An interventional study of Modular mHealth for Tailored Rehabilitation in Breast Cancer, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-26.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Supportive care
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 44 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Self-management (physical activity, sleep, exercise, education, etc.) using mHealth
Behavioral: Modular mHealth for Tailored Rehabilitation
Only exercise using brochure
an individually tailored self-management through the mHealth app with a smart band worn on the wrist
Also known as: mHealth
satisfaction score in app contents
satisfaction score in app contents, Likert scale (5-point, higher scores mean a better)
Time frame: 1 to 12month
Needs score in app contents
Needs score in app contents, Likert scale (5-point, higher scores mean a better)
Time frame: 1 to 12month
DASH (Disabilities of Arm, Shoulder, Hands)
Change from Baseline DASH score at 12 months, higher scores mean a worse (0-100)
Time frame: 1 month, 2month, 4month, 6month, 9month, 12month
Physical measurement (handgrip strength)
Handgrip strength (kg)
Time frame: 1 to 12month
Physical measurement (of body composition, BMI)
Body mass index
Time frame: 1 to 12month
Physical measurement (of body composition, muscle mass)
muscle mass
Time frame: 1 to 12month
Physical measurement (upper extremity volume)
differences in arm circumference
Time frame: 1 to 12month
Physical activity (IPAQ-SF Questionnaire)
Total METs within recent 7 days (vigorous, moderate, walking, sitting), higher values mean a better
Time frame: 1 to 12month
PRO-CTCAE (patients reported outcomes)
Symptoms during treatment
Time frame: 1 to 12month
Distress thermometer (distress level)
Distress level during treatment, higher scores mean a worse (0-10)
Time frame: 1 to 12month
App use data (personal health record)_Exercise compliance rate
Exercise time, higher values mean a better
Time frame: 1 to 12month
App use data (personal health record)_Physical activity change
daily step count (number), higher values mean a better physical activity
Time frame: 1 to 12month
App use data (personal health record)_interest of contents
contents view (number), higher values mean a better compliance rate
Time frame: 1 to 12month
App use data (personal health record)_sleep
sleep compliance rate (%), higher values mean a better compliance rate
Time frame: 1 to 12month
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center