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

NCT05192525 | Completed

• 1 other identifier: HSEARS20210816002
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Chemotherapeutic Toxicity

Keywords

nurse-led; mHealth; self-management; breast cancer; chemotherapy

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Score of the Strategies Used by People to Promote Health (SUPPH) at week 3 (T1) and 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

  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 Outcomes (4)

• Change from Baseline Score of the Functional Assessment of Cancer Therapy-Breast (FACT-B) at week 3 (T1) and week 6 (T2)

  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)

  Data collection will be conducted at week 3 (T1) and week 6 (T2)

• Healthcare service utilization

  Data collection will be conducted at week 3 (T1) and week 6 (T2)

• End-user engagement by patients and nurses

  From baseline up to week 6 (T2)

Study Arms (2)

mChemotherapy group

EXPERIMENTAL

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

Device: mChemotherapy

Control group

NO INTERVENTION

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.

Interventions

mChemotherapy DEVICE

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.

mChemotherapy group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Ruijin Hospital: collaborator

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Location

Related Publications (9)

• Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.

  PMID: 847061 BACKGROUND

• 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.

  PMID: 9060536 BACKGROUND

• Chang VT, Hwang SS, Feuerman M, Kasimis BS, Thaler HT. The memorial symptom assessment scale short form (MSAS-SF). Cancer. 2000 Sep 1;89(5):1162-71. doi: 10.1002/1097-0142(20000901)89:53.0.co;2-y.

  PMID: 10964347 BACKGROUND

• Fu L, Hu Y, Lu Z, Zhou Y, Zhang X, Chang VT, Yang Y, Wang Y. Validation of the Simplified Chinese Version of the Memorial Symptom Assessment Scale-Short Form Among Cancer Patients. J Pain Symptom Manage. 2018 Jul;56(1):113-121. doi: 10.1016/j.jpainsymman.2018.03.024. Epub 2018 Apr 5.

  PMID: 29627566 BACKGROUND

• Lev EL, Owen SV. A measure of self-care self-efficacy. Res Nurs Health. 1996 Oct;19(5):421-9. doi: 10.1002/(SICI)1098-240X(199610)19:53.0.CO;2-S.

  PMID: 8848626 BACKGROUND

• Oliveira IS, da Cunha Menezes Costa L, Fagundes FR, Cabral CM. Evaluation of cross-cultural adaptation and measurement properties of breast cancer-specific quality-of-life questionnaires: a systematic review. Qual Life Res. 2015 May;24(5):1179-95. doi: 10.1007/s11136-014-0840-3. Epub 2014 Nov 13.

  PMID: 25391488 BACKGROUND

• Yuan C, Qian H, Wang J, Lev EL, Yuan A, Hinds PS. Factorial structure of a scale: Strategies Used by People to Promote Health--Chinese version. Cancer Nurs. 2015 Jan-Feb;38(1):E13-20. doi: 10.1097/NCC.0000000000000151.

  PMID: 24945261 BACKGROUND

• 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.

  PMID: 17377841 BACKGROUND

• Shi N, Ching Wong AK, Yuet Wong FK, Zhang N, Zhu W, Shen K, Lai X, Jin Y, Gu C, Nie L, Dong X. Feasibility of a mobile health app-based self-management program for Chinese patients with breast cancer receiving chemotherapy: A randomized controlled pilot study. Digit Health. 2024 Feb 25;10:20552076241231560. doi: 10.1177/20552076241231560. eCollection 2024 Jan-Dec.

  PMID: 38410790 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Nuo Shi, MPH

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

• Arkers KC Wong Dr, PhD

  The Hong Kong Polytechnic University

  STUDY CHAIR

• Frances KY Wong Prof, PhD

  The Hong Kong Polytechnic University

  STUDY CHAIR

• Xiaobin Lai Dr, PhD

  Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The control group will be blinded to the allocation results and intervention. The experimental group will be informed the procedure of intervention. Before participants sign the consent form, the results of the group random assignments will be put in opaque envelopes handed out by a nurse, who will not be involved in the allocation and intervention, to participants during their pre-chemotherapy consultation. The data collectors will be blinded to the allocation results. The nurses and research assistants arranging the process of screening participants for eligibility will not be in charge of the group allocations and intervention. The nurses who will be responsible for the control group with routine care will not be involved in the intervention or the screening and group allocations.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be a double-blinded, randomized, controlled trial, including one intervention group (group A) and one control group (group B). The control group will be treated with routine care only. The intervention group participants will receive one core intervention "mChemotherapy", one pre-chemotherapy consultation, and two scheduled visits. "mChemotherapy" is built on the official WeChat platform of the Ruijin Breast Health Centre and includes six components: (i) self-monitoring, (ii) alerts, (iii) reminder, (iv) consultation, (v) my prescription, (vi) knowledge base. The intervention group participants will take part in an mChemotherapy program for six weeks. The intervention nurses will deliver the intervention and contact patients through this platform.

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 14, 2022
• Study Start: May 16, 2022
• Primary Completion: August 23, 2023
• Study Completion: August 23, 2023
• Last Updated: October 10, 2024

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)