An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy

Breast Cancer Clinical Trial

Official title:

An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05258461
• Other study ID #: Smart
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: December 7, 2022

Study information

• Verified date: February 2022
• Source: Peking Union Medical College Hospital
• Contact: Yan Li, Doctor
• Phone: +86 17600352101
• Email: liyan0551[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate benefits of the app in breast cancer patients receiving the docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy. The investigators hypothesized that the addition of the app to conventional adverse event management would increase quality of life (QoL) scores and reduce adverse events.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: December 7, 2022
• Est. primary completion date: October 7, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. pathological diagnosis of invasive breast cancer

2. breast surgery within the past 2-8 weeks

3. adult female

4. must be able to use mobile phones

5. speak and write Chinese fluently to sign the informed consent

Exclusion Criteria:

1. severe comorbidity that interferes with outcome evaluation

2. insufficient Chinese language skills

3. inability to use mobile phones

4. cognitive disability to give informed consent

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• use of a smartphone app for adverse event management
At their enrollment, patients will receive detailed introduction and adequate assistance on the use of the smartphone app. The smartphone app will offer proper advice for adverse event management based on calculated results by artificial intelligence on the innovative app, which was developed by YL et al. It was specifically intended for risk prediction, early prevention, as well as management of symptoms and concerns during adjuvant chemotherapy in the treatment of breast cancer. The app consisted of 4 modules: (1) Module 1: clinical data collection. (2) Module 2: risk evaluation for 12 common adverse events during breast cancer chemotherapy. (3) Module 3: personalized prophylaxis based on predicted risks of adverse events. (4) Module 4: Q&A platform.
• conventional adverse event management
Chemotherapy-related adverse events in the control group will be managed with symptomatic treatment, dietary and lifestyle prescription according to the doctors' clinical experience. For example, colony-stimulating factors and antibiotics may be used for febrile neutropenia, loperamide (or diphenoxylate plus atropine) as prophylaxis for diarrhea, together with eating low-lactose and low-fat frequent small meals. 5-hydroxytryptamine 3 receptor antagonist, neurokinin 1 receptor antagonist, and/or dexamethasone would be prescribed for patients at high risks of vomiting.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

References & Publications (2)

Cheng JX, Liu BL, Zhang X, Zhang YQ, Lin W, Wang R, Zhang YQ, Zhang HY, Xie L, Huo JL. The validation of the standard Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) in pre-operative patients with brain tumor in China. BMC Med Res Methodol. 2011 Apr 22;11:56. doi: 10.1186/1471-2288-11-56. — View Citation

Wan C, Meng Q, Yang Z, Tu X, Feng C, Tang X, Zhang C. Validation of the simplified Chinese version of EORTC QLQ-C30 from the measurements of five types of inpatients with cancer. Ann Oncol. 2008 Dec;19(12):2053-60. doi: 10.1093/annonc/mdn417. Epub 2008 Jul 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Login times	Login times to the application during chemotherapy	Documented automatically by the application every two weeks
Other	Average time spent on the application	Average time spent on the application each time	Documented automatically by the application every two weeks
Other	Questions addressed on the Q&A platform	Questions addressed on the Q&A platform	Documented automatically by the application every two weeks
Primary	Change from baseline quality of life scores at 4 months	Quality of life scores will be assessed using the simplified Chinese version of the Organization for Research and Treatment of Cancer (EORTC QLQ-C30, version 3).	1 day before the first cycle, and 4 months after the first cycle (each cycle is 21 days)
Secondary	Incidence and severity of 12 common adverse events	The incidence and severity of 12 common adverse events will be measured with the WHO-toxicity scale.	4 months after the first cycle (each cycle is 21 days)

External Links

•   (NCCN) Clinical Practice Guidelines in Oncology. Breast Cancer, Version 1.2022
•   Guidelines of Chinese Society of Clinical Oncology (CSCO) on Diagnosis and Treatment of Breast Cancer (2020 version)
•   WHO-toxicity scale