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

NCT06729684 | Recruiting

• 2 other identifiers: SMC 2023-10-048-010HA23C0423
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Survivorship; Breast Cancer; Digital Health

Outcome Measures

Primary Outcomes (1)

• PROMIS29

  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.

  Baseline, Month 1, Month 3, Month 6

Secondary Outcomes (8)

• EQ-5D-5L

  Baseline, Month 1, Month 3, Month 6

• PRO-CTCAE

  Month 1, Month 3, Month 6

• ICF (International Classification of Functioning, Disability, and Health)

  Baseline, Month 1, Month 3, Month 6

• Activity (step count)

  Baseline, Month 1, Month 3, Month 6

• TTM (Transtheoretical Model)

  Baseline, Month 3, Month 6

Other Outcomes (2)

• SUS

  Month 6

• satisfaction survey

  Month 6

Study Arms (2)

control (Conventional Treatment)

NO INTERVENTION

* breast cancer surgery with CTx/RTx/HTx * brochure training

intervention (digital health)

EXPERIMENTAL

* breast cancer surgery with CTx/RTx/HTx * brochure training * add digital health (application + smartwatch)

Device: digital health (application and smartwatch)

Interventions

digital health (application and smartwatch) DEVICE

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.

intervention (digital health)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Pusan National University Yangsan Hospital: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, Republic of Korea, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Sun Woo Kim, MS

CONTACT

+82-2-2008-4192; k.sunwoo0418@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 11, 2024
• Study Start: November 13, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)