mHealth Usage Among Nigeria Women Diagnosed With Breast Cancer Receiving Chemotherapy
NCT ID: NCT05489354
Last Updated: 2023-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
126 participants
INTERVENTIONAL
2022-09-01
2023-06-30
Brief Summary
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The study is a two-arm assessor-blinded randomised controlled trial which will be conducted in two University Teaching Hospitals in Nigeria.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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mHealth psychoeducational intervention
The intervention group will receive six weeks mHealth psychoeducational intervention (mPEI) delivered through a mobile application.
mHealth psychoeducational intervention
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.
Control Group
No psychoeducational intervention will be given.
No interventions assigned to this group
Interventions
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mHealth psychoeducational intervention
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
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Inclusion Criteria
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
2. cognitively impaired
18 Years
70 Years
FEMALE
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Akingbade Oluwadamilare
Principal Investigator
Principal Investigators
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Ka Ming Chow, DN
Role: STUDY_CHAIR
The Nethersole School of Nursing, Chinese University of Hong Kong
Locations
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Lagos State University Teaching Hospital
Lagos, , Nigeria
Lagos University Teaching Hospital
Lagos, , Nigeria
Countries
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References
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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.
Other Identifiers
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2021.693
Identifier Type: -
Identifier Source: org_study_id
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