Risk Reduction Program for Women Having High Risk of Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2021-09-01

Brief Summary

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An intervention program involving education, guidance, counseling, case management and surveillance based on the Health Belief Model will be implemented on women with high risk of breast cancer. The impact of the breast cancer risk reduction program on participation in breast cancer screenings, health beliefs (health motivation, sensitivity, fear of breast cancer) and behaviors (physical activity, nutrition, health responsibility, genetic counseling) will be evaluated in the study.

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Detailed Description

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In women with family history of breast cancer, cancer risk increases at least twice as compared to the population of the same age. The aim of this study is to evaluate the impact of the intervention program based on the Health Belief Model involving education, guidance, counseling, case management and surveillance, on participation in breast cancer screenings, health beliefs and behaviors in women with high risk of breast cancer.

This study protocol describes a randomized controlled trial with parallel group design. First degree biological relatives (mother, daughter, sister) of breast cancer patients who are diagnosed with breast cancer at or under the age of 50 and who apply to the Oncology Department will be randomly assigned to the intervention and control group.

The content of the Breast Cancer Risk Reduction Program created for the Intervention Group was planned according to the Health Belief Model (HBM) theoretical framework. The interventions based on HBM were carried out according to the OMAHA nursing interventions categories used in the field of Public Health Nursing (training, guidance, counseling, case management and surveillance). Breast Cancer Risk Reduction Program (BirCarrePro) is a 12-week program that includes six interviews. The first intervention in this group will begin with a 60-minute face-to-face individual training. After the first face-to-face interview, phone calls will be made in the second, third, sixth, ninth, and twelfth weeks. Pre-tests and post-tests will be completed by the participants via electronic questionnaires. Follow-up questionnaires will be applied by repeating the post-test at the 24th week. In the control group, post-test will be applied 12 weeks after the pre-test, and follow-up questionnaires will be applied 24 weeks after the pre-test.

Conditions

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Cancer Screening Early Detection of Cancer Breast Cancer Preventive Health Care Health Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention group (BrCaRRP)

Individual interventions based on the Health Belief Model and the The Health Promotion Model involving education, guidance, counseling, case management and surveillance for women with high breast cancer risk

Group Type EXPERIMENTAL

Breast Cancer Risk Reduction Program (BrCaRRP)

Intervention Type BEHAVIORAL

Women in the intervention group will complete the pre-tests electronically, and a 12-week intervention program will be implemented. The first meeting will be face-to-face individual training. In this training session, the risk of developing breast cancer will be calculated with each participant using breast cancer risk assessment tools. Modifiable and non-modifiable factors that increase breast cancer risk will be explained. With the participant, it will be decided which of the modifiable risk factors will be improved. Guidance will be given on topics such as genetic counseling, breast cancer screenings, increasing physical activity, healthy nutrition, weight control, smoking and alcohol use. The interventions will continue with phone calls and the 12-week program will be completed.

Control Group

An information note will be given to the control group. The post-tests will be collected at the end of 12 weeks

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Breast Cancer Risk Reduction Program (BrCaRRP)

Women in the intervention group will complete the pre-tests electronically, and a 12-week intervention program will be implemented. The first meeting will be face-to-face individual training. In this training session, the risk of developing breast cancer will be calculated with each participant using breast cancer risk assessment tools. Modifiable and non-modifiable factors that increase breast cancer risk will be explained. With the participant, it will be decided which of the modifiable risk factors will be improved. Guidance will be given on topics such as genetic counseling, breast cancer screenings, increasing physical activity, healthy nutrition, weight control, smoking and alcohol use. The interventions will continue with phone calls and the 12-week program will be completed.

Intervention Type BEHAVIORAL

Other Intervention Names

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İntervention Group (BrCaRRP)

Eligibility Criteria

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Inclusion Criteria

* Volunteering to participate in the study
* Being the first degree biological relative of a primary breast cancer patient diagnosed at or before the age of 50
* Aged 25 or older
* No mammography and/or MRI in the last 18 months
* Being literate