breast cancer
Conditions
Interventions
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.
The control group will
Sponsors
Jichi medical university of medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Japan
Contacts
Public Contactyoshihiro sowa
Jichi medical university of medicine Department of Plastic and Reconstructive Surgery
Outcome results
None listed