Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201802002902886 Date of Approval: 22/12/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Design and Evaluation of the Effect of Community Based Intervention on Breast Cancer Screening Behavior among Reproductive Age Women in Ethiopia: Clus
Official scientific title Design and Evaluation of the Effect of Community Based Intervention on Breast Cancer Screening Behavior among Reproductive Age Women in Ethiopia: Cluster Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Background: Breast cancer remains one of the deadliest non-communicable diseases in the world. Ethiopia is one of the countries with high breast cancer burden and faces the challenges from its devastating effects in terms of morbidity and mortality. According to the 2016 National Cancer Registry report of Ethiopia, it accounts for 33.4% of total cancer diagnoses in women. Therefore, the aim of this study is to design and evaluate community based intervention on breast cancer screening behavior among Ethiopian women. Methods and materials: A community based randomized controlled trial proceeded by cross sectional study lasting for six months will be conducted in Hadiya Zone, Ethiopia. For this, thirty clusters will be randomized by multistage cluster randomization technique, and allocated into two groups by permutation balanced block randomization. A total of 810 participants will be enrolled to the study by systematic random sampling technique. Educational intervention will be provided for the intervention group, while control group will be followed without any intervention. Structured questionnaire will be used for data collection. For data analysis, multilevel logistic regression model will be used to consider for the intra-cluster correlation effect. Individual participants will be considered at the first level and each cluster considered at second level. Conclusion: This will be the first study of its kind in Ethiopia to design and evaluate community based intervention on breast screening uptake. Therefore, it gives the opportunity to recognize the value of interventions and explore new intervention mechanism with an accurate method rather than the mere description of the problem.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Breast cancer,Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/04/2017
Actual trial start date 01/04/2018
Anticipated date of last follow up 31/10/2018
Actual Last follow-up date 31/10/2018
Anticipated target sample size (number of participants) 810
Actual target sample size (number of participants) 810
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Educational Intervention 6 months 6 months for 1:30-2:00 hours Educational intervention will be prepared based on health belief model constructs and distal factors which are interlinked with breast screening behavior. Educational intervention will be provided on mammography, breast self-examination and breast clinical exam by training and teaching using different methods and materials like posters and brochures. 405
Experimental Group Educational intervention for six months (every two weeks) for six months (every two weeks) Educational intervention will be prepared based on health belief model constructs. Educational intervention will be provided on mammography, breast self-examination and breast clinical exam by training and teaching using different methods and materials like posters and brochures. 405
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Women in reproductive age group 2.Women who are physically and mentally capable to provide informed consent, and can follow intervention provided without any support 3.Willing to participate and give data to the researcher. 1.A participant who has already attended another intervention program. 2.Participants who cannot stay until the intervention is completed/moveable participants during intervention time 6 Month(s) 1 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/11/2017 Ethics committee of Tehran University Medical Sciences
Ethics Committee Address
Street address City Postal code Country
resdeputy@tums.ac.ir Tehran 1417653761 Iran (Islamic Republic of)
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Increased knowledge Baseline, at 3 months and six months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Southern Ethiopia of Hadiya Zone Hossana, Ethiopia Hossana P.O.box: 6 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
International Campus of Tehran University of Medical Sciences Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd, Tehran, 1417653761, I.R.Iran 1417653761 Iran (Islamic Republic of)
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International Campus of Tehran University of Medical Sciences Tehran, Iran Tehran 1417653761 Iran (Islamic Republic of) University
COLLABORATORS
Name Street address City Postal code Country
Federal Ministry of health Addis Ababa, Ethiopia Addis Ababa 251 Iran (Islamic Republic of)
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Feleke Doyore Agide feledoag@yahoo.com +989309286231 South Palestine Street, Hojjatdoust Alley
City Postal code Country Position/Affiliation
Tehran Iran (Islamic Republic of) Lecturer at Wachemo University
Role Name Email Phone Street address
Public Enquiries Roya Sadeghi sadeghir@tums.ac.ir +989123275692 South Palestine Street, Hojjatdoust Alley
City Postal code Country Position/Affiliation
Tehran Iran (Islamic Republic of) (PhD, Associate Professor), Tehran University of medical sciences
Role Name Email Phone Street address
Scientific Enquiries Feleke Doyore Agide feledoag@yahoo.com +989309286231 South Palestine Street, Hojjatdoust Alley
City Postal code Country Position/Affiliation
Tehran Iran (Islamic Republic of) Lecturer at Wachemo University
REPORTING
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