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Completed

NCT Number: NCT04781712

Feasibility of a Modular mHealth for Tailored Rehabilitation 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modular mHealth for Tailored Rehabilitation

Behavioral

an individually tailored self-management through the mHealth app with a smart band worn on the wrist

Other names: mHealth

Primary outcomes

  1. satisfaction score in app contents

    Time frame: 1 to 12month

    satisfaction score in app contents, Likert scale (5-point, higher scores mean a better)

  2. Needs score in app contents

    Time frame: 1 to 12month

    Needs score in app contents, Likert scale (5-point, higher scores mean a better)

  3. DASH (Disabilities of Arm, Shoulder, Hands)

    Time frame: 1 month, 2month, 4month, 6month, 9month, 12month

    Change from Baseline DASH score at 12 months, higher scores mean a worse (0-100)

Secondary outcomes

  1. Physical measurement (handgrip strength)

    Time frame: 1 to 12month

    Handgrip strength (kg)

  2. Physical measurement (of body composition, BMI)

    Time frame: 1 to 12month

    Body mass index

  3. Physical measurement (of body composition, muscle mass)

    Time frame: 1 to 12month

    muscle mass

  4. Physical measurement (upper extremity volume)

    Time frame: 1 to 12month

    differences in arm circumference

  5. Physical activity (IPAQ-SF Questionnaire)

    Time frame: 1 to 12month

    Total METs within recent 7 days (vigorous, moderate, walking, sitting), higher values mean a better

  6. PRO-CTCAE (patients reported outcomes)

    Time frame: 1 to 12month

    Symptoms during treatment

  7. Distress thermometer (distress level)

    Time frame: 1 to 12month

    Distress level during treatment, higher scores mean a worse (0-10)

  8. App use data (personal health record)_Exercise compliance rate

    Time frame: 1 to 12month

    Exercise time, higher values mean a better

  9. App use data (personal health record)_Physical activity change

    Time frame: 1 to 12month

    daily step count (number), higher values mean a better physical activity

  10. App use data (personal health record)_interest of contents

    Time frame: 1 to 12month

    contents view (number), higher values mean a better compliance rate

  11. App use data (personal health record)_sleep

    Time frame: 1 to 12month

    sleep compliance rate (%), higher values mean a better compliance rate

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Acronym: MMHTR

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2021
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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