Breast CancerNCT03205969

Effects of Mobile Game on Life Quality of Cancer Patients

A study testing Functional mobile game in people with Breast Cancer, run by Chung-Ang University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 25 to 60 years
Conditions the study is for: Breast Cancer
What is being tested?: Functional mobile game
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: No sites listed yet
Study dates: 5 Jan 2015to 31 Dec 2015
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 25 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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.

Conditions: Breast Cancer
Being tested: Functional mobile game
Keywords: Breast Cancer, chemotherapy side effect, mobile game
Medical subject headings: Breast Neoplasms

What participants receive

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

Functional mobile gameDevice
Functional mobile game for chemotherapy side effect education

Study groups in NCT03205969
Study group	Role	What they receive
Functional mobile game	Experimental	Functional mobile game for chemotherapy side effect education Receives: Device: Functional mobile game

What is being measured

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

International Physical Activity Questionnaires (IPAQ)
To obtain comparable estimates of physical activity
Measured: overall assessment period (3 weeks)

Secondary outcomes (1)

Beck Depression Inventory (BDI)
Measured: overall assessment period (3 weeks)

Timeline

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

5 Jan 201531 Dec 2015

First posted2 Jul 2017
Study start5 Jan 2015
Primary completion31 Dec 2015
Study completion31 Dec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03205969
Sponsor's protocol ID: C2014147
Status last verified: Jun 2017
First submitted: 29 Jun 2017
Last updated: 2 Jul 2017
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

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.
PubMed 24165030
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.
PubMed 24347520
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.
PubMed 24383980
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.
PubMed 24289215
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.
PubMed 24096188
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.
PubMed 23613665
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.
PubMed 23843858
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.
PubMed 30578205

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
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Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
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RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study : Effects of Mobile Game for Chemotherapy Side Effect Education on Life Quality of Cancer Patients
ClinicalTrials.gov ID: NCT03205969
Acronym / sponsor ID: C2014147
Conditions: Breast Cancer
Keywords: Breast Cancer, chemotherapy side effect, mobile game
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Chung-Ang University HospitalUniversity, hospital or other
Study start: 5 Jan 2015 (actual)
Primary completion: 31 Dec 2015 (actual)
Study completion: 31 Dec 2015 (actual)
First posted: 2 Jul 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Functional mobile game	Experimental	Device: Functional mobile gameFunctional mobile game for chemotherapy side effect education

Who may qualify

Ages: 25 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Functional mobile gameFunctional mobile game for chemotherapy side effect education	Device	Functional mobile game

Primary outcome

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

1 secondary outcome

Beck Depression Inventory (BDI)
Time frame: overall assessment period (3 weeks)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
Background: PubMed 24165030Touillaud 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.
Background: PubMed 24347520Beutel 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.
Background: PubMed 24383980Segrin 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.
Background: PubMed 24289215DeNysschen 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.
Background: PubMed 24096188Carayol 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.
Background: PubMed 23613665Jung 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.
Background: PubMed 23843858Hwang 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.
Derived from this study: PubMed 30578205Kim 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.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jungsoon Jang, MD.PhD study chair

Professor

Questions about this trial

What is this clinical trial studying?

A study testing Functional mobile game in people with Breast Cancer, run by Chung-Ang University Hospital.

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: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Physical Activity Questionnaires (IPAQ) (time frame: overall assessment period (3 weeks)). 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 NCT03205969, which also lists 8 linked publications.

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 Jul 2017.