Smart After-Care in Patients With Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Smart After-Care (Mobile health)
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer
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
Sites / Locations
- Seoul St. Mary's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention: Case management
Control: usual care
Arm Description
Case management consists confirmation of hospital visit date, checking the efficacy of intervention, adverse effect and treatment compliance
Usual care is provided with life style intervention including exercise and nutrition by printed materials.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Changes in body composition
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
Units on a Scale
Changes in health-related quality of life by EORTC QLQ-PR25.
Units on a Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03264209
Brief Title
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
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 11, 2017 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ji Youl Lee
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention: Case management
Arm Type
Experimental
Arm Description
Case management consists confirmation of hospital visit date, checking the efficacy of intervention, adverse effect and treatment compliance
Arm Title
Control: usual care
Arm Type
No Intervention
Arm Description
Usual care is provided with life style intervention including exercise and nutrition by printed materials.
Intervention Type
Behavioral
Intervention Name(s)
Smart After-Care (Mobile health)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical function (2 minute walking test)
Description
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
Secondary Outcome Measure Information:
Title
Changes in muscle strength
Description
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
Title
Changes in short physical performance battery
Description
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
Title
Changes in body composition
Description
weight in kilograms, height in meters, body fat mass in kilograms, skeletal muscle mass in kilograms
Time Frame
3 months after randomization
Title
Changes in health-related quality of life by EORTC QLQ-C30
Description
Units on a Scale
Time Frame
3 months after randomization
Title
Changes in health-related quality of life by EORTC QLQ-PR25.
Description
Units on a Scale
Time Frame
3 months after randomization
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Hyun Park, MD, PhD
Phone
82-2-2258-6076
Email
lestat04@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Youl Lee, MD, PhD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Youl Lee
Phone
82-2-2258-6076
Email
uroljy@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Yong Hyun Park
Phone
82-2-2258-6076
Email
lestat04@catholic.ac.kr
12. IPD Sharing Statement
Learn more about this trial
Smart After-Care in Patients With Prostate Cancer
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