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NCT Number: NCT06729684

Development and Validation of a Personalized Digital Healthcare Model for Managing Side Effects 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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, Republic of Korea, 06351, South Korea

Location status: Recruiting

Location contact

Sun Woo Kim

CONTACT

[email protected]

01055028826

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. PROMIS29

    Time frame: 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 outcomes

  1. EQ-5D-5L

    Time frame: 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.

  2. PRO-CTCAE

    Time frame: 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.

  3. ICF (International Classification of Functioning, Disability, and Health)

    Time frame: 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).

  4. Activity (step count)

    Time frame: 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

  5. TTM (Transtheoretical Model)

    Time frame: 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

  6. OBQ-K

    Time frame: 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.

  7. CBI-K

    Time frame: 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.

  8. body composition (inbody)

    Time frame: 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

Other outcomes

  1. SUS

    Time frame: Month 6

    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.

  2. satisfaction survey

    Time frame: Month 6

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sun Woo Kim, MS

CONTACT

[email protected]

+82-2-2008-4192

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Pusan National University Yangsan Hospital

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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