AzTrials
AzTrials

Breast CancerNCT05489354

mHealth Usage Among Nigeria Women Diagnosed With Breast Cancer Receiving Chemotherapy

A study testing mHealth psychoeducational intervention in people with Breast Cancer, run by Chinese University of Hong Kong at 2 sites in Nigeria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
mHealth psychoeducational intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
2 sitesNigeria
Study dates
1 Sep 2022to 30 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Nigeria2 sites

  • Lagos State University Teaching Hospital

    Lagos

  • Lagos University Teaching Hospital

    Lagos

Other trials in Nigeria

About this study

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

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.

Read the 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.
Conditions
Breast Cancer
Being tested
mHealth psychoeducational intervention
Keywords
Chemotherapy, Women, Psychoeducation, mHealth, Nursing, Psychological issues, Nigeria
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mHealth psychoeducational interventionOther

    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.

Study groups in NCT05489354
Study groupRoleWhat they receive
mHealth psychoeducational interventionExperimentalThe intervention group will receive six weeks mHealth psychoeducational intervention (mPEI) delivered through a mobile application.
Receives: Other: mHealth psychoeducational intervention
Control GroupNo interventionNo psychoeducational intervention will be given.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Pre-intervention and immediately after the six weeks intervention

Secondary outcomes (5)

  1. Change in Coping

    Coping will be assessed through Brief Cope Inventory. This is a 28-item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. Respondents rate items on a 4-point Likert scale, ranging from 1- "I haven't been doing this at all" to 4- "I have been doing this a lot". There are 14 scales in the Brief Cope, with each measuring a specific coping strategy. Each of the 14 scales is comprised of 2 items; total scores on each scale range from 2 (minimum) to 8 (maximum). Higher scores indicate increased utilization of that specific coping strategy. Total scores on each of the scales are calculated by summing the appropriate items for each scale. No items are reverse scored. High scores are indicative of psychological strength, grit, a practical approach to problem-solving and is predictive of positive outcomes.

    Measured: Pre-intervention and immediately after the six weeks intervention

  2. Change in Anxiety

    Anxiety will be assessed with the Hospital Anxiety and Depression Scale (HADS). HADS comprises anxiety and depression subscales with seven items per subscale. A total score of 0-7 is normal, 8-10 is borderline abnormal and 11-21 is abnormal.

    Measured: Pre-intervention and immediately after the six weeks intervention

  3. Change in Depression

    Depression will be assessed with the Hospital Anxiety and Depression Scale (HADS). HADS comprises anxiety and depression subscales with seven items per subscale. A total score of 0-7 is normal, 8-10 is borderline abnormal and 11-21 is abnormal.

    Measured: Pre-intervention and immediately after the six weeks intervention

  4. Change in Symptom Distress

    Symptom distress will be measured with the Monroe Dunaway (M. D.) Anderson Symptom Inventory (MDASI) which comprises 13 items to measure symptom severity and six items to measure the rate of interference of the symptoms with patient's activities of daily living. The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 NRS, with 0 being "not present" and 10 being "as bad as you can imagine." For symptom severity, there are 13 items, the highest score is 130 and the lowest is 13. Higher scores indicate higher degree of symptom severity. For symptom interference, there are six items. The highest score is 60 and the lowest score is 6. Higher scores indicate higher degree of interference of symptoms with activities of daily living.

    Measured: Pre-intervention and immediately after the six weeks intervention

  5. Change in Quality of Life

    Quality of life will be assessed using the Functional Assessment of Cancer Treatment-B (FACT-B). This instrument contains 37-items for measuring five domains of health-related quality of life in BC patients on a 5-point Likert scale. The total score for the five domains ranges from 0-148 with higher scores indicating better quality of life.

    Measured: Pre-intervention and immediately after the six weeks intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2022
  2. Study start1 Sep 2022
  3. Primary completion30 Mar 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05489354
Sponsor's protocol ID
2021.693
Status last verified
Jul 2023
First submitted
3 Aug 2022
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39585879

Questions about this trial

What is this clinical trial studying?

A study testing mHealth psychoeducational intervention in people with Breast Cancer, run by Chinese University of Hong Kong at 2 sites in Nigeria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in self-efficacy (time frame: Pre-intervention and immediately after the six weeks intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05489354, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in