NCT03205969

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable breast-cancer

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

12 months

First QC Date

June 29, 2017

Last Update Submit

June 29, 2017

Conditions

Breast Cancer

Keywords

Breast Cancerchemotherapy side effectmobile game

Outcome Measures

Primary Outcomes (1)

  • International Physical Activity Questionnaires (IPAQ)

    To obtain comparable estimates of physical activity

    overall assessment period (3 weeks)

Secondary Outcomes (1)

  • Beck Depression Inventory (BDI)

    overall assessment period (3 weeks)

Study Arms (1)

Functional mobile game

EXPERIMENTAL

Functional mobile game for chemotherapy side effect education

Device: Functional mobile game

Interventions

Functional mobile gameDEVICE

Functional mobile game for chemotherapy side effect education

Functional mobile game

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 24165030BACKGROUND

  • Beutel ME, Weissflog G, Leuteritz K, Wiltink J, Haselbacher A, Ruckes C, Kuhnt S, Barthel Y, Imruck BH, Zwerenz R, Brahler E. Efficacy of short-term psychodynamic psychotherapy (STPP) with depressed breast cancer patients: results of a randomized controlled multicenter trial. Ann Oncol. 2014 Feb;25(2):378-84. doi: 10.1093/annonc/mdt526. Epub 2013 Dec 16.

    PMID: 24347520BACKGROUND

  • Segrin C, Badger TA. Psychological and physical distress are interdependent in breast cancer survivors and their partners. Psychol Health Med. 2014;19(6):716-23. doi: 10.1080/13548506.2013.871304. Epub 2014 Jan 2.

    PMID: 24383980BACKGROUND

  • DeNysschen CA, Burton H, Ademuyiwa F, Levine E, Tetewsky S, O'Connor T. Exercise intervention in breast cancer patients with aromatase inhibitor-associated arthralgia: a pilot study. Eur J Cancer Care (Engl). 2014 Jul;23(4):493-501. doi: 10.1111/ecc.12155. Epub 2013 Dec 2.

    PMID: 24289215BACKGROUND

  • Carayol M, Romieu G, Bleuse JP, Senesse P, Gourgou-Bourgade S, Sari C, Jacot W, Sancho-Garnier H, Janiszewski C, Launay S, Cousson-Gelie F, Ninot G. Adapted physical activity and diet (APAD) during adjuvant breast cancer therapy: design and implementation of a prospective randomized controlled trial. Contemp Clin Trials. 2013 Nov;36(2):531-43. doi: 10.1016/j.cct.2013.09.016. Epub 2013 Oct 4.

    PMID: 24096188BACKGROUND

  • Jung KW, Won YJ, Kong HJ, Oh CM, Seo HG, Lee JS. Cancer statistics in Korea: incidence, mortality, survival and prevalence in 2010. Cancer Res Treat. 2013 Mar;45(1):1-14. doi: 10.4143/crt.2013.45.1.1. Epub 2013 Mar 31.

    PMID: 23613665BACKGROUND

  • Hwang SY, Chang SJ, Park BW. Does chemotherapy really affect the quality of life of women with breast cancer? J Breast Cancer. 2013 Jun;16(2):229-35. doi: 10.4048/jbc.2013.16.2.229. Epub 2013 Jun 28.

    PMID: 23843858BACKGROUND

  • Kim HJ, Kim SM, Shin H, Jang JS, Kim YI, Han DH. A Mobile Game for Patients With Breast Cancer for Chemotherapy Self-Management and Quality-of-Life Improvement: Randomized Controlled Trial. J Med Internet Res. 2018 Oct 29;20(10):e273. doi: 10.2196/jmir.9559.

    PMID: 30578205DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jungsoon Jang, MD.PhD

    Professor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor,Division of Hemato-oncology

Study Record Dates

First Submitted

June 29, 2017

First Posted

July 2, 2017

Study Start

January 5, 2015

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

July 2, 2017

Record last verified: 2017-06