Clinical trial NCT06729684: Development and Validation of a Personalized Digital Healthcare Model for Managing Side Effects in Breast Cancer Survivors
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Survivorship
Breast Cancer
Digital Health
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Pusan National University Yangsan Hospital
First posted: 2024-12-11
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: PROMIS29
timeFrame: Baseline, Month 1, Month 3, Month 6
Secondary outcomes:
measure: EQ-5D-5L
timeFrame: Baseline, Month 1, Month 3, Month 6
measure: PRO-CTCAE
timeFrame: Month 1, Month 3, Month 6
measure: ICF (International Classification of Functioning, Disability, and Health)
timeFrame: Baseline, Month 1, Month 3, Month 6
measure: Activity (step count)
timeFrame: Baseline, Month 1, Month 3, Month 6
measure: TTM (Transtheoretical Model)
timeFrame: Baseline, Month 3, Month 6
measure: OBQ-K
timeFrame: Baseline, Month 3, Month 6
measure: CBI-K
timeFrame: Baseline, Month 3, Month 6
measure: body composition (inbody)
timeFrame: Baseline, Month 1, Month 3, Month 6
Other outcomes:
measure: SUS
timeFrame: Month 6
measure: satisfaction survey
timeFrame: Month 6
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Republic of Korea
Study officials:
References: