- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03205969
Effects of Mobile Game on Life Quality of Cancer Patients
June 29, 2017 updated by: Jung Soon Jang, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Pilot Study : Effects of Mobile Game for Chemotherapy Side Effect Education on Life Quality of Cancer Patients
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Functional mobile game
Functional mobile game for chemotherapy side effect education
|
Functional mobile game for chemotherapy side effect education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
International Physical Activity Questionnaires (IPAQ)
Time Frame: overall assessment period (3 weeks)
|
To obtain comparable estimates of physical activity
|
overall assessment period (3 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Beck Depression Inventory (BDI)
Time Frame: overall assessment period (3 weeks)
|
overall assessment period (3 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Jungsoon Jang, MD.PhD, PROFESSOR
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2015
Primary Completion (Actual)
December 31, 2015
Study Completion (Actual)
December 31, 2015
Study Registration Dates
First Submitted
June 29, 2017
First Submitted That Met QC Criteria
June 29, 2017
First Posted (Actual)
July 2, 2017
Study Record Updates
Last Update Posted (Actual)
July 2, 2017
Last Update Submitted That Met QC Criteria
June 29, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- C2014147
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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