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Theory-based Training to Promote Breast Cancer Screening (cancer)

Primary Purpose

Breast Cancer, Breast Cancer Female

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Training group
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Mammography, Breast self-examination, Early diagnosis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    training group

    Control Group

    Arm Description

    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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 9, 2020
    Last Updated
    January 10, 2020
    Sponsor
    Inonu University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04225741
    Brief Title
    Theory-based Training to Promote Breast Cancer Screening
    Acronym
    cancer
    Official Title
    Theory-based Training to Promote Breast Cancer Screening Among Women With Breast Cancer Worries: Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 22, 2015 (Actual)
    Primary Completion Date
    August 11, 2017 (Actual)
    Study Completion Date
    August 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Inonu University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Breast Cancer Female
    Keywords
    Mammography, Breast self-examination, Early diagnosis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    285 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    training group
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    None of the interventions described above were applied to the control group.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Training group
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Breast Cancer Worry Scale
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gülçin NACAR, Msc
    Organizational Affiliation
    Inonu University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30581784
    Citation
    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.
    Results Reference
    result
    Links:
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/30581784
    Description
    Validity and Reliability of the Turkish Version of the Modified Breast Cancer Worry Scale.

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    Theory-based Training to Promote Breast Cancer Screening

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