Clinical trial NCT04304404: Risk Reduction Program for Women Having High Risk of Breast Cancer
Official title: The Effect of Risk Reduction Program Applied to Women With High Breast Cancer Risk on Participation in Screening, Health Beliefs and Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Screening
Early Detection of Cancer
Breast Cancer
Preventive Health Care
Health Behavior
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 77
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Exclusion Criteria:

* Having been diagnosed with breast cancer (first degree relative)
* Being pregnant or breastfeeding

Primary outcomes:
measure: Breast Cancer Screening
timeFrame: 12 weeks
measure: Health Belief Model Scale (Susceptibility, Health Motivation sub-factors)
timeFrame: 12 weeks
measure: Breast Cancer Fear Scale
timeFrame: 12 weeks
measure: Healthy Lifestyle Behaviors Scale II (Health Responsibility, Physical Activity and Nutrition Sub-Scale)
timeFrame: 12 weeks
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
affiliation: Akdeniz University
name: Sebahat GÖZÜM
role: STUDY_DIRECTOR
References: