Feasibility of a Modular mHealth for Tailored Rehabilitation of Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Modular mHealth for Tailored Rehabilitation

• Registration Number: NCT04781712
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2019-04-22
• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-04
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-management using mHealth	Modular mHealth for Tailored Rehabilitation	Self-management (physical activity, sleep, exercise, education, etc.) using mHealth

Primary Outcome Measures

Name	Time	Method
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)
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)

Secondary Outcome Measures

Name	Time	Method
Physical measurement (of body composition, BMI)	1 to 12month	Body mass index
Physical measurement (upper extremity volume)	1 to 12month	differences in arm circumference
Physical measurement (handgrip strength)	1 to 12month	Handgrip strength (kg)
Physical measurement (of body composition, muscle mass)	1 to 12month	muscle mass
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)
App use data (personal health record)_Exercise compliance rate	1 to 12month	Exercise time, higher values mean a better
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)_sleep	1 to 12month	sleep compliance rate (%), higher values mean a better compliance rate
App use data (personal health record)_interest of contents	1 to 12month	contents view (number), higher values mean a better compliance rate

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Gangnam-gu, Korea, Republic of