NCT04225741

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
285

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jan 2015

Status
completed

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

Study Start

First participant enrolled

January 22, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2017

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

2.6 years

First QC Date

January 9, 2020

Last Update Submit

January 10, 2020

Conditions

Keywords

MammographyBreast self-examinationEarly diagnosis

Outcome Measures

Primary Outcomes (1)

  • Breast Cancer Worry Scale

    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.

    6 months

Study Arms (2)

training group

EXPERIMENTAL

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

Behavioral: Training group

Control Group

NO INTERVENTION

None of the interventions described above were applied to the control group.

Interventions

Training groupBEHAVIORAL

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. Furthermore, this model not only explains behavior regarding screening, but also evaluates the cognitive factors that facilitate health-promoting behaviors.

training group

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Missing data collection forms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Timur Tashan S, Ucar T, Aksoy Derya Y, Nacar G, Erci B. Validity and Reliability of the Turkish Version of the Modified Breast Cancer Worry Scale. Iran J Public Health. 2018 Nov;47(11):1681-1687.

Related Links

MeSH Terms

Conditions

Breast NeoplasmsBreast Self-ExaminationDisease

Interventions

Sensitivity Training Groups

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSelf-ExaminationHealth BehaviorBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Gülçin NACAR, Msc

    Inonu University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 13, 2020

Study Start

January 22, 2015

Primary Completion

August 11, 2017

Study Completion

August 30, 2017

Last Updated

January 14, 2020

Record last verified: 2020-01