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

Not Applicable

Recruiting

• Conditions: Breast Cancer Survivorship; Breast Cancer; Digital Health

• Registration Number: NCT06729684
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-13
• Status Verified: 2024-12
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PROMIS29	Baseline, Month 1, Month 3, Month 6	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.

Secondary Outcome Measures

Name	Time	Method
EQ-5D-5L	Baseline, Month 1, Month 3, Month 6	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.
PRO-CTCAE	Month 1, Month 3, Month 6	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.
ICF (International Classification of Functioning, Disability, and Health)	Baseline, Month 1, Month 3, Month 6	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).
Activity (step count)	Baseline, Month 1, Month 3, Month 6	Objective: Number of steps taken in the past month Scoring System: Number of steps measured by mobile phone
TTM (Transtheoretical Model)	Baseline, Month 3, Month 6	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
OBQ-K	Baseline, Month 3, Month 6	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.
CBI-K	Baseline, Month 3, Month 6	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.
body composition (inbody)	Baseline, Month 1, Month 3, Month 6	Weight: kg BMI(Body mass index): kg/m\^2 SMI(Appendicular Skeletal Muscle Mass Index): kg/m\^2

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Republic of Korea, Korea, Republic of