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

October 8, 2024 updated by: The Hong Kong Polytechnic University

The Effects of a Nurse-led MHealth Program for Symptom Self-management of Breast Cancer Patients Undergoing Chemotherapy in Shanghai: a Randomized Controlled Pilot Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Ruijin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: mChemotherapy group
The intervention group participants will adopt an app "mChemotherapy" to self-manage their symptoms under nurse-led supervision for six weeks.
Device: mChemotherapy
The intervention is composed of one core intervention "mChemotherapy", one pre-chemotherapy consultation, and two app follow-up visits. mChemotherapy will be specifically utilized to facilitate symptom self-management for intervention group covering chemotherapy for six weeks. The mChemotherapy includes six components: (i) self-monitoring, (ii) alerts, (iii) reminder, (iv) consultation, (v) my prescription, (vi) knowledge base. Intervention group participants will be given an individual username and password to log in to the mChemotherapy platform. The intervention nurses will deliver the intervention and contact patients through this platform.
No Intervention: Control group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Score of the Strategies Used by People to Promote Health (SUPPH) at week 3 (T1) and week 6 (T2)
Time Frame: Data collection will be conducted before chemotherapy (baseline), at week 3 (T1), week 6 (T2)
Strategies Used by People to Promote Health (SUPPH) is a health promotion strategy questionnaire, developed to evaluate the confidence of cancer patients in self-managing their disease, on the basis of expert consultations, patient interviews, and literature research. The original scale has 29 items and uses a 5-point Likert scale, from 1, indicating no confidence to 5, indicating extremely confident. High scores indicate a high level of self-efficacy on the part of the participants. The Chinese version of the SUPPH was adapted by Qian & Yuan and the Cronbach's α coefficient of the total scale is 0.970 . SUPPH will be collected at baseline (week 0), week 3 and at the end of the study (week 6) using self-reported questionnaires handed out through the Breast Health Centre's official WeChat.
Data collection will be conducted before chemotherapy (baseline), at week 3 (T1), week 6 (T2)
Acceptability
Time Frame: Data will be collected at week 6 (T2)
The intervention acceptability and usability will be tested by a self-report questionnaire, the System Usability Scale, after completing the study (week 6).
Data will be collected at week 6 (T2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Score of the Functional Assessment of Cancer Therapy-Breast (FACT-B) at week 3 (T1) and week 6 (T2)
Time Frame: Data collection will be conducted before chemotherapy (baseline), at week 3 (T1), week 6 (T2)
General quality of life has been used as a prominent measurement to reflect the outcome of a treatment. Functional Assessment of Cancer Therapy-Breast (FACT-B) is selected, since it is a HRQoL instrument specific to BC patients. FACT-B is divided into five subscales, namely, physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns. Higher scores indicate a better QOL on the part of the participants. Wan et al. reported that the internal consistency of most domains in the simplified Chinese version of FACT-B ranged from 0.82 to 0.85. FACT-B will be collected before chemotherapy (baseline), week 3 and at the end of the study (week 6) using self-reported questionnaires handed out through the Breast Health Centre's official WeChat.
Data collection will be conducted before chemotherapy (baseline), at week 3 (T1), week 6 (T2)
Change from Score at week 3 (T1) of the Memorial Symptom Assessment Scale-Short Form (MSAS-SF) at week 6 (T2)
Time Frame: Data collection will be conducted at week 3 (T1) and week 6 (T2)
The Memorial Symptom Assessment Scale-Short Form (MSAS-SF) is an instrument that can be used to measure BC patient symptoms of distress. This questionnaire is composed of three dimensions: the Physical Symptom dimension (PHYS), the Psychological Symptom dimension (PSYCH), and a Global Distress Index (GDI). It includes 28 items on distress and frequency in the physical symptom dimension and four items in the psychological symptom dimension during the past week. Higher scores mean more frequency, greater severity and higher distress. The simplified Chinese version of the Memorial Symptom Assessment Scale-Short Form (MSAS-SF-SC) has been found to be reliable, with Cronbach's alpha coefficients for the subscales ranging from 0.782 to 0.874. MSAS-SF will be collected at week 3 and at the end of the study (week 6) using self-reported questionnaires handed out through the Breast Health Centre's official WeChat.
Data collection will be conducted at week 3 (T1) and week 6 (T2)
Healthcare service utilization
Time Frame: Data collection will be conducted at week 3 (T1) and week 6 (T2)
Chemotherapy-induced healthcare utilisation for six weeks will be recorded in the pilot study for analysis. Three types of healthcare utilisation will be collected: patient-initiated hotline calls, unplanned visits to the ambulatory clinic, and unscheduled visits to the emergency department. These records of healthcare service will be obtained from the statistics centre of the study hospital.
Data collection will be conducted at week 3 (T1) and week 6 (T2)
End-user engagement by patients and nurses
Time Frame: From baseline up to week 6 (T2)
Data on an individual's six weeks of usage, including log-in frequency and duration of usage of the whole mChemotherapy program, are tracked in the WeChat statistics module of the background thread. Log-in frequency is recorded as the number of times a participant logged into the app for six weeks. The total duration of usage is recorded as the sum of all times in minutes between logging in and logging out.
From baseline up to week 6 (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ruijin Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nuo Shi, MPH, The Hong Kong Polytechnic University
  • Study Chair: Arkers KC Wong Dr, PhD, The Hong Kong Polytechnic University
  • Study Chair: Frances KY Wong Prof, PhD, The Hong Kong Polytechnic University
  • Study Director: Xiaobin Lai Dr, PhD, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSEARS20210816002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The pilot study outcomes will only be used to publish, with no personal information revealed. All participant names will be replaced with participant codes to ensure confidentiality and anonymity.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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