Clinical trial NCT05192525: The Effects of a Nurse-led MHealth Program for Symptom Self-management of Breast Cancer Patients Undergoing Chemotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Chemotherapeutic Toxicity
Keywords: nurse-led
mHealth
self-management
breast cancer
chemotherapy
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
First posted: 2022-01-14
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Score of the Strategies Used by People to Promote Health (SUPPH) at week 3 (T1) and week 6 (T2)
timeFrame: Data collection will be conducted before chemotherapy (baseline), at week 3 (T1), week 6 (T2)
measure: Acceptability
timeFrame: Data will be collected at week 6 (T2)
Secondary outcomes:
measure: Change from Baseline Score of the Functional Assessment of Cancer Therapy-Breast (FACT-B) at week 3 (T1) and week 6 (T2)
timeFrame: Data collection will be conducted before chemotherapy (baseline), at week 3 (T1), week 6 (T2)
measure: Change from Score at week 3 (T1) of the Memorial Symptom Assessment Scale-Short Form (MSAS-SF) at week 6 (T2)
timeFrame: Data collection will be conducted at week 3 (T1) and week 6 (T2)
measure: Healthcare service utilization
timeFrame: Data collection will be conducted at week 3 (T1) and week 6 (T2)
measure: End-user engagement by patients and nurses
timeFrame: From baseline up to week 6 (T2)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Nuo Shi, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hong Kong Polytechnic University
name: Arkers KC Wong Dr, PhD
role: STUDY_CHAIR
affiliation: The Hong Kong Polytechnic University
name: Frances KY Wong Prof, PhD
role: STUDY_CHAIR
affiliation: Fudan University
name: Xiaobin Lai Dr, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.