Development and Validation of a Personalized Digital Healthcare Model for Managing Side Effects in Breast Cancer Survivors
NCT ID: NCT06729684
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
72 participants
INTERVENTIONAL
2024-11-13
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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control (Conventional Treatment)
* breast cancer surgery with CTx/RTx/HTx
* brochure training
No interventions assigned to this group
intervention (digital health)
* breast cancer surgery with CTx/RTx/HTx
* brochure training
* add digital health (application + smartwatch)
digital health (application and smartwatch)
The application allows users to conduct self-assessments for managing symptoms and side effects related to treatment. Based on the assessment results, it provides personalized self-management strategies. Additionally, users can access features for exercise, diet, and weight management.
Interventions
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digital health (application and smartwatch)
The application allows users to conduct self-assessments for managing symptoms and side effects related to treatment. Based on the assessment results, it provides personalized self-management strategies. Additionally, users can access features for exercise, diet, and weight management.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
FEMALE
No
Sponsors
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Pusan National University Yangsan Hospital
OTHER
Samsung Medical Center
OTHER
Responsible Party
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JiHye Hwang
Professor
Locations
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Samsung Medical Center
Seoul, Republic of Korea, South Korea
Countries
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Central Contacts
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Facility Contacts
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Sun Woo Kim
Role: primary
Other Identifiers
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HA23C0423
Identifier Type: OTHER
Identifier Source: secondary_id
SMC 2023-10-048-010
Identifier Type: -
Identifier Source: org_study_id