AzTrials
AzTrials

Prostate CancerNCT03264209

Smart After-Care in Patients With Prostate Cancer

A study testing Smart After-Care (Mobile health) in people with Prostate Cancer, run by Ji Youl Lee at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Smart After-Care (Mobile health)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSouth Korea
Study dates
11 Sep 2017to Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Yong Hyun Park, MD, PhD contact

82-2-2258-6076

lestat04@catholic.ac.kr

South Korea1 site, 1 recruiting

  • Seoul St. Mary's Hospital

    Seoul, 06591

    Ji Youl Lee, 82-2-2258-6076, uroljy@catholic.ac.kr

    Yong Hyun Park, 82-2-2258-6076, lestat04@catholic.ac.kr

    Recruiting

Other trials in South Korea

About this study

Official title: Smart After-Care in Patients With Prostate Cancer: a Randomized Controlled Trial

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Smart After-Care (Mobile health)
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smart After-Care (Mobile health)Behavioural

    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.

Study groups in NCT03264209
Study groupRoleWhat they receive
Intervention: Case managementExperimentalCase management consists confirmation of hospital visit date, checking the efficacy of intervention, adverse effect and treatment compliance
Receives: Behavioral: Smart After-Care (Mobile health)
Control: usual careNo interventionUsual care is provided with life style intervention including exercise and nutrition by printed materials.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months after randomization

Secondary outcomes (5)

  1. 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.

    Measured: 3 months after randomization

  2. 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.

    Measured: 3 months after randomization

  3. Changes in body composition

    weight in kilograms, height in meters, body fat mass in kilograms, skeletal muscle mass in kilograms

    Measured: 3 months after randomization

  4. Changes in health-related quality of life by EORTC QLQ-C30

    Units on a Scale

    Measured: 3 months after randomization

  5. Changes in health-related quality of life by EORTC QLQ-PR25.

    Units on a Scale

    Measured: 3 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2017
  2. Study start11 Sep 2017
  3. Primary completionAug 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03264209
Sponsor's protocol ID
KC17FNDI0557
Status last verified
Sep 2017
First submitted
22 Aug 2017
Last updated
2 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Smart After-Care (Mobile health) in people with Prostate Cancer, run by Ji Youl Lee at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yong Hyun Park, MD, PhD (82-2-2258-6076, lestat04@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical function (2 minute walking test) (time frame: 3 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03264209.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in