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Clinical Trials/NCT05489354
NCT05489354
Completed
Not Applicable

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

Chinese University of Hong Kong2 sites in 1 country126 target enrollmentSeptember 1, 2022
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Chinese University of Hong Kong
Enrollment
126
Locations
2
Primary Endpoint
Change in self-efficacy
Status
Completed
Last Updated
2 years ago

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 1. 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 2. 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: 1. a significantly higher level of self-efficacy, 2. a significantly higher level of coping, 3. a significantly higher level of quality of life, 4. a significantly lower level of symptom distress, 5. a significantly lower level of anxiety and depression.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
June 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Akingbade Oluwadamilare

Principal Investigator

Chinese University of Hong Kong

Eligibility Criteria

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

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)

Study Sites (2)

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