Smart After-Care in Patients With Prostate Cancer

Not Applicable

• Conditions: Prostate Cancer
• Interventions: Behavioral: Smart After-Care (Mobile health)

• Registration Number: NCT03264209
• Lead Sponsor: Ji Youl Lee

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-24
• Study First Posted: 2017-08-29
• Status Verified: 2017-09
• Study Start: 2017-09-11
• Last Update Submitted: 2017-09-28
• Last Update Posted: 2017-10-02
• Primary Completion: 2018-08
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention: Case management	Smart After-Care (Mobile health)	Case management consists confirmation of hospital visit date, checking the efficacy of intervention, adverse effect and treatment compliance

Primary Outcome Measures

Name	Time	Method
Physical function (2 minute walking test)	3 months after randomization	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.

Secondary Outcome Measures

Name	Time	Method
Changes in muscle strength	3 months after randomization	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.
Changes in short physical performance battery	3 months after randomization	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.
Changes in body composition	3 months after randomization	weight in kilograms, height in meters, body fat mass in kilograms, skeletal muscle mass in kilograms
Changes in health-related quality of life by EORTC QLQ-C30	3 months after randomization	Units on a Scale
Changes in health-related quality of life by EORTC QLQ-PR25.	3 months after randomization	Units on a Scale

Trial Locations

Locations (1)

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of