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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 126
- Locations
- 2
- Primary Endpoint
- Change in self-efficacy
Study Overview
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.
Detailed Description
Aim The study aims to develop and implement a culturally adapted mHealth psychoeducational intervention (mPEI) for Nigerian women diagnosed with breast cancer receiving chemotherapy.
Objectives
- To evaluate the effectiveness of the programme on self-efficacy (primary outcome), coping, symptom distress, anxiety, depression, and quality of life (secondary outcomes) among women with breast cancer receiving chemotherapy
- To explore the participants' experiences and feelings towards the intervention.
Hypothesis
It is hypothesised that participants who receive the mPEI program, when compared with the control group at baseline and immediately after the intervention, will demonstrate:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
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
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Include females who are:
- •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.
Exclusion Criteria
- •Include females:
- •with a concurrent physical or mental illness (as these might act as a confounder)
- •cognitively impaired
Arms & Interventions
mHealth psychoeducational intervention
The intervention group will receive six weeks mHealth psychoeducational intervention (mPEI) delivered through a mobile application.
Intervention: mHealth psychoeducational intervention (Other)
Control Group
No psychoeducational intervention will be given.
Outcomes
Primary Outcomes
Change in self-efficacy
Time Frame: Pre-intervention and immediately after the six weeks intervention
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.
Secondary Outcomes
- Change in Depression(Pre-intervention and immediately after the six weeks intervention)
- Change in Coping(Pre-intervention and immediately after the six weeks intervention)
- Change in Symptom Distress(Pre-intervention and immediately after the six weeks intervention)
- Change in Anxiety(Pre-intervention and immediately after the six weeks intervention)
- Change in Quality of Life(Pre-intervention and immediately after the six weeks intervention)
Investigators
Akingbade Oluwadamilare
Principal Investigator
Chinese University of Hong Kong