Development and Validation of a Personalized Digital Healthcare Model 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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Digital Health; Breast Cancer Survivorship
• Intervention / Treatment: Device: digital health (application and smartwatch)

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sun Woo Kim, MS; Phone Number: +82-2-2008-4192; Email: k.sunwoo0418@gmail.com

Study Locations

• Korea, Republic of
  • Republic of Korea
    • Seoul, Republic of Korea, Korea, Republic of, 06351
      • Recruiting
      • Samsung Medical Center
      • Contact: Sun Woo Kim; Phone Number: 01055028826; Email: k.sunwoo0418@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control (Conventional Treatment); breast cancer surgery with CTx/RTx/HTx; brochure training
Experimental: intervention (digital health); breast cancer surgery with CTx/RTx/HTx; brochure training; add digital health (application + smartwatch)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D-5L	Full Title: EuroQol 5-Dimension 5-level Objective: quality of life Scoring System: Each item is evaluated on a 5-point scale and weighted according to the country. EQ VAS evaluates data on a scale of 0-100, with a higher score indicating better health.	Baseline, Month 1, Month 3, Month 6
PRO-CTCAE	Full Title: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Objective: Clinical symptoms and adverse effects reported by patients Scoring System: Evaluate the frequency, severity, interference with daily activities, amount, and presence/absence of side effects over the past 7 days.	Month 1, Month 3, Month 6
ICF (International Classification of Functioning, Disability, and Health)	Full Title: International Classification of Functioning, Disability and Health Objective: function, activity and participant, environment Scoring System: A. Assess the 8 items of body functions, 8 items of activities and participation, and 8 items of environmental factors of the breast cancer ICF core set brief B. Body functions are assessed as 0 (no problems) - 4 (extreme problems), 9 (not applicable). Activities and participation are assessed as 0 (no difficulties) - 4 (extreme difficulties), 9 (not applicable). Environment is assessed as 0 (no barriers) - 4 (extreme barriers), +0 (no facilitating factors) - +4 (complete facilitating factors), 9 (not applicable).	Baseline, Month 1, Month 3, Month 6
Activity (step count)	Objective: Number of steps taken in the past month Scoring System: Number of steps measured by mobile phone	Baseline, Month 1, Month 3, Month 6
TTM (Transtheoretical Model)	Full Title: The Transtheoretical Model staging Objective: behavior change stage Scoring System: A. Assess health behavior change on a 5-step scale B. (1) Before consideration: No intention to change problem behavior or adopt healthy behavior within the next 6 months, (2) Consideration: No specific plan but plan to take action within the next 6 months, (3) Preparation: Plan to take action within the next 30 days, (4) Action: In progress (less than 6 months), (5) Maintenance: In progress (more than 6 months) C. Check whether the change in the stage has occurred in a positive direction	Baseline, Month 3, Month 6
OBQ-K	Full Title: Occupaitonal Balance Questionnaire Objective: occupational balance Scoring System: 13 items, 0-5 point scale. The score range is 0-65 points, and a higher score indicates greater work balance.	Baseline, Month 3, Month 6
CBI-K	Full Title: Cancer Behavior Inventory version 3.0 - Korea Objective: Measuring self-efficacy for coping behaviors that can be taken during cancer treatment Scoring System: A. Consists of 7 subscales (27 items): Maintaining activity and independence (4 items), Seeking and understanding medical information (4 items), Managing stress and pain (4 items), Managing side effects (4 items), Accepting cancer/maintaining a positive attitude (4 items), Finding social support (3 items), Using spiritual coping methods (4 items) B. Rating on a 7-point scale. A higher score indicates a higher self-efficacy for overcoming cancer.	Baseline, Month 3, Month 6
body composition (inbody)	Weight: kg BMI(Body mass index): kg/m^2 SMI(Appendicular Skeletal Muscle Mass Index): kg/m^2	Baseline, Month 1, Month 3, Month 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SUS	Full Title: System Usability Scale Objective: System Usability Scoring System: A. 10 questions, 5-point scale B. Total = ((sum of odd questions - 5) + (25 - sum of even questions)) * 2.5 C. Score range is 0-100, and the benchmark is known to be 68 points.	Month 6
satisfaction survey	Objective: Check app satisfaction and suggestions/issues Scoring system: A. Self-administered questionnaire b. Use a semi-structured survey to assess app satisfaction and gather suggestions/issues.	Month 6

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SMC 2023-10-048-010; HA23C0423 (Other Identifier: National Cancer Center (NCC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No