The Effects of a Nurse-led MHealth Program for Symptom Self-management of Breast Cancer Patients Undergoing Chemotherapy (mChemo)

The Hong Kong Polytechnic University

Status: Completed

Conditions: Breast Cancer; Chemotherapeutic Toxicity

Treatments: Device: mChemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05192525

HSEARS20210816002

Details and patient eligibility

About

Breast cancer (BC) survivors will experience multiple symptoms following chemotherapy. During the pandemic of COVID-19, the closure of clinics and fear of infection lead to BC patients' challenges in self-managing their multiple symptoms in home settings. Mobile health (mHealth), without time and space limitation, plays a positive role in supporting self-management and treatment compliance. However, previous mHealth self-management studies did not report sustained beneficial effects with physician-led supervision. In oncology practice, the nurse-led model of patient self-management for breast cancer has been placed on greater emphasis. Accordingly, an innovative nurse-led supervised mHealth program was designed to support self-management for BC patients undergoing chemotherapy.

This pilot study aims to examine the feasibility and acceptability of a nurse-led mHealth-based self-management program for BC patients receiving chemotherapy, in order to provide evidence for conducting a definitive trial. The feasibility outcomes of the pilot study include subject eligibility rate, recruitment rate, and retention rate. The efficacy outcomes relate to self-efficacy (primary outcome), symptom distress and frequency, as well as health-related quality of life, and healthcare utilisation. The qualitative outcomes encompass patient- and provider-users' perceptions of the app usability and subjects' experiences of engaging in the pilot study.

Full description

This nurse-led mHealth symptom self-management program is composed of one core intervention 'mChemotherapy', one pre-chemotherapy consultation, and two follow-up visits. mChemotherapy will be specifically utilized to facilitate symptom self-management for breast cancer patients covering chemotherapy.

The objectives of the pilot study are: (i) to develop an evidence-based nurse-led mHealth guideline for self-management of chemotherapy-related symptoms; (ii) to determine the usability of a nurse-led mobile application; (iii) to pilot the methodological procedures of the randomized controlled trial; (iv) to determine enrollment rate, the eligibility rate, retention rate, and dropout rate during the preliminary RCT participant recruitment and follow-up process; (v) to preliminarily test the effectiveness of this program on self-efficacy, QoL, symptom distress and symptom frequency, as well as healthcare utilization; (vi) to identify the participants' perceptions and acceptability of the pilot study; (vii) to provide suggestions and implications for a future multicentre large-scale RCT examining the definite effects of nurse-led mHealth self-management guidelines on self-efficacy, QoL, symptom distress and symptom frequency in cancer patients undergoing chemotherapy.

The pilot study aims to examine the following null hypotheses of efficacy outcomes:

The BC patients in the mHealth group will demonstrate no difference in self-efficacy, quality of life, symptom distress and symptom frequency, as well as healthcare utilization after completing the chemotherapy at week 3 and week 6 when compared to the BC patients in the control group.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• People who are 18 years or above
• Newly diagnosed with breast cancer
• Commencing chemotherapy and being prescribed with four cycles of a chemotherapy regimen
• Mobile phone and WeChat® users (a mobile application of Shenzhen city's Tencent computer system Co. Ltd.)
• Wi-Fi or 4G network users
• Able to read and write Chinese

Exclusion criteria

• People who are pregnant
• Have been diagnosed with terminal-stage breast cancer (i.e., stage IV)
• Have a history of chemotherapy
• Have been prescribed with targeted therapy within three weeks of completing the chemotherapy
• Have documented mental disorders
• Have already engaged in other mHealth studies

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups

mChemotherapy group

Experimental group

Description:

The intervention group participants will adopt an app "mChemotherapy" to self-manage their symptoms under nurse-led supervision for six weeks.

Treatment:

Device: mChemotherapy

Control group

No Intervention group

Description:

Participants in control group will receive routine care, with no use of mChemotherapy during six weeks. Routine care is composed of a pre-chemotherapy visit and two follow-up visits. Through the Official WeChat platform, the patients in control group will be informed about the chemotherapy regimen, and chemotherapy-related symptoms and how to deal with them, during the pre-chemotherapy visit. The control group will have two scheduled visits by telephone with the follow-up nurse. Patients will be given a phone number for consulting the follow-up nurse should they have questions related to their symptoms, or concerns related to the chemotherapy. Patients in the control group cannot access the "mChemotherapy" until they have completed the pilot study.