Feasibility of a Modular mHealth for Tailored Rehabilitation of Breast Cancer (MMHTR)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Modular mHealth for Tailored Rehabilitation

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam-gu
    • Seoul, Gangnam-gu, Korea, Republic of, 06351
      • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Self-management using mHealth; Self-management (physical activity, sleep, exercise, education, etc.) using mHealth	Behavioral: Modular mHealth for Tailored Rehabilitation; an individually tailored self-management through the mHealth app with a smart band worn on the wrist; Other Names: mHealth
NO_INTERVENTION: Exercise using brochure; Only exercise using brochure

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 22, 2019
• Primary Completion (ACTUAL): March 30, 2021
• Study Completion (ACTUAL): March 30, 2021

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (ACTUAL): March 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SMC-2018-10-062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No