Effects of Mobile Game on Life Quality of Cancer Patients | NCT03205969

Studies
Effects of Mobile Game on Life Quality of Cancer Patients

NCT03205969

Sponsor

Chung-Ang University Hospital

Status

Completed

Last Update Posted

Jul 2, 2017Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Functional mobile game

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 5, 2015Actual

Primary Completion Date

Dec 31, 2015Actual

Completion Date

Dec 31, 2015Actual

First Submitted Date

Jun 29, 2017

First Submission Date that Met QC Criteria

Jun 29, 2017

First Posted Date

Jul 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2017

Last Update Posted Date

Jul 2, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jung Soon Jang, Professor,Division of Hemato-oncology, Chung-Ang University HospitalPrincipal Investigator

Lead Sponsor

Chung-Ang University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether functional games can be used to improve the adherence and quality of life of breast cancer patients with chemotherapy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Functional mobile game	Experimental	Functional mobile game for chemotherapy side effect education	Device: Functional mobile game

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Functional mobile game	Device	Functional mobile game for chemotherapy side effect education	Functional mobile game

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
International Physical Activity Questionnaires (IPAQ)	To obtain comparable estimates of physical activity	overall assessment period (3 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Beck Depression Inventory (BDI)		overall assessment period (3 weeks)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with breast cancer
Receiving breast cancer chemotherapy
Patients who are using a smartphone and agree to use a mobile functional game

Exclusion Criteria:

Patient with intellectual disability
Diagnosed with congenital genetic disease
Patients with a history of acquired brain injury such as cerebral palsy
Developmental disorders, including autism
Patients with language or learning disabilities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jungsoon Jang, MD.PhD	Professor	Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24165030	Background	Touillaud M, Foucaut AM, Berthouze SE, Reynes E, Kempf-Lepine AS, Carretier J, Perol D, Guillemaut S, Chabaud S, Bourne-Branchu V, Perrier L, Tredan O, Fervers B, Bachmann P. Design of a randomised controlled trial of adapted physical activity during adjuvant treatment for localised breast cancer: the PASAPAS feasibility study. BMJ Open. 2013 Oct 28;3(10):e003855. doi: 10.1136/bmjopen-2013-003855.
24347520

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases