Feasibility of a Modular mHealth for Tailored Rehabilitation of Breast Cancer
MMHTR
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2019
CompletedFirst Submitted
Initial submission to the registry
February 22, 2021
CompletedFirst Posted
Study publicly available on registry
March 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2021
CompletedOctober 26, 2022
October 1, 2022
1.9 years
February 22, 2021
October 25, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (11)
Physical measurement (handgrip strength)
1 to 12month
Physical measurement (of body composition, BMI)
1 to 12month
Physical measurement (of body composition, muscle mass)
1 to 12month
Physical measurement (upper extremity volume)
1 to 12month
Physical activity (IPAQ-SF Questionnaire)
1 to 12month
- +6 more secondary outcomes
Study Arms (2)
Self-management using mHealth
EXPERIMENTALSelf-management (physical activity, sleep, exercise, education, etc.) using mHealth
Exercise using brochure
NO INTERVENTIONOnly exercise using brochure
Interventions
an individually tailored self-management through the mHealth app with a smart band worn on the wrist
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- \- Patients who have metastases or recurrence to other organs were excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, Gangnam-gu, 06351, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
JIHYE HWANG, Professor
Physical & Rehabilitation Medicine Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 22, 2021
First Posted
March 4, 2021
Study Start
April 22, 2019
Primary Completion
March 30, 2021
Study Completion
March 30, 2021
Last Updated
October 26, 2022
Record last verified: 2022-10