Feasibility of a Modular mHealth for Tailored Rehabilitation of Breast Cancer

Breast Cancer Clinical Trial

— MMHTR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04781712
• Other study ID #: SMC-2018-10-062
• Status: Completed
• Phase: N/A
• Start date: April 22, 2019
• Est. completion date: March 30, 2021

Study information

• Verified date: October 2022
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Modular mHealth for Tailored Rehabilitation
an individually tailored self-management through the mHealth app with a smart band worn on the wrist

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	satisfaction score in app contents	satisfaction score in app contents, Likert scale (5-point, higher scores mean a better)	1 to 12month
Primary	Needs score in app contents	Needs score in app contents, Likert scale (5-point, higher scores mean a better)	1 to 12month
Primary	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	Physical measurement (handgrip strength)	Handgrip strength (kg)	1 to 12month
Secondary	Physical measurement (of body composition, BMI)	Body mass index	1 to 12month
Secondary	Physical measurement (of body composition, muscle mass)	muscle mass	1 to 12month
Secondary	Physical measurement (upper extremity volume)	differences in arm circumference	1 to 12month
Secondary	Physical activity (IPAQ-SF Questionnaire)	Total METs within recent 7 days (vigorous, moderate, walking, sitting), higher values mean a better	1 to 12month
Secondary	PRO-CTCAE (patients reported outcomes)	Symptoms during treatment	1 to 12month
Secondary	Distress thermometer (distress level)	Distress level during treatment, higher scores mean a worse (0-10)	1 to 12month
Secondary	App use data (personal health record)_Exercise compliance rate	Exercise time, higher values mean a better	1 to 12month
Secondary	App use data (personal health record)_Physical activity change	daily step count (number), higher values mean a better physical activity	1 to 12month
Secondary	App use data (personal health record)_interest of contents	contents view (number), higher values mean a better compliance rate	1 to 12month
Secondary	App use data (personal health record)_sleep	sleep compliance rate (%), higher values mean a better compliance rate	1 to 12month