mHealth Usage Among Nigeria Women Diagnosed With Breast Cancer Receiving Chemotherapy
Effect of a mHealth Psycho-educational Intervention (mPEI) on Self-efficacy, Coping, and Psychological Distress Among Women Receiving Chemotherapy for Breast Cancer in Nigeria: A Randomised Controlled Trial
1 other identifier
interventional
126
1 country
2
Brief Summary
The research is studying the effect of a mHealth psychoeducational intervention on self-efficacy, coping and psychological distress of Nigerian women diagnosed with breast cancer receiving chemotherapy The study is a two-arm assessor-blinded randomised controlled trial which will be conducted in two University Teaching Hospitals in Nigeria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Sep 2022
Shorter than P25 for not_applicable breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2022
CompletedFirst Posted
Study publicly available on registry
August 5, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedAugust 1, 2023
July 1, 2023
7 months
August 3, 2022
July 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in self-efficacy
Self-efficacy for coping with cancer will be measured with the Cancer Behaviour Inventory-Brief Version (CBI-B). This is a 12-item instrument measuring confidence of individuals in performing activities that show how well they are coping with the demands of cancer and their treatment. Each item will be scored on a nine-point Likert scale with '1' meaning 'not at all confident' and '9' meaning 'totally confident'. The lowest score is 12 and the highest score is 108. Higher scores indicate greater self-efficacy in coping.
Pre-intervention and immediately after the six weeks intervention
Secondary Outcomes (5)
Change in Coping
Pre-intervention and immediately after the six weeks intervention
Change in Anxiety
Pre-intervention and immediately after the six weeks intervention
Change in Depression
Pre-intervention and immediately after the six weeks intervention
Change in Symptom Distress
Pre-intervention and immediately after the six weeks intervention
Change in Quality of Life
Pre-intervention and immediately after the six weeks intervention
Study Arms (2)
mHealth psychoeducational intervention
EXPERIMENTALThe intervention group will receive six weeks mHealth psychoeducational intervention (mPEI) delivered through a mobile application.
Control Group
NO INTERVENTIONNo psychoeducational intervention will be given.
Interventions
The mPEI program will be delivered through a mobile application (app). The app has five components which include: Breast cancer education, coping skills training, discussion forum, nurse-led consultation, and psychological support. Breast cancer education and coping skills training will be conducted by the principal investigator for 30 minutes per week for six weeks and will be delivered via text, audio and video on the mobile app. Group discussion will be moderated by the principal investigator in a text format for 30 minutes per week. Nurse-led consultation and psychological support will be provided by the oncology nurse on the research team through a 15-20-minute call in the first week, third week and fifth week.
Eligibility Criteria
You may qualify if:
- newly diagnosed with breast cancer within the recent three months
- currently receiving chemotherapy,
- have access to a smartphone and internet,
- are able to read and write in English,
- are cognitively capable of completing the questionnaires,
- consent to join the study.
You may not qualify if:
- with a concurrent physical or mental illness (as these might act as a confounder)
- cognitively impaired
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Lagos State University Teaching Hospital
Lagos, Nigeria
Lagos University Teaching Hospital
Lagos, Nigeria
Related Publications (1)
Akingbade O, Hong KY, Ayo OS, Alade AS, Lawal MA, Somoye IE, Adediran V, Sado O, Chow KM. Development and feasibility of an mHealth intervention for psychoeducational support of Nigerian women diagnosed with breast cancer undergoing chemotherapy: A pilot randomized controlled trial. PLoS One. 2024 Nov 25;19(11):e0314365. doi: 10.1371/journal.pone.0314365. eCollection 2024.
PMID: 39585879DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ka Ming Chow, DN
The Nethersole School of Nursing, Chinese University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The research assistants who assess outcome data, data entry and analysis will be blinded to avoid the risk of assessor bias. The assistants will not participate in any other stage of implementing the program
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 3, 2022
First Posted
August 5, 2022
Study Start
September 1, 2022
Primary Completion
March 30, 2023
Study Completion
June 30, 2023
Last Updated
August 1, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share