EVALUATING THE EFFECTIVENESS OF COMMUNITY HEALTH NURSE-LED AND TEXT MESSAGING INTERVENTIONS TO IMPROVE BREAST CANCER SCREENING IN GHANA: A MULTI-ARM RANDOMISED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 828
- 试验地点
- 1
- 主要终点
- Clinical breast examination uptake
研究概览
简要总结
This study aims to implement two interventions to determine the most effective one that can improve Ghanaian women's decision to get their breasts examined by a healthcare professional. The two interventions are (1) a system where community health nurses will be leveraged to educate women on breast cancer screening; (2) a system where women will be sent text messages about breast cancer screening. Both interventions will be carried out over five months. A survey will be conducted before the intervention is introduced. Then, after the sixth month, another survey will be implemented to determine whether there have been changes. Only women who are 25 years or older will be included in the study.
详细描述
Research Design This study will employ a randomised controlled trial (RCT) design. Specifically, a multi-arm parallel RCT design will be used. Participants will be assigned to receive either a CHN-led intervention, a text messaging intervention, or be in the control group. This parallel RCT will be a superiority trial in nature (Spieth et al., 2016). It will seek to compare the two interventions and establish the intervention that is most effective in improving screening uptake, enhancing knowledge, and promoting positive health beliefs. Essentially, participants in the CHN-led and text messaging groups will receive the same information but delivered through distinct media. The baseline for this study will be collected as part of a larger prospective longitudinal study in Ghana, India, and Nepal (ID: SREIC/2025/067).
Description of interventions CHN-led intervention: Participants in this group will engage in structured CHN-led education sessions on breast cancer screening for five months. Each month will focus on a specific theme. The sessions will be facilitated by trained community health nurses who are experienced in health education and culturally competent in working with the study communities. The CHN will receive a brief orientation and training on the study protocol, educational content, and facilitation techniques to ensure consistency in facilitation. This intervention will take the form of bi-weekly sessions that last 60 minutes over five months. These sessions will cover understanding and demystifying breast cancer and its screening (month one), risk factors of breast cancer (month two), suggestive signs and symptoms to prompt early healthcare seeking (month three), costs and benefits of undergoing breast cancer screening (month four), and building confidence and intention to get screened (month five). The intervention will be interactive, incorporating group discussions and culturally tailored educational materials (a take-home pamphlet) to maximise engagement. To ensure engagement, the CHN will be required to monitor attendance, conduct post-session reflections, and do follow-up calls for those who may miss the session. In all five, CHNs will be recruited. Each CHN will serve 5 groups, each consisting of 11 participants.
Text messaging intervention: For this intervention, participants will receive text messages on breast cancer screening for five months. Similar to the CHN-led intervention, the text messaging intervention will cover the following topics: cover understanding and demystifying breast cancer and its screening (month one), risk factors of breast cancer (month two), suggestive signs and symptoms to prompt early healthcare seeking (month three), costs and benefits of undergoing breast cancer screening (month four), and building confidence and intention to get screened (Asare et al., 2024). Informed by the findings of Bonful et al. (2022), text messages will be sent to participants between 6:00am and 8:00pm two times a week - Wednesdays and Saturdays.
Control group: The control group will receive no interventions, but the standard care provided at the community level. This standard of care is the usual community healthcare information that borders on environmental hygiene, healthy eating, exercising, family planning and reproductive health, and motivations to seek prompt healthcare.
Sampling and randomisation procedures Previous studies have found a significantly lower risk of breast cancer among young women (<25 years) (Okyere et al., 2024; Xu & Xu, 2023). Hence, only women aged ≥25 years will be eligible to participate in the study. Prospective participants must be people who will be residing in the Danfa community for the next nine months. Any woman who is below the eligible age or who knows for a fact that they will be unavailable throughout the duration of the study will be excluded. A list of all eligible participants will be drawn from the baseline study that will precede the RCT. With this baseline information, a simple random sampling technique will be used to select participants into the RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must be a female aged 25 years or older
- •Must be resident in the Danfa community
- •Must be someone who can confirm their availability for at least the next eight months after the initiation of the trial
排除标准
- •Females aged <25 years
- •Women who are not resident in the study setting
- •Women who cannot be available for at least the next eight months after the initiation of the trial
结局指标
主要结局
Clinical breast examination uptake
时间窗: Five months after the intervention
The proportion of women who would have had their breasts examined by a health care professional and the proportion of women who would have practiced breast self-examination.
次要结局
- Breast cancer literacy(Five months after the implementation of the intervention.)
- Attitude to breast cancer screening(Five months after the implementation of the intervention.)
