NCT07745517

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
828

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

1.2 years

First QC Date

July 29, 2026

Last Update Submit

July 29, 2026

Conditions

Keywords

Breast cancerScreeningLiteracyExperimental Studies

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Breast cancer literacy

    Five months after the implementation of the intervention.

  • Attitude to breast cancer screening

    Five months after the implementation of the intervention.

Study Arms (3)

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.

Other: Community Health Nurse-Led Breast Cancer Screening Education

Arm 2

EXPERIMENTAL

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

Other: Text Messaging Breast Cancer Screening Educational Intervention

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.

Other: Control Arm - standard of care

Interventions

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.

Arm 3

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.

Arm 1

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.

Arm 2

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Males
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danfa Community

Accra, Greater Accra Region, Ghana

Location

Related Publications (8)

  • Xu H, Xu B. Breast cancer: Epidemiology, risk factors and screening. Chin J Cancer Res. 2023 Dec 30;35(6):565-583. doi: 10.21147/j.issn.1000-9604.2023.06.02.

    PMID: 38204449BACKGROUND
  • Spieth PM, Kubasch AS, Penzlin AI, Illigens BM, Barlinn K, Siepmann T. Randomized controlled trials - a matter of design. Neuropsychiatr Dis Treat. 2016 Jun 10;12:1341-9. doi: 10.2147/NDT.S101938. eCollection 2016.

    PMID: 27354804BACKGROUND
  • Shevlin M, Butter S, McBride O, Murphy J, Gibson-Miller J, Hartman TK, Levita L, Mason L, Martinez AP, McKay R, Stocks TV, Bennett KM, Hyland P, Vallieres F, Valiente C, Vazquez C, Contreras A, Peinado V, Trucharte A, Bertamini M, Panzeri A, Bruno G, Granziol U, Mignemi G, Spoto A, Vidotto G, Bentall RP. Measurement invariance of the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder scale (GAD-7) across four European countries during the COVID-19 pandemic. BMC Psychiatry. 2022 Mar 1;22(1):154. doi: 10.1186/s12888-022-03787-5.

    PMID: 35232409BACKGROUND
  • Sarkhani N, Negarandeh R, Heshmatian ME. Investigating the psychometric properties of the Persian version of the attitude scale for cancer screening. BMC Public Health. 2023 Oct 23;23(1):2068. doi: 10.1186/s12889-023-16981-1.

    PMID: 37872519BACKGROUND
  • Okyere J, Ayebeng C, Dickson KS. Clicks and checks: investigating the association between internet usage frequency and women's uptake of clinical breast examination in Ghana. BMC Health Serv Res. 2024 Sep 27;24(1):1113. doi: 10.1186/s12913-024-11576-x.

    PMID: 39334073BACKGROUND
  • Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.

    PMID: 31078660BACKGROUND
  • Bonful HA, Addo-Lartey AA, Sefenu RS, Nwameme A, Abagre TA, Awua AK, Adu-Aryee NA, Dedey F, Adanu RMK, Okuyemi KS. Developing a culturally tailored short message service (SMS) intervention for improving the uptake of cervical cancer screening among Ghanaian women in urban communities. BMC Womens Health. 2022 May 10;22(1):154. doi: 10.1186/s12905-022-01719-9.

    PMID: 35538476BACKGROUND
  • Asare M, Obiri-Yeboah D, Enyan NIE, Nuer-Allornuvor G, Fosu ES, Ken-Amoah S, Akakpo PK. An intervention to increase cervical cancer screening among women living with HIV: A mixed methods study. Patient Educ Couns. 2024 Jan;118:107993. doi: 10.1016/j.pec.2023.107993. Epub 2023 Oct 5.

    PMID: 37844427BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsLiteracy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCommunicationBehavior

Study Officials

  • Padam Simkhada, PhD

    University of Chester

    STUDY CHAIR
  • Bibha Simkhada, PhD

    University of Huddersfield

    STUDY CHAIR

Central Study Contacts

Joshua Okyere, MPhil

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2026

First Posted

August 4, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

August 4, 2026

Record last verified: 2026-07

Locations