Feasibility of a Modular mHealth for Tailored Rehabilitation of Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility of a Modular mHealth for Tailored Rehabilitation During the Treatment of Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Modular mHealth for Tailored Rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-management using mHealth<br>Self-management (physical activity, sleep, exercise, education, etc.) using mHealth | Behavioral: Modular mHealth for Tailored Rehabilitation<br>* an individually tailored self-management through the mHealth app with a smart band worn on the wrist<br>* Other names: mHealth;|
| No Intervention: Exercise using brochure<br>Only exercise using brochure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction score in app contents | satisfaction score in app contents, Likert scale (5-point, higher scores mean a better) | 1 to 12month | 
| Needs score in app contents | Needs score in app contents, Likert scale (5-point, higher scores mean a better) | 1 to 12month | 
| DASH (Disabilities of Arm, Shoulder, Hands) | Change from Baseline DASH score at 12 months, higher scores mean a worse (0-100) | 1 month, 2month, 4month, 6month, 9month, 12month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical measurement (handgrip strength) | Handgrip strength (kg) | 1 to 12month | 
| Physical measurement (of body composition, BMI) | Body mass index | 1 to 12month | 
| Physical measurement (of body composition, muscle mass) | muscle mass | 1 to 12month | 
| Physical measurement (upper extremity volume) | differences in arm circumference | 1 to 12month | 
| Physical activity (IPAQ-SF Questionnaire) | Total METs within recent 7 days (vigorous, moderate, walking, sitting), higher values mean a better | 1 to 12month | 
| PRO-CTCAE (patients reported outcomes) | Symptoms during treatment | 1 to 12month | 
| Distress thermometer (distress level) | Distress level during treatment, higher scores mean a worse (0-10) | 1 to 12month | 
| App use data (personal health record)_Exercise compliance rate | Exercise time, higher values mean a better | 1 to 12month | 
| App use data (personal health record)_Physical activity change | daily step count (number), higher values mean a better physical activity | 1 to 12month | 
| App use data (personal health record)_interest of contents | contents view (number), higher values mean a better compliance rate | 1 to 12month | 
| App use data (personal health record)_sleep | sleep compliance rate (%), higher values mean a better compliance rate | 1 to 12month |