Theory-based Training to Promote Breast Cancer Screening

Not Applicable

Completed

• Conditions: Breast Cancer; Breast Cancer Female
• Interventions: Behavioral: Training group

• Registration Number: NCT04225741
• Lead Sponsor: Inonu University

Brief Summary

BACKGROUND: Breast cancer worries are important determinants in relation to behavior favoring breast cancer screening.

OBJECTIVE: To determine the effect of theory-based training to promote breast cancer screening among women with high and low levels of breast cancer worries.

DESIGN AND SETTING: Randomized controlled trial, conducted in two family health centers.

METHODS: In total, 285 women were recruited. Women with low levels of breast cancer worries were included in the first intervention group (112 women) and the first control group (112 women), while women with high levels of breast cancer worries were included in the second intervention group (37 women) and the second control group (43 women). Theory-based training to promote breast cancer screening was given to intervention groups. The women's willingness to undergo breast cancer screening and breast cancer worry scores were evaluated at 1, 3 and 6 months.

Detailed Description

Breast cancer is the most frequent type of cancer and the most common cause of cancer death among gynecological cancers. One in every four women with cancer in the world has breast cancer. The International Cancer Agency reported that there were around 2,088,849 new cases and 626,679 deaths due to breast cancer worldwide in 2018. The incidence of breast cancer is higher in developed countries than in developing countries, but the numbers of deaths due to breast cancer are lower in developed countries than in developing countries.

It is known that breast self-examination, clinical breast examination and mammography play an important role in making an early diagnosis of breast cancer. The uptake rate for mammography performed on a regular basis is low because this is an expensive method, considering that not all individuals have health insurance and public funding is inadequate, especially in developing countries. Hence, breast self-examination (which has no cost) and clinical breast examination (which only has low cost) remain important diagnostic methods. Moreover, during clinical breast examination, healthcare professionals have the opportunity to advise on breast cancer, risk factors, prevention methods and screening methods.

Study Timeline

• Study Start: 2015-01-22
• Primary Completion: 2017-08-11
• Study Completion: 2017-08-30
• Status Verified: 2020-01
• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-09
• Last Update Submitted: 2020-01-10
• Study First Posted: 2020-01-13
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 285

Inclusion Criteria

• The participants included did not have any diagnosis of breast cancer, had not been performing breast self-examination regularly (every month), had not previously had a mammogram, had not previously had a clinical breast examination, were not pregnant or breastfeeding and were literate.

Exclusion Criteria

• Missing data collection forms.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
training group	Training group	The single-session training lasted for approximately 40-45 minutes and was conducted in the training room of Sıtmapınarı family health center, as a suitable environment. The health belief model predicts the determinants of preventive health behaviors and explains inadequate participation in disease prevention and screening programs.22,23 Furthermore, this model not only explains behavior regarding screening, but also evaluates the cognitive factors that facilitate health-promoting behaviors.22-24

Primary Outcome Measures

Name	Time	Method
Breast Cancer Worry Scale	6 months	Breast Cancer Worry Scale: Lerman et al. developed this three-item scale to measure breast cancer worry levels and their effect on daily activities and mood. Lerman subsequently modified the scale, such that it was extended from breast cancer to general cancer and its number of questions was increased to six. Lerman's six-item cancer worry scale was then modified by Timur Taşhan et al. to measure breast cancer worries alone, and a Turkish validity and reliability study on the BCWS was conducted. Thus, overall, the lowest score that can be obtained is 0, and the highest is 24. A total score of less than 12 denotes a low level of worry regarding cancer, and a total score ≥ 12 indicates a high level of worry.