[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650252":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":31,"studyPopulation":21,"armGroups":32,"interventions":50,"overallOfficials":63,"centralContacts":70,"locations":76,"responsibleParty":96,"collaborators":21,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":21,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":21,"enrollmentInfo":107,"targetDuration":21,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":121,"whyStopped":21,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"University of Huddersfield","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical breast examination uptake","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.","Five months after the intervention",[14,18],{"measure":15,"description":16,"timeFrame":17},"Breast cancer literacy","The proportion of women who are knowledgeable of breast cancer risk factors, and the suggestive signs and symptoms of breast cancer.","Five months after the implementation of the intervention.",{"measure":19,"description":20,"timeFrame":17},"Attitude to breast cancer screening","The proportion of women with a positive attitude towards breast cancer screening.",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"RANDOMIZED","PARALLEL","SCREENING",{"masking":27,"maskingDescription":21,"whoMasked":28},"DOUBLE",[29,30],"PARTICIPANT","OUTCOMES_ASSESSOR","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\u002F2025\u002F067).\n\nDescription 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.\n\nText 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.\n\nControl 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.\n\nSampling and randomisation procedures Previous studies have found a significantly lower risk of breast cancer among young women (\\\u003C25 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.\n\nTo ensure balance across groups and minimise confounding, a priori stratification will be employed before randomisation. Participants will be stratified by age (≤50 years vs. \\>50 years) and screening history at baseline (i.e., ever undergone breast examination or no breast examination). After stratification, block randomisation will be used to assign participants to one of the three study arms in a 1:1:1 ratio. This technique will be adopted to guarantee that the number of participants in each stratum remains balanced throughout the study. This will be achieved by listing all participants and applying Microsoft Excel's random number generator to assign individuals to either arm of the study.\n\nA study by Okyere et al. (2024) estimates a breast cancer screening prevalence of 18.39%. This study posits a 20% increase in screening uptake through the interventions. Therefore, with a power of 80% and design effect of 1.2, the sample size is estimated as:\n\nWhere:\n\n* Zα is the Z-value for the significance level (for α=0.05, one-tailed: Zα=1.645),\n* Zβ is the Z-value for the power (for 80% power, Zβ=0.84),\n* p0 is the baseline proportion (control arm),\n* p1 is the intervention arm proportion.\n\nAdjusted sample size for design effect (effect=1.2):\n\nFinal sample size adjusted for non-response (rate=5%):\n\nTotal sample size for three arms:\n\nSubstituting the figures, the total sample size will be 828 (i.e., 276 participants per arm).\n\nData collection procedures Before the RCT, a baseline survey will be conducted. Three research assistants will be recruited and trained to assist with the collection of data. The research assistants will be people with at least a bachelor's degree in public health or nursing and have at least 12 months of experience conducting public health surveys. They will undertake a one-week intensive training that will cover issues of ethical responsibility, the research methodology, interrogation of the questionnaire, and some role plays.\n\nThe baseline survey will collect information about the socio-demographic characteristics of the participants (e.g., age in completed years, highest level of education attained, marital status, employment status, religion, health insurance coverage, and exposure to media), risk factors (i.e., family history, smoking status, alcohol consumption, etc.), and reproductive health characteristics (e.g., age at menarche, menopausal status, age at first sex, use of oral contraceptives, etc.). And so, the baseline study will assess the state of depression and anxiety among participants using the Patient Health Questionnaire (PHQ-9) and generalised anxiety disorder (GAD-7) scale, respectively (Shevlin et al., 2022). Additionally, baseline assessment of the participants' attitudes to screening will be done using the attitude to cancer screening (ASCS-15) scale (Sarkhani et al., 2023). Each participant recruited into the baseline (pre-intervention survey) will be assigned a unique code that will be used to follow up on them after the implementation of the intervention.\n\nFive months after the implementation of the intervention, a follow-up data collection will be conducted to measure key outcomes of interest. These include the proportion of women who would have the intention to screen post-intervention, the proportion of women who would have been screened post-intervention, the proportion of women with good attitudes to breast cancer screening post-intervention, and the breast cancer literacy rate post-intervention. Participants will be contacted in-person to minimise non-response and loss to follow-up. The questionnaire will be designed and administered using REDCAP (Harris et al., 2019). The data collection will be stored on my student OneDrive, which will be accessible only to my supervisors.\n\nData analyses All statistical analyses will be performed in STATA version 18 (StataCorp, College Station, TX) and Rv4.3.2. The study will adhere to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Descriptive analyses will be performed to compare screening uptake, attitude to screening, and screening intentions at baseline and post-intervention. Pearson's chi-square test will be used to assess whether the observed prevalence differs significantly. To mitigate attrition bias, the study will implement a rigorous intention-to-treat (ITT) approach, wherein all randomised participants will be analysed within their originally assigned groups, irrespective of adherence to the intervention or dropout status. This analytical strategy preserves the benefits of randomisation, provides an unbiased estimate of the intervention's effectiveness, and enhances the generalisability of the findings (Spieth et al., 2016)",[33,39,44],{"label":34,"type":35,"description":36,"interventionNames":37},"Arm 1","EXPERIMENTAL","Participants assigned to this arm will receive a structured community health nurse (CHN)-led breast cancer screening education programme delivered over five months. Trained CHNs will facilitate ten biweekly 60 minute interactive sessions, with each month focusing on a specific theme: understanding breast cancer and screening, risk factors, signs and symptoms, costs and benefits of screening, and building confidence and intention to undergo screening. CHNs will receive standardized training on the study protocol, educational content, and facilitation methods to ensure intervention fidelity. Sessions will incorporate group discussions and culturally appropriate take-home pamphlets to enhance engagement. Attendance will be monitored, post-session reflections conducted, and follow-up phone calls made to participants who miss sessions. Five CHNs will each facilitate five groups of eleven participants.",[38],"Other: Community Health Nurse-Led Breast Cancer Screening Education",{"label":40,"type":35,"description":41,"interventionNames":42},"Arm 2","Participants assigned to this arm will receive a structured breast cancer screening text messaging programme over five months. Messages will be delivered twice weekly on Wednesdays and Saturdays between 6:00 a.m. and 8:00 p.m. The intervention will cover the same monthly themes as the CHN-led arm to ensure consistency: understanding breast cancer and screening, risk factors, signs and symptoms, costs and benefits of screening, and building confidence and intention to undergo screening. Message content will be evidence-informed and culturally appropriate, drawing on established breast cancer education materials and previous intervention studies. The timing and frequency of message delivery are based on evidence indicating that twice-weekly messaging within these hours enhances participant engagement and message uptake",[43],"Other: Text Messaging Breast Cancer Screening Educational Intervention",{"label":45,"type":46,"description":47,"interventionNames":48},"Arm 3","PLACEBO_COMPARATOR","Participants assigned to the control arm will receive the standard community-based healthcare routinely provided through existing primary healthcare services, with no additional breast cancer screening intervention. Standard care consists of general health education delivered by community health workers and focuses on topics such as environmental hygiene, healthy eating, physical activity, family planning, reproductive health, and the importance of seeking timely healthcare. No structured breast cancer education or text messaging will be provided during the study period. This group will serve as the comparator for evaluating the effectiveness of the CHN-led and text messaging interventions.",[49],"Other: Control Arm - standard of care",[51,55,59],{"type":6,"name":52,"description":53,"armGroupLabels":54,"otherNames":21},"Community Health Nurse-Led Breast Cancer Screening Education","The Community Health Nurse-led intervention differs from conventional health education programmes by using trained community health nurses who are embedded within the local healthcare system to deliver structured, interactive, and culturally responsive breast cancer screening education. Unlike one-time awareness campaigns, this intervention provides repeated biweekly sessions over five months, allowing progressive learning, reinforcement of key messages, and opportunities to address participant concerns and misconceptions.",[34],{"type":6,"name":56,"description":57,"armGroupLabels":58,"otherNames":21},"Text Messaging Breast Cancer Screening Educational Intervention","The text messaging intervention is distinguished by its use of a structured, evidence-informed mobile health approach to deliver breast cancer screening information directly to participants' mobile phones. Unlike generic health reminder messages, the intervention follows the same thematic structure as the CHN-led programme, ensuring delivery of comprehensive breast cancer screening education rather than isolated screening prompts.",[40],{"type":6,"name":60,"description":61,"armGroupLabels":62,"otherNames":21},"Control Arm - standard of care","The control group will receive standard community-level healthcare information routinely provided through existing primary healthcare services and will not receive any additional breast cancer screening-specific education, text messages, or structured intervention activities during the study period. This distinguishes the control condition from the intervention groups by maintaining usual care while allowing evaluation of the added effect of community health nurse-led education and text messaging interventions.",[45],[64,68],{"name":65,"affiliation":66,"role":67},"Padam Simkhada, PhD","University of Chester","STUDY_CHAIR",{"name":69,"affiliation":5,"role":67},"Bibha Simkhada, PhD",[71],{"name":72,"role":73,"phone":74,"phoneExt":21,"email":75},"Joshua Okyere, MPhil","CONTACT","+233249004634","joshua.okyere@hud.ac.uk",[77],{"facility":78,"status":21,"city":79,"state":80,"zip":21,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Danfa Community","Accra","Greater Accra Region","Ghana","GH",{"type":84,"coordinates":85},"Point",[86,87],-0.1969,5.55602,{"lat":87,"lon":86},[90,94],{"name":91,"role":73,"phone":92,"phoneExt":21,"email":93},"Alfred E Yawson, PhD","+233244662711","aeyawson@ug.edu.gh",{"name":72,"role":95,"phone":21,"phoneExt":21,"email":21},"PRINCIPAL_INVESTIGATOR",{"type":97,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100650252","evaluating-interventions-for-breast-cancer-screening-in-ghana-100650252",false,"NCT07745517","Evaluating Interventions for Breast Cancer Screening in Ghana","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","Inclusion Criteria:\n\n* Must be a female aged 25 years or older\n* Must be resident in the Danfa community\n* Must be someone who can confirm their availability for at least the next eight months after the initiation of the trial\n\nExclusion Criteria:\n\n* Males\n* Females aged \\\u003C25 years\n* Women who are not resident in the study setting\n* Women who cannot be available for at least the next eight months after the initiation of the trial","FEMALE","25 Years",{"count":108,"type":109},828,"ESTIMATED","INTERVENTIONAL",[112],"NA","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.",[115],"Breast Cancer Screening",[117,118,119,120],"Breast cancer","Screening","Literacy","Experimental Studies","NOT_YET_RECRUITING","2026-07-29",{"date":124,"type":125},"2026-08-04","ACTUAL",{"date":127,"type":109},"2026-10-01",{"date":129,"type":109},"2027-11-30",{"name":5,"class":6},1]