Ignite Creation Date:
2024-05-06 @ 5:55 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05489354
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2022-08-03
Brief Title:
mHealth Usage Among Nigeria Women Diagnosed With Breast Cancer Receiving Chemotherapy
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None