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Smart After-Care in Patients With Prostate Cancer

J

Ji Youl Lee

Status

Unknown

Conditions

Prostate Cancer

Treatments

Behavioral: Smart After-Care (Mobile health)

Study type

Interventional

Funder types

Other

Identifiers

NCT03264209
KC17FNDI0557

Details and patient eligibility

About

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.

Full description

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.

Enrollment

200 estimated patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

Intervention: Case management
Experimental group
Description:
Case management consists confirmation of hospital visit date, checking the efficacy of intervention, adverse effect and treatment compliance
Treatment:
Behavioral: Smart After-Care (Mobile health)
Control: usual care
No Intervention group
Description:
Usual care is provided with life style intervention including exercise and nutrition by printed materials.

Trial contacts and locations

1

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Central trial contact

Yong Hyun Park, MD, PhD

Data sourced from clinicaltrials.gov

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