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

NCT05258461 | Unknown DMC

• 1 other identifier: Smart
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Cancer

Keywords

Application; Adverse Event; Quality of Life; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence and severity of 12 common adverse events

  4 months after the first cycle (each cycle is 21 days)

Other Outcomes (3)

• Login times

  Documented automatically by the application every two weeks

• Average time spent on the application

  Documented automatically by the application every two weeks

• Questions addressed on the Q&A platform

  Documented automatically by the application every two weeks

Study Arms (2)

The intervention group

EXPERIMENTAL

The intervention group will receive conventional adverse event management and have access to the smartphone app during chemotherapy.

Other: use of a smartphone app for adverse event management; Other: conventional adverse event management

The control group

ACTIVE COMPARATOR

The control group will receive conventional adverse event management during chemotherapy. Chemotherapy-related adverse events in the control group will be managed with symptomatic treatment, dietary and lifestyle prescription according to the doctors' clinical experience.

Other: conventional adverse event management

Interventions

use of a smartphone app for adverse event management OTHER

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.

The intervention group

conventional adverse event management OTHER

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.

The control group; The intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pathological diagnosis of invasive breast cancer
• breast surgery within the past 2-8 weeks
• adult female
• must be able to use mobile phones
• speak and write Chinese fluently to sign the informed consent

You may not qualify if:

• severe comorbidity that interferes with outcome evaluation
• insufficient Chinese language skills
• inability to use mobile phones
• cognitive disability to give informed consent

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Related 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.

  PMID: 21513533 BACKGROUND

• 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.

  PMID: 18653703 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yan Li, Doctor

  Department of Breast Surgery, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Yan Li, Doctor

CONTACT

+86 17600352101; liyan0551@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 28, 2022
• Study Start: March 7, 2022
• Primary Completion: October 7, 2022
• Study Completion: December 7, 2022
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share