Clinical trial NCT04781712: Feasibility of a Modular mHealth for Tailored Rehabilitation of Breast Cancer
Official title: Feasibility of a Modular mHealth for Tailored Rehabilitation During the Treatment of Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 44
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: satisfaction score in app contents
timeFrame: 1 to 12month
measure: Needs score in app contents
timeFrame: 1 to 12month
measure: DASH (Disabilities of Arm, Shoulder, Hands)
timeFrame: 1 month, 2month, 4month, 6month, 9month, 12month
Secondary outcomes:
measure: Physical measurement (handgrip strength)
timeFrame: 1 to 12month
measure: Physical measurement (of body composition, BMI)
timeFrame: 1 to 12month
measure: Physical measurement (of body composition, muscle mass)
timeFrame: 1 to 12month
measure: Physical measurement (upper extremity volume)
timeFrame: 1 to 12month
measure: Physical activity (IPAQ-SF Questionnaire)
timeFrame: 1 to 12month
measure: PRO-CTCAE (patients reported outcomes)
timeFrame: 1 to 12month
measure: Distress thermometer (distress level)
timeFrame: 1 to 12month
measure: App use data (personal health record)_Exercise compliance rate
timeFrame: 1 to 12month
measure: App use data (personal health record)_Physical activity change
timeFrame: 1 to 12month
measure: App use data (personal health record)_interest of contents
timeFrame: 1 to 12month
measure: App use data (personal health record)_sleep
timeFrame: 1 to 12month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
Study officials:
affiliation: Physical & Rehabilitation Medicine Samsung Medical Center
name: JIHYE HWANG, Professor
role: STUDY_CHAIR
References: