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Recruiting NCT06729684

Development and Validation of a Personalized Digital Healthcare Model for Managing Side Effects in Breast Cancer Survivors

No phase Interventional Breast Cancer Survivorship Breast Cancer Digital Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: digital health (application and smartwatch).
Who it may be relevant to
Registry conditions: Breast Cancer Survivorship, Breast Cancer, Digital Health. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Device 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.

Primary outcome measures

  • PROMIS29 [Time frame: Baseline, Month 1, Month 3, Month 6]
Secondary outcome measures (8)
  • EQ-5D-5L [Time frame: Baseline, Month 1, Month 3, Month 6]
  • PRO-CTCAE [Time frame: Month 1, Month 3, Month 6]
  • ICF (International Classification of Functioning, Disability, and Health) [Time frame: Baseline, Month 1, Month 3, Month 6]
  • Activity (step count) [Time frame: Baseline, Month 1, Month 3, Month 6]
  • TTM (Transtheoretical Model) [Time frame: Baseline, Month 3, Month 6]
  • OBQ-K [Time frame: Baseline, Month 3, Month 6]
  • CBI-K [Time frame: Baseline, Month 3, Month 6]
  • body composition (inbody) [Time frame: Baseline, Month 1, Month 3, Month 6]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

South Korea · 1 center
  • Samsung Medical Center — Seoul

Identifiers

NCT: NCT06729684 · SMC 2023-10-048-010 · HA23C0423

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗