None listed
Conditions
Interventions
Others : This study will prospectively recruit and observe the intervention group, which undergoes breast reconstruction surgery and uses the clinical trial device (PinkDoc Homespital), while the cont
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Intervention Group (Prospective Recruitment) Eligibility criteria for inclusion: Female adults aged 19 years or older Undergoing breast reconstruction surgery due to breast cancer Possesses a device with specifications capable of running the clinical trial device (PinkDoc Homespital) (see 6.1.4. Raw Materials) Has received sufficient explanation of the clinical trial, understands it, voluntarily decides to participate, and agrees in writing to comply with the precautions 2. Control Group (Retrospective Medical Record Analysis) Eligibility criteria for inclusion: Female adults aged 19 years or older Underwent breast reconstruction surgery due to breast cancer between January 2023 and June 2024, and has Breast-Q scores from before surgery (within 2 months prior) and at the 12-week post-surgery (±7 days) time point* *Participants must have the following Breast-Q scores from both (1) and (2): (1) Breast-Q scores before surgery and at the 12-week post-surgery (±7 days) time point Psychosocial Well-Being, Sexual Well-Being, Physical Well-Being: Chest, Satisfaction with Breasts, Satisfaction with Abdomen**, Physical Well-Being: Abdomen**, Breast Sensation, Breast Symptoms **For patients who underwent abdominal tissue-based reconstruction (2) Breast-Q scores at 12 weeks post-surgery (±7 days) Satisfaction with Implants†, Breast Sensation: Quality of Life Impact, Adverse Effects of Radiation‡, Patient Experience: Satisfaction with Information, Satisfaction with Surgeon, Satisfaction with Medical Team, Satisfaction with Office Staff †For patients who underwent implant-based reconstruction ‡For patients who received radiation therapy
Exclusion criteria
Exclusion criteria: Participants who meet any of the following exclusion criteria will be excluded from this clinical trial: Individuals with clinically significant findings that the principal investigator deems medically inappropriate for participation in the study Patients with a history of any cancer other than breast cancer diagnosed within 2 years prior to the screening (intervention group) or before breast reconstruction surgery (control group) Individuals who have taken or are currently taking any prohibited medications for this clinical trial (antidepressants, mood stabilizers, antipsychotics) within 3 months prior to the screening (intervention group) or before breast reconstruction surgery (control group) For the intervention group, individuals who participated in another clinical trial within 1 month prior to the screening and were administered investigational drugs or devices (however, participation is allowed if the investigator determines that participation in the previous clinical trial does not affect this study) For the intervention group, individuals who experience difficulty using general-purpose devices (e.g., smartphones or tablet PCs) Individuals whom the investigator deems unsuitable for participation in the clinical trial for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in Breast-Q* | — |
Secondary
| Measure | Time frame |
|---|---|
| App satisfaction survey scores;the number of healthcare provider feedback sessions and app satisfaction scores;the number of healthcare provider feedback sessions and adherence;Breast-Q† score;Complication‡ incidence rate;Time to the first detection of complications;adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactHeeyea Choi
Seoul National University Bundang Hospital
Outcome results
None listed