Feasibility of a Modular mHealth for Tailored Rehabilitation of Breast Cancer

NCT ID: NCT04781712

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-22

Study Completion Date

2021-03-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Self-management using mHealth

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

Group Type EXPERIMENTAL

Modular mHealth for Tailored Rehabilitation

Intervention Type BEHAVIORAL

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

Exercise using brochure

Only exercise using brochure

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Modular mHealth for Tailored Rehabilitation

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

Intervention Type BEHAVIORAL

Other Intervention Names

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mHealth

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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JiHye Hwang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JIHYE HWANG, Professor

Role: STUDY_CHAIR

Physical & Rehabilitation Medicine Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, Gangnam-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SMC-2018-10-062

Identifier Type: -

Identifier Source: org_study_id

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