NCT03264209

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

September 11, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

August 22, 2017

Last Update Submit

September 28, 2017

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (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.

    3 months after randomization

Secondary Outcomes (5)

  • Changes in muscle strength

    3 months after randomization

  • Changes in short physical performance battery

    3 months after randomization

  • Changes in body composition

    3 months after randomization

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

    3 months after randomization

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

    3 months after randomization

Study Arms (2)

Intervention: Case management

EXPERIMENTAL

Case management consists confirmation of hospital visit date, checking the efficacy of intervention, adverse effect and treatment compliance

Behavioral: Smart After-Care (Mobile health)

Control: usual care

NO INTERVENTION

Usual care is provided with life style intervention including exercise and nutrition by printed materials.

Interventions

Smart After-Care (Mobile health)BEHAVIORAL

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.

Intervention: Case management

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Ji Youl Lee, MD, PhD

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Hyun Park, MD, PhD

CONTACT

82-2-2258-6076lestat04@catholic.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 22, 2017

First Posted

August 29, 2017

Study Start

September 11, 2017

Primary Completion

August 1, 2018

Study Completion

December 1, 2018

Last Updated

October 2, 2017

Record last verified: 2017-09

Locations

KR(1)