's a> 0.7, inter-rater reliability (icc) > 0.8).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In addition to the general knowledge pamphlet, the DA "Guide to Deciding on Your Own Breast Reconstruction" will be used to practice SDM; facility directors who have completed a prepared educational program prior to practicing SDM will participate in the study. The decision to reconstruct the breast is then made.
Interventions/Control_2
The control group will be offered only the knowledge brochures provided at the facility to make breast reconstruction decisions.
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
The potential subjects are patients scheduled for breast cancer surgery at an outpatient plastic surgery clinic at Kyoto University Hospital and participating centers. A determination of whether each patient meets the trial criteria will be made at their clinic visit to discuss breast reconstruction. To be eligible, patients must meet all of the following inclusion criteria:(i)pathological diagnosis of breast cancer between the date of approval for implementation by the head of the research center and March 31, 2026, and visiting an outpatient plastic surgery clinic to be considered for breast reconstruction surgery; (ii) age more than 20 years old at the time of diagnosis; (iii) female; and (iv) breast cancer stage 0-III.
Key exclusion criteria
Patients meeting any of the following criteria will be excluded: (i) secondary breast reconstruction; (ii) diagnosed with recurrent or distant metastasis of breast cancer; (iii) undergoing expander insertion; (iv) difficulty answering the questionnaire in Japanese; (v) participants who discontinue or deviate from intervention protocols, and (vi) serious complications such as mastectomy flap necrosis in breast surgery or breast reconstruction, or implant infection requiring prolonged hospitalization and revision surgery.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | yoshihiro |
| Middle name | |
| Last name | sowa |
Organization
Jichi medical university
Division name
Department of Plastic Surgery
Zip code
329-0498
Address
3311-1, Yakushiji, Shimotsuke, 329-0498 Tochigi, Japan
TEL
09042835630
ysowawan@gmail.com
Public contact
Name of contact person
| 1st name | yoshihiro |
| Middle name | |
| Last name | sowa |
Organization
Jichi medical university of medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
6028566
Address
3311-1, Yakushiji, Shimotsuke, 329-0498 Tochigi, Japan
TEL
0285587068
Homepage URL
https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000052161
ysowawan@gmail.com
Sponsor or person
Institute
Jichi medical university of medicine
Institute
Department
Personal name
Yoshihiro Sowa
Funding Source
Organization
the Japan Oncoplastic Breast Surgery Society.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Ethics Committee
Address
54 Shogoin Kawahara-cho, Sakyou-ku, Kyoto 606-8507
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
C1608
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Department of Plastic Surgery, Jichi Medical University, Tochigi, Japan
Department of Plastic and Reconstructive Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan
Department of Plastic and Reconstructive Surgery, Tokyo Medical University, Tokyo, Japan
Department of Plastic Surgery, Okayama University Hospital, Okayama, Japan
Department of Plastic and Reconstructive Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan
Department of Breast Surgical Oncology, St. Luke's International Hospital, Tokyo, Japan
Department of Breast Surgery, Kyorin University School of Medicine, Tokyo, Japan
Department of Plastic and Reconstructive Surgery, Osaka Medical and Pharmaceutical University, Osaka, Japan
Department of Plastic and Reconstructive Surgery, Kansai Medical University, Osaka, JapanDepartment of Plastic and Reconstructive Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan
Department of Plastic, Reconstructive, and Aesthetic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan
Department of Reconstructive Plastic Surgery, Nara City Hospital, Nara, Japan
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 09 | 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 | 09 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 09 | Day |
Last modified on
| 2024 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057528
