Breast CancerMMHTRNCT04781712
Feasibility of a Modular mHealth for Tailored Rehabilitation of Breast Cancer
A study testing Modular mHealth for Tailored Rehabilitation in people with Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study investigated the feasibility of the novel modular mobile health (mHealth) for personalized rehabilitation and explored the participants' satisfaction and app data during treatment of breast cancer. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Modular mHealth for Tailored Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Apr 2019to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Unilateral breast cancer at TNM stage 0 ~ III
- Patients who will undergo the treatment (chemotherapy, radiation therapy, and hormone therapy) after surgery
- Patients who had a mobile phone (Android or iOS)
Who cannot join
- Patients who have metastases or recurrence to other organs were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of a Modular mHealth for Tailored Rehabilitation During the Treatment of Breast Cancer
This study investigated the feasibility of the novel modular mobile health (mHealth) for personalized rehabilitation and explored the participants' satisfaction and app data during treatment of breast cancer.
Read the detailed description
This is prospective, feasible, parallel study in post-operative patients with breast cancer and during treatment. Disability of Arm, Shoulder, Hands (DASH), Physical activity data (IPAQ-SF), Physical measurement such as hand grip strength, body mass index (BMI), muscle mass, and differences in arm circumference, PRO-CTCAE, Distress Thermometer, needs and satisfaction in app, personal health record of app (exercise, daily step count, etc.) Measure will be evaluated on 1-month, 2-month, 4-month, 6-month, 9-month, and 12-month after POD.
- Conditions
- Breast Cancer
- Being tested
- Modular mHealth for Tailored Rehabilitation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modular mHealth for Tailored RehabilitationBehavioural
Also called mHealth
an individually tailored self-management through the mHealth app with a smart band worn on the wrist
| Study group | Role | What they receive |
|---|---|---|
| Self-management using mHealth | Experimental | Self-management (physical activity, sleep, exercise, education, etc.) using mHealth Receives: Behavioral: Modular mHealth for Tailored Rehabilitation |
| Exercise using brochure | No intervention | Only exercise using brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
satisfaction score in app contents
satisfaction score in app contents, Likert scale (5-point, higher scores mean a better)
Measured: 1 to 12month
Needs score in app contents
Needs score in app contents, Likert scale (5-point, higher scores mean a better)
Measured: 1 to 12month
DASH (Disabilities of Arm, Shoulder, Hands)
Change from Baseline DASH score at 12 months, higher scores mean a worse (0-100)
Measured: 1 month, 2month, 4month, 6month, 9month, 12month
Secondary outcomes (11)
Physical measurement (handgrip strength)
Handgrip strength (kg)
Measured: 1 to 12month
Physical measurement (of body composition, BMI)
Body mass index
Measured: 1 to 12month
Physical measurement (of body composition, muscle mass)
muscle mass
Measured: 1 to 12month
Physical measurement (upper extremity volume)
differences in arm circumference
Measured: 1 to 12month
Physical activity (IPAQ-SF Questionnaire)
Total METs within recent 7 days (vigorous, moderate, walking, sitting), higher values mean a better
Measured: 1 to 12month
PRO-CTCAE (patients reported outcomes)
Symptoms during treatment
Measured: 1 to 12month
Distress thermometer (distress level)
Distress level during treatment, higher scores mean a worse (0-10)
Measured: 1 to 12month
App use data (personal health record)_Exercise compliance rate
Exercise time, higher values mean a better
Measured: 1 to 12month
App use data (personal health record)_Physical activity change
daily step count (number), higher values mean a better physical activity
Measured: 1 to 12month
App use data (personal health record)_interest of contents
contents view (number), higher values mean a better compliance rate
Measured: 1 to 12month
App use data (personal health record)_sleep
sleep compliance rate (%), higher values mean a better compliance rate
Measured: 1 to 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start22 Apr 2019
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JiHye Hwang, Samsung Medical Center
- Investigators
- JIHYE HWANG, Professor, Study chair, Physical & Rehabilitation Medicine Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781712
- Sponsor's protocol ID
- SMC-2018-10-062
- Acronym
- MMHTR
- Status last verified
- Oct 2022
- First submitted
- 22 Feb 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Modular mHealth for Tailored Rehabilitation During the Treatment of Breast Cancer
- ClinicalTrials.gov ID
- NCT04781712
- Acronym / sponsor ID
- MMHTR / SMC-2018-10-062
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 4 Mar 2021 (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.
This study investigated the feasibility of the novel modular mobile health (mHealth) for personalized rehabilitation and explored the participants' satisfaction and app data during treatment of breast cancer.
Detailed description
This is prospective, feasible, parallel study in post-operative patients with breast cancer and during treatment. Disability of Arm, Shoulder, Hands (DASH), Physical activity data (IPAQ-SF), Physical measurement such as hand grip strength, body mass index (BMI), muscle mass, and differences in arm circumference, PRO-CTCAE, Distress Thermometer, needs and satisfaction in app, personal health record of app (exercise, daily step count, etc.) Measure will be evaluated on 1-month, 2-month, 4-month, 6-month, 9-month, and 12-month after POD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-management using mHealth | Experimental | Behavioral: Modular mHealth for Tailored RehabilitationSelf-management (physical activity, sleep, exercise, education, etc.) using mHealth |
| Exercise using brochure | No intervention | –Only exercise using brochure |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral breast cancer at TNM stage 0 ~ III
- Patients who will undergo the treatment (chemotherapy, radiation therapy, and hormone therapy) after surgery
- Patients who had a mobile phone (Android or iOS)
Key exclusion criteria (1 listed)
- Patients who have metastases or recurrence to other organs were excluded
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 |
|---|---|---|
| Modular mHealth for Tailored RehabilitationAlso: mHealthan individually tailored self-management through the mHealth app with a smart band worn on the wrist | Behavioural | Self-management using mHealth |
Primary outcome
satisfaction score in app contents
Time frame: 1 to 12month
satisfaction score in app contents, Likert scale (5-point, higher scores mean a better)
Needs score in app contents
Time frame: 1 to 12month
Needs score in app contents, Likert scale (5-point, higher scores mean a better)
DASH (Disabilities of Arm, Shoulder, Hands)
Time frame: 1 month, 2month, 4month, 6month, 9month, 12month
Change from Baseline DASH score at 12 months, higher scores mean a worse (0-100)
11 secondary outcomes
Physical measurement (handgrip strength)
Time frame: 1 to 12month
Physical measurement (of body composition, BMI)
Time frame: 1 to 12month
Physical measurement (of body composition, muscle mass)
Time frame: 1 to 12month
Physical measurement (upper extremity volume)
Time frame: 1 to 12month
Physical activity (IPAQ-SF Questionnaire)
Time frame: 1 to 12month
PRO-CTCAE (patients reported outcomes)
Time frame: 1 to 12month
Distress thermometer (distress level)
Time frame: 1 to 12month
App use data (personal health record)_Exercise compliance rate
Time frame: 1 to 12month
App use data (personal health record)_Physical activity change
Time frame: 1 to 12month
App use data (personal health record)_interest of contents
Time frame: 1 to 12month
App use data (personal health record)_sleep
Time frame: 1 to 12month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
JIHYE HWANG, Professor study chair
Physical & Rehabilitation Medicine Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modular mHealth for Tailored Rehabilitation in people with 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 26 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
satisfaction score in app contents (time frame: 1 to 12month). The study lists 3 primary outcomes in all. 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 26 Oct 2022.