Personalized digital healthcare 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
This study is testing a new digital health program to help breast cancer survivors manage side effects from their treatments using a mobile app and smartwatch.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Seoul, Republic of Korea) |
| Trial ID | NCT06729684 on ClinicalTrials.gov |
What this trial studies
This research aims to develop and validate a personalized digital healthcare model designed to help breast cancer survivors manage acute and chronic side effects resulting from various treatments such as surgery, chemotherapy, and radiation. The approach involves utilizing digital health technologies, including a mobile application and smartwatch, to provide tailored self-management strategies based on individual self-assessment results. The study will also evaluate the clinical applicability of this model to address the diverse healthcare needs of breast cancer survivors effectively.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 to 65 who have undergone surgery for Stage 1-2 breast cancer and possess a smartphone.
Not a fit: Patients who have only undergone mastectomy without additional treatments or those with severe comorbidities that hinder participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this model could significantly improve the quality of life for breast cancer survivors by providing personalized support for managing treatment-related side effects.
How similar studies have performed: While the approach of using digital health technologies for managing side effects in cancer survivors is gaining traction, this specific model is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul, Republic of Korea
- Samsung Medical Center — Seoul, Republic of Korea, South Korea (Recruiting)
Study contacts
- Study coordinator: Sun Woo Kim, MS
- Email: k.sunwoo0418@gmail.com
- Phone: +82-2-2008-4192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.