Clinical trial · Interventional
Development and Validation of a Personalized Digital Healthcare Model for Managing Side Effects in Breast Cancer Survivors
Development and Validation of Personalized Digital Healthcare Technology and Service Model for the Management and Recovery of Side Effects of Treatment in Breast Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The ultimate goal of this research and development is to develop personalized digital healthcare technologies and self-management strategies based on self-assessment results and evidence, for breast cancer survivors who require management and recovery from acute and chronic side effects related to various treatments (surgery, chemotherapy, radiation, hormone therapy, etc.). Additionally, the aim is to verify the clinical applicability and establish a service model to address the diverse unmet healthcare needs of breast cancer survivors.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Survivorship | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Digital Health | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| digital health (application and smartwatch) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- control (Conventional Treatment)
- description
- * breast cancer surgery with CTx/RTx/HTx * brochure training
- type
- EXPERIMENTAL
- label
- intervention (digital health)
- description
- * breast cancer surgery with CTx/RTx/HTx * brochure training * add digital health (application + smartwatch)
- interventionNames
- Device: digital health (application and smartwatch)
Primary outcomes (1)
- measure
- PROMIS29
- timeFrame
- Baseline, Month 1, Month 3, Month 6
- description
- Full Title: Patient-Reported Outcomes Measurement Information System Objective: health related quality of life Scoring System: Each item is rated on a scale of 1 to 5. Lower scores indicate better health for pain, depression, anxiety, and fatigue, while higher scores indicate better health for physical function, social roles, and activities, and sleep disorders.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Individuals who have undergone surgery for Stage 1-2 breast cancer * Individuals who have had a unilateral mastectomy * Aged 18 years or older and under 65 years * Possessing a smartphone with either an Android or iOS operating system * Individuals who voluntarily decide to participate after receiving detailed information about the study and provide written consent Exclusion Criteria: * Individuals who have undergone mastectomy only and are not receiving chemotherapy, radiation, or hormone therapy * Individuals with severe comorbidities (such as underlying diseases, neuromuscular disorders, cognitive or mental impairments, visual disabilities, etc.) that make it difficult to use the application or participate in the exercise intervention Discontinuation Criteria * Individuals who undergo delayed breast reconstruction surgery during the study period * Individuals who develop severe complications or experience cancer metastasis or recurrence in other organs during the study period, leading to a change in treatment * Occurrence of a major illness unrelated to study participation * Failure to comply with the instructions of the study physician * Situations where the participant voluntarily withdraws from the study or becomes unable to continue participating
References
Publications (0)
Data not yet available