An interventional study of Smart After-Care (Mobile health) in Prostate Cancer, sponsored by Ji Youl Lee. Status unknown at 1 site in Korea, Republic of. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-10-02.
Sponsored by Ji Youl Lee · Not applicable, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
Case management consists confirmation of hospital visit date, checking the efficacy of intervention, adverse effect and treatment compliance
Behavioral: Smart After-Care (Mobile health)
Usual care is provided with life style intervention including exercise and nutrition by printed materials.
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.
Physical function (2 minute walking test)
Cardiorespiratory endurance was examined by 2MWT performed on a 15.2-m hallway out-and-back course. Patients were instructed to walk as fast as they could until asked to stop at 2 min; the distance covered was recorded.
Time frame: 3 months after randomization
Changes in muscle strength
A handgrip strength test was used to assess upper extremity muscle strength using a hand-held dynamometer. Patients were instructed to apply maximal power for 3 s with the shoulder adducted and neutrally rotated, elbow flexed at 90°, and the forearm and wrist in a neutral position. Three attempts were given with each hand and the best score (kg) for each was recorded. A 30-s chair stand test was used as a measure of lower extremity muscle strength. Each patient was seated in the middle of the chair (seat height of 40 cm, without armrests but with a backrest) with their back straight and both arms folded across their chest. The patients were instructed to stand up and sit down repetitively and encouraged to complete as many full stands as possible for 30 s while the instructor kept count.
Time frame: 3 months after randomization
Changes in short physical performance battery
The SPPB is calculated from three components: the ability to stand for up to 10 seconds with feet positioned in three ways (together side-by-side, semi-tandem and tandem); time to complete a 3-m or 4-m walk; and time to rise from a chair five times.
Time frame: 3 months after randomization
Changes in body composition
weight in kilograms, height in meters, body fat mass in kilograms, skeletal muscle mass in kilograms
Time frame: 3 months after randomization
Changes in health-related quality of life by EORTC QLQ-C30
Units on a Scale
Time frame: 3 months after randomization
Changes in health-related quality of life by EORTC QLQ-PR25.
Units on a Scale
Time frame: 3 months after randomization
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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