Breast Cancer SurvivorshipNCT06729684
Development and Validation of a Personalized Digital Healthcare Model for Managing Side Effects in Breast Cancer Survivors
A study testing digital health (application and smartwatch) in people with Breast Cancer Survivorship and Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer Survivorship, Breast Cancer, Digital Health
- What is being tested?
- digital health (application and smartwatch)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Nov 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Republic of Korea, 06351
Sun Woo Kim, 01055028826, k.sunwoo0418@gmail.com
About this study
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
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
- Being tested
- digital health (application and smartwatch)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: digital health (application and smartwatch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Month 1, Month 3, Month 6
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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:
- 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).
Measured: 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
Measured: Baseline, Month 1, Month 3, Month 6
TTM (Transtheoretical Model)
Full Title: The Transtheoretical Model staging Objective: behavior change stage
Scoring System:
- 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
Measured: 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.
Measured: 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:
- 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.
Measured: 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
Measured: Baseline, Month 1, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start13 Nov 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorshipStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pusan National University Yangsan Hospital
- Responsible party
- Principal investigator, JiHye Hwang, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729684
- Sponsor's protocol ID
- SMC 2023-10-048-010
- Other IDs
- HA23C0423
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06729684
- Acronym / sponsor ID
- SMC 2023-10-048-010
- Conditions
- Breast Cancer Survivorship, Breast Cancer, Digital Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Pusan National University Yangsan Hospital
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control (Conventional Treatment) | No intervention | –* breast cancer surgery with CTx/RTx/HTx * brochure training |
| intervention (digital health) | Experimental | Device: digital health (application and smartwatch)* breast cancer surgery with CTx/RTx/HTx * brochure training * add digital health (application + smartwatch) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | intervention (digital health) |
Primary outcome
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital health (application and smartwatch) in people with Breast Cancer Survivorship and Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sun Woo Kim, MS (+82-2-2008-4192, k.sunwoo0418@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS29 (time frame: Baseline, Month 1, Month 3, Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.