An interventional study of mHealth psychoeducational intervention in Breast Cancer, sponsored by Chinese University of Hong Kong. Completed at 2 sites in Nigeria. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Supportive care
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.
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
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:
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 126 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
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Inclusion Criteria: Include females who are:
Exclusion Criteria: Include females:
The intervention group will receive six weeks mHealth psychoeducational intervention (mPEI) delivered through a mobile application.
Other: mHealth psychoeducational intervention
No psychoeducational intervention will be given.
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.
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.
Time frame: Pre-intervention and immediately after the six weeks intervention
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.
Time frame: Pre-intervention and immediately after the six weeks intervention
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.
Time frame: Pre-intervention and immediately after the six weeks intervention
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.
Time frame: Pre-intervention and immediately after the six weeks intervention
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.
Time frame: Pre-intervention and immediately after the six weeks intervention
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.
Time frame: Pre-intervention and immediately after the six weeks intervention
Plan to share: No
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong