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Smart After-Care in Patients With Prostate Cancer

NCT ID: NCT03264209

Last Updated: 2017-10-02

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-11

Study Completion Date

2018-12-31

Brief Summary

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This study aims to examine whether Smart After-Care service (Internet-and mobile-based lifestyle intervention) has an effect on patients' satisfaction and clinical outcomes in patients with prostate cancer on androgen deprivation therapy. Patients with prostate cancer on androgen deprivation therapy will participate in the study. The study design is a randomized controlled trial. The patients were randomly assigned to intervention or usual care groups. Intervention patients received Smart After-Care service for 3 months. Primary endpoint was an increase in patients' physical function as assessed using 2 minute walking test. Secondary endpoints included improvement in muscle strength, short physical performance battery, body composition, and health-related quality of life.

Detailed Description

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After-care is a process targeted towards restoration or maintenance of the physical, mental, intellectual and social abilities of an individual affected by cancer. Internet-and mobile-based lifestyle intervention have emerged as potential modalities to complement and increase accessibility to after-care. In order to meet the growing need for after-care services, we developed a Smart after-care system that will assess the efficacy of a web-based smartphone-enabled intervention. The system provided specialized tools on after-care of prostate cancer including information on nutrition, physical activity, medication adherence, and mobile device that can connect to the smartphone. Patients with prostate cancer on androgen deprivation therapy will be screened for having adequate musculoskeletal and cardiopulmonary function.The study design is a randomized controlled trial. The patients were randomly assigned to intervention or usual care groups. Intervention patients received Smart After-Care management for 3 months. Primary endpoint was an increase in patients' physical function as assessed using 2 minute walking test. Secondary endpoints included improvement in muscle strength, short physical performance battery, body composition, and health-related quality of life.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention: Case management

Case management consists confirmation of hospital visit date, checking the efficacy of intervention, adverse effect and treatment compliance

Group Type EXPERIMENTAL

Smart After-Care (Mobile health)

Intervention Type BEHAVIORAL

Patients in intervention group will be provided with Smart After-Care Service including intervention for physical activity (aerobic exercise at least 90 or 150 minutes every week for 12 weeks depending on patients' aerobic fitness by monitoring with smartband and strengthening exercise at least 2 times a week for 12 weeks), information for prostate cancer and adequate life style, and smartband that can connect to the smartphone. Case management consists confirmation of hospital visit date, checking the adverse effect and treatment compliance.

Control: usual care

Usual care is provided with life style intervention including exercise and nutrition by printed materials.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Smart After-Care (Mobile health)

Patients in intervention group will be provided with Smart After-Care Service including intervention for physical activity (aerobic exercise at least 90 or 150 minutes every week for 12 weeks depending on patients' aerobic fitness by monitoring with smartband and strengthening exercise at least 2 times a week for 12 weeks), information for prostate cancer and adequate life style, and smartband that can connect to the smartphone. Case management consists confirmation of hospital visit date, checking the adverse effect and treatment compliance.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Males diagnosed with prostate cancer
* Current treatment with ADT (GnRH agonist/antagonist with or without antiandrogen) for a minimum of 6 months after randomization
* Having Android smartphone

Exclusion Criteria

* Having another (active) malignant disease within 3 month before randomization
* Having severe cardiopulmonary disease
* Having bone pain due to bone metastasis, (or) pathologic fracture
* Receiving total knee replacement arthroplasty, (or) total hip replacement arthroplasty
* No permission from treating/study physician to participate in exercise
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ji Youl Lee

OTHER

Sponsor Role lead

Responsible Party

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Ji Youl Lee

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ji Youl Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

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Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yong Hyun Park, MD, PhD

Role: CONTACT

[email protected]
82-2-2258-6076

Facility Contacts

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Ji Youl Lee

Role: primary

[email protected]
82-2-2258-6076

Yong Hyun Park

Role: backup

[email protected]
82-2-2258-6076

Other Identifiers

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KC17FNDI0557

Identifier Type: -

Identifier Source: org_study_id