Clinical trial NCT03264209: Smart After-Care in Patients With Prostate Cancer
Official title: Smart After-Care in Patients With Prostate Cancer: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 200
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical function (2 minute walking test)
timeFrame: 3 months after randomization
Secondary outcomes:
measure: Changes in muscle strength
timeFrame: 3 months after randomization
measure: Changes in short physical performance battery
timeFrame: 3 months after randomization
measure: Changes in body composition
timeFrame: 3 months after randomization
measure: Changes in health-related quality of life by EORTC QLQ-C30
timeFrame: 3 months after randomization
measure: Changes in health-related quality of life by EORTC QLQ-PR25.
timeFrame: 3 months after randomization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Ji Youl Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: