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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Modular mHealth for Tailored Rehabilitation
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Self-management using mHealth

Exercise using brochure

Arm Description

Self-management (physical activity, sleep, exercise, education, etc.) using mHealth

Only exercise using brochure

Outcomes

Primary Outcome Measures

satisfaction score in app contents
satisfaction score in app contents, Likert scale (5-point, higher scores mean a better)
Needs score in app contents
Needs score in app contents, Likert scale (5-point, higher scores mean a better)
DASH (Disabilities of Arm, Shoulder, Hands)
Change from Baseline DASH score at 12 months, higher scores mean a worse (0-100)

Secondary Outcome Measures

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

Full Information

First Posted
February 22, 2021
Last Updated
October 25, 2022
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04781712
Brief Title
Feasibility of a Modular mHealth for Tailored Rehabilitation of Breast Cancer
Acronym
MMHTR
Official Title
Feasibility of a Modular mHealth for Tailored Rehabilitation During the Treatment of Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 22, 2019 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-management using mHealth
Arm Type
Experimental
Arm Description
Self-management (physical activity, sleep, exercise, education, etc.) using mHealth
Arm Title
Exercise using brochure
Arm Type
No Intervention
Arm Description
Only exercise using brochure
Intervention Type
Behavioral
Intervention Name(s)
Modular mHealth for Tailored Rehabilitation
Other Intervention Name(s)
mHealth
Intervention Description
an individually tailored self-management through the mHealth app with a smart band worn on the wrist
Primary Outcome Measure Information:
Title
satisfaction score in app contents
Description
satisfaction score in app contents, Likert scale (5-point, higher scores mean a better)
Time Frame
1 to 12month
Title
Needs score in app contents
Description
Needs score in app contents, Likert scale (5-point, higher scores mean a better)
Time Frame
1 to 12month
Title
DASH (Disabilities of Arm, Shoulder, Hands)
Description
Change from Baseline DASH score at 12 months, higher scores mean a worse (0-100)
Time Frame
1 month, 2month, 4month, 6month, 9month, 12month
Secondary Outcome Measure Information:
Title
Physical measurement (handgrip strength)
Description
Handgrip strength (kg)
Time Frame
1 to 12month
Title
Physical measurement (of body composition, BMI)
Description
Body mass index
Time Frame
1 to 12month
Title
Physical measurement (of body composition, muscle mass)
Description
muscle mass
Time Frame
1 to 12month
Title
Physical measurement (upper extremity volume)
Description
differences in arm circumference
Time Frame
1 to 12month
Title
Physical activity (IPAQ-SF Questionnaire)
Description
Total METs within recent 7 days (vigorous, moderate, walking, sitting), higher values mean a better
Time Frame
1 to 12month
Title
PRO-CTCAE (patients reported outcomes)
Description
Symptoms during treatment
Time Frame
1 to 12month
Title
Distress thermometer (distress level)
Description
Distress level during treatment, higher scores mean a worse (0-10)
Time Frame
1 to 12month
Title
App use data (personal health record)_Exercise compliance rate
Description
Exercise time, higher values mean a better
Time Frame
1 to 12month
Title
App use data (personal health record)_Physical activity change
Description
daily step count (number), higher values mean a better physical activity
Time Frame
1 to 12month
Title
App use data (personal health record)_interest of contents
Description
contents view (number), higher values mean a better compliance rate
Time Frame
1 to 12month
Title
App use data (personal health record)_sleep
Description
sleep compliance rate (%), higher values mean a better compliance rate
Time Frame
1 to 12month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JIHYE HWANG, Professor
Organizational Affiliation
Physical & Rehabilitation Medicine Samsung Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Feasibility of a Modular mHealth for Tailored Rehabilitation of Breast Cancer

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