Clinical trial NCT05489354: mHealth Usage Among Nigeria Women Diagnosed With Breast Cancer Receiving Chemotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Chemotherapy
Women
Psychoeducation
mHealth
Nursing
Psychological issues
Nigeria
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria: Include females who are:

1. newly diagnosed with breast cancer within the recent three months
2. currently receiving chemotherapy,
3. have access to a smartphone and internet,
4. are able to read and write in English,
5. are cognitively capable of completing the questionnaires,
6. consent to join the study.

Exclusion Criteria: Include females:

1. with a concurrent physical or mental illness (as these might act as a confounder)
2. cognitively impaired

Primary outcomes:
measure: Change in self-efficacy
timeFrame: Pre-intervention and immediately after the six weeks intervention
Secondary outcomes:
measure: Change in Coping
timeFrame: Pre-intervention and immediately after the six weeks intervention
measure: Change in Anxiety
timeFrame: Pre-intervention and immediately after the six weeks intervention
measure: Change in Depression
timeFrame: Pre-intervention and immediately after the six weeks intervention
measure: Change in Symptom Distress
timeFrame: Pre-intervention and immediately after the six weeks intervention
measure: Change in Quality of Life
timeFrame: Pre-intervention and immediately after the six weeks intervention
Other outcomes:
Locations:
city: Lagos
country: Nigeria
facility: Lagos State University Teaching Hospital
city: Lagos
country: Nigeria
facility: Lagos University Teaching Hospital
Study officials:
affiliation: The Nethersole School of Nursing, Chinese University of Hong Kong
name: Ka Ming Chow, DN
role: STUDY_CHAIR
References: