Mobile Application Support for Women With Breast Cancer Undergoing Chemotherapy

NCT ID: NCT05072197

Last Updated: 2023-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-16

Study Completion Date

2023-12-31

Brief Summary

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Mobile phones have become an essential tool for everyday life. The convenience and easy accessibility of the data and information received through mobile phones have made mobile applications as the latest trend to provide education for patients in medical centers. In Taiwan, breast cancer incidence has been the highest among all cancers and the fourth leading cause of cancer deaths in women. Women with breast cancer who are undergoing chemotherapy suffer from a number of symptoms throughout the chemotherapy treatment that detrimentally affects their quality of life. Thus, providing social support and nursing care aids for these vulnerable women is imperative to help them face their breast cancer challenges. This study will develop a Mobile device application providing medical care information and social support for breast cancer women during their chemotherapy treatment to help them receive individually tailored information related to chemotherapy and support from healthcare professionals and peers. This study will use a mixed-methods design to develop a Mobile device application based on breast cancer literature and the clinical experiences of breast cancer patients to fulfill the needs women may experience during the chemotherapy treatment. Women with breast cancer will be invited to help refine the Mobile device application's content based on their experiences and feedback about the mobile application. Upon completing the mobile application development, women with breast cancer patients will be recruited to participate in a randomized controlled trial to examine the effectiveness of the mobile application. The results of this study will provide a foundation to deliver a remote, personalized, and continuous health care model to improve the self-efficacy, social support, and quality of life of women with breast cancer, and ultimately enhancing the overall quality of care and patient satisfaction with the medical care participants receive.

Detailed Description

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This application has four modules: 1) a Learning forum; 2) a Ask-the-Expert forum; 3) a Website link forum; 4) a Encouragement forum. The intervention group will receive routine care plus access to the "B with you" program during their six cycles of chemotherapy. Self-efficacy, social support, and quality of life will be measured at baseline, then the 3rd and 6th cycles of chemotherapy.

Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Mobile device application group

routine care and mobile device application providing medical care information and social support for breast cancer women during their chemotherapy treatment

Group Type EXPERIMENTAL

Mobile device as a support tool for the treatment of women with breast cancer undergoing chemotherapy

Intervention Type DEVICE

This study will develop a Mobile device application providing medical care information and social support for breast cancer women during their chemotherapy treatment to help them receive individually tailored information related to chemotherapy and support from healthcare professionals and peers.

control group

routine care for breast cancer women during their chemotherapy treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mobile device as a support tool for the treatment of women with breast cancer undergoing chemotherapy

This study will develop a Mobile device application providing medical care information and social support for breast cancer women during their chemotherapy treatment to help them receive individually tailored information related to chemotherapy and support from healthcare professionals and peers.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* at least 20 years of age.
* diagnosed with breast cancer for the first time.
* treated with chemotherapy at the study sites.
* able to access the internet with a mobile phone.
* Fluent in spoken and written Chinese .

Exclusion Criteria

* patients with cognitive dysfunction.
* diagnosed mental health problems.
* having with other cancers.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cheng-Hsin General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ya-Hui Liang, BS

Role: PRINCIPAL_INVESTIGATOR

Cheng-Hsin General Hospital

Locations

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Cheng Hsin General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ya-Hui Liang, BS

Role: CONTACT

+886952823710

Chun-Yi Tai, Ph.D

Role: CONTACT

+886-228227101 ext. 3171

Facility Contacts

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Ya-Hui Liang, BS

Role: primary

+886952823710

References

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Akechi T, Yamaguchi T, Uchida M, Imai F, Momino K, Katsuki F, Sakurai N, Miyaji T, Horikoshi M, Furukawa TA, Iwata H, Uchitomi Y. Smartphone problem-solving and behavioural activation therapy to reduce fear of recurrence among patients with breast cancer (SMartphone Intervention to LEssen fear of cancer recurrence: SMILE project): protocol for a randomised controlled trial. BMJ Open. 2018 Nov 8;8(11):e024794. doi: 10.1136/bmjopen-2018-024794.

Reference Type BACKGROUND
PMID: 30413519 (View on PubMed)

Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Long-term outcomes for neoadjuvant versus adjuvant chemotherapy in early breast cancer: meta-analysis of individual patient data from ten randomised trials. Lancet Oncol. 2018 Jan;19(1):27-39. doi: 10.1016/S1470-2045(17)30777-5. Epub 2017 Dec 11.

Reference Type BACKGROUND
PMID: 29242041 (View on PubMed)

Binotto M, Reinert T, Werutsky G, Zaffaroni F, Schwartsmann G. Health-related quality of life before and during chemotherapy in patients with early-stage breast cancer. Ecancermedicalscience. 2020 Jan 27;14:1007. doi: 10.3332/ecancer.2020.1007. eCollection 2020.

Reference Type BACKGROUND
PMID: 32104209 (View on PubMed)

Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.

Reference Type BACKGROUND
PMID: 9060536 (View on PubMed)

Handa S, Okuyama H, Yamamoto H, Nakamura S, Kato Y. Effectiveness of a Smartphone Application as a Support Tool for Patients Undergoing Breast Cancer Chemotherapy: A Randomized Controlled Trial. Clin Breast Cancer. 2020 Jun;20(3):201-208. doi: 10.1016/j.clbc.2020.01.004. Epub 2020 Feb 26.

Reference Type BACKGROUND
PMID: 32201165 (View on PubMed)

Hou IC, Lin HY, Shen SH, Chang KJ, Tai HC, Tsai AJ, Dykes PC. Quality of Life of Women After a First Diagnosis of Breast Cancer Using a Self-Management Support mHealth App in Taiwan: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Mar 4;8(3):e17084. doi: 10.2196/17084.

Reference Type BACKGROUND
PMID: 32130181 (View on PubMed)

Ng R, Lee CF, Wong NS, Luo N, Yap YS, Lo SK, Chia WK, Yee A, Krishna L, Goh C, Cheung YB. Measurement properties of the English and Chinese versions of the Functional Assessment of Cancer Therapy-Breast (FACT-B) in Asian breast cancer patients. Breast Cancer Res Treat. 2012 Jan;131(2):619-25. doi: 10.1007/s10549-011-1764-z. Epub 2011 Sep 16.

Reference Type BACKGROUND
PMID: 21922244 (View on PubMed)

Sakai H, Umeda M, Okuyama H, Nakamura S. Differences in perception of breast cancer treatment between patients, physicians, and nurses and unmet information needs in Japan. Support Care Cancer. 2020 May;28(5):2331-2338. doi: 10.1007/s00520-019-05029-z. Epub 2019 Sep 3.

Reference Type BACKGROUND
PMID: 31482403 (View on PubMed)

Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849.

Reference Type BACKGROUND
PMID: 27287964 (View on PubMed)

Yanez B, Oswald LB, Baik SH, Buitrago D, Iacobelli F, Perez-Tamayo A, Guitelman J, Penedo FJ, Buscemi J. Brief culturally informed smartphone interventions decrease breast cancer symptom burden among Latina breast cancer survivors. Psychooncology. 2020 Jan;29(1):195-203. doi: 10.1002/pon.5281. Epub 2019 Nov 15.

Reference Type BACKGROUND
PMID: 31693265 (View on PubMed)

Wan C, Zhang D, Yang Z, Tu X, Tang W, Feng C, Wang H, Tang X. Validation of the simplified Chinese version of the FACT-B for measuring quality of life for patients with breast cancer. Breast Cancer Res Treat. 2007 Dec;106(3):413-8. doi: 10.1007/s10549-007-9511-1. Epub 2007 Mar 22.

Reference Type BACKGROUND
PMID: 17377841 (View on PubMed)

Other Identifiers

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(818)109A-57

Identifier Type: -

Identifier Source: org_study_id

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