Breast Cancer
Conditions
Brief 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.
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.
Interventions
BEHAVIORALModular mHealth for Tailored Rehabilitation
an individually tailored self-management through the mHealth app with a smart band worn on the wrist
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
\- Patients who have metastases or recurrence to other organs were excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| satisfaction score in app contents | 1 to 12month | satisfaction score in app contents, Likert scale (5-point, higher scores mean a better) |
| Needs score in app contents | 1 to 12month | Needs score in app contents, Likert scale (5-point, higher scores mean a better) |
| DASH (Disabilities of Arm, Shoulder, Hands) | 1 month, 2month, 4month, 6month, 9month, 12month | Change from Baseline DASH score at 12 months, higher scores mean a worse (0-100) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical measurement (upper extremity volume) | 1 to 12month | differences in arm circumference |
| Physical activity (IPAQ-SF Questionnaire) | 1 to 12month | Total METs within recent 7 days (vigorous, moderate, walking, sitting), higher values mean a better |
| PRO-CTCAE (patients reported outcomes) | 1 to 12month | Symptoms during treatment |
| Distress thermometer (distress level) | 1 to 12month | Distress level during treatment, higher scores mean a worse (0-10) |
| Physical measurement (handgrip strength) | 1 to 12month | Handgrip strength (kg) |
| App use data (personal health record)_Physical activity change | 1 to 12month | daily step count (number), higher values mean a better physical activity |
| App use data (personal health record)_interest of contents | 1 to 12month | contents view (number), higher values mean a better compliance rate |
| App use data (personal health record)_sleep | 1 to 12month | sleep compliance rate (%), higher values mean a better compliance rate |
| App use data (personal health record)_Exercise compliance rate | 1 to 12month | Exercise time, higher values mean a better |
| Physical measurement (of body composition, BMI) | 1 to 12month | Body mass index |
| Physical measurement (of body composition, muscle mass) | 1 to 12month | muscle mass |
Countries
South Korea
Outcome results
None listed