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Risk Reduction Program for Women Having High Risk of Breast Cancer (BrCaRRP)

Primary Purpose

Cancer Screening, Early Detection of Cancer, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Breast Cancer Risk Reduction Program (BrCaRRP)
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cancer Screening

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Akdeniz University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group (BrCaRRP)

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Breast Cancer Screening
The primary outcome measure of the study is the participation rate of first degree relatives in breast cancer screenings.
Health Belief Model Scale (Susceptibility, Health Motivation sub-factors)
Health Belief Model Scale (Susceptibility, Health Motivation sub-factors)Health Motivation' sub-dimensions of Champion's Health Belief Model Scale will be used in this study. Sensitivity sub-dimension consists of 3 items, and Health Motivation sub-dimension consists of 5 items. In this 5-point Likert type scale, the items are scored as follows: "totally disagree" (1), "disagree" (2), "undecided" (3), "agree" (4), "totally agree" ( 5). All items of this scale are positive. Total score ranges from 8 to 40. Higher scores indicate higher sensitivity and health motivation. The scale contains no reverse items.
Breast Cancer Fear Scale
Champion's Breast Cancer Fear Scale consists of two sub-dimensions and eight items. It consists of five items related to thought and three items related to physiological stimulation. In this 5-point Likert type scale, the items are scored as follows: "totally disagree" (1), "disagree" (2), "undecided" (3), "agree" (4), "totally agree" (5). Total score ranges from 8 to 40. As the score increases, the level of breast cancer fear increases. The scale contains no reverse items.
Healthy Lifestyle Behaviors Scale II (Health Responsibility, Physical Activity and Nutrition Sub-Scale)
All items of the Healthy Lifestyle Behaviors Scale are positive and are structured as 4-point Likert type items. The scoring is as follows: never (1), sometimes (2), often (3), regularly (4). The scale consists of six sub-dimensions. Only 'Health Responsibility, Physical Activity and Nutrition' sub-dimensions were used in this study. The lowest score that can be obtained from these three sub-dimensions is 26 and the highest score that can be obtained is 104. Higher scores indicate more healthy lifestyle behaviors.
International Physical Activity Questionnaire (IPAQ)
IPAQ short form that will be used in this study consists of four sub-dimensions (Severe Physical Activity, Moderate Physical Activity, Mild Physical Activity, and Sitting Times) and seven items. The time spent on mild, moderate and severe activities as well as sitting times and the energy spent in these activities are calculated. The severity, frequency and duration of the activities performed for 10 minutes or longer in the last seven days are evaluated and the activity level is determined as metabolic equivalent (MET). Walking is 3.3 MET, moderate to severe physical activity is 4.0 MET, and severe physical activity is 8.0 MET. The 'MET-min/week' value is obtained by multiplying the MET value of each physical activity level with the days and minutes this physical activity is performed every week. The obtained MET value is classified as severe physical activity (MET>3000), moderate physical activity (MET = 600-3000), and mild physical activity (MET <600).

Secondary Outcome Measures

Full Information

First Posted
March 9, 2020
Last Updated
July 18, 2023
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT04304404
Brief Title
Risk Reduction Program for Women Having High Risk of Breast Cancer
Acronym
BrCaRRP
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Screening, Early Detection of Cancer, Breast Cancer, Preventive Health Care, Health Behavior

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group (BrCaRRP)
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
An information note will be given to the control group. The post-tests will be collected at the end of 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Breast Cancer Risk Reduction Program (BrCaRRP)
Other Intervention Name(s)
İntervention Group (BrCaRRP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Breast Cancer Screening
Description
The primary outcome measure of the study is the participation rate of first degree relatives in breast cancer screenings.
Time Frame
12 weeks
Title
Health Belief Model Scale (Susceptibility, Health Motivation sub-factors)
Description
Health Belief Model Scale (Susceptibility, Health Motivation sub-factors)Health Motivation' sub-dimensions of Champion's Health Belief Model Scale will be used in this study. Sensitivity sub-dimension consists of 3 items, and Health Motivation sub-dimension consists of 5 items. In this 5-point Likert type scale, the items are scored as follows: "totally disagree" (1), "disagree" (2), "undecided" (3), "agree" (4), "totally agree" ( 5). All items of this scale are positive. Total score ranges from 8 to 40. Higher scores indicate higher sensitivity and health motivation. The scale contains no reverse items.
Time Frame
12 weeks
Title
Breast Cancer Fear Scale
Description
Champion's Breast Cancer Fear Scale consists of two sub-dimensions and eight items. It consists of five items related to thought and three items related to physiological stimulation. In this 5-point Likert type scale, the items are scored as follows: "totally disagree" (1), "disagree" (2), "undecided" (3), "agree" (4), "totally agree" (5). Total score ranges from 8 to 40. As the score increases, the level of breast cancer fear increases. The scale contains no reverse items.
Time Frame
12 weeks
Title
Healthy Lifestyle Behaviors Scale II (Health Responsibility, Physical Activity and Nutrition Sub-Scale)
Description
All items of the Healthy Lifestyle Behaviors Scale are positive and are structured as 4-point Likert type items. The scoring is as follows: never (1), sometimes (2), often (3), regularly (4). The scale consists of six sub-dimensions. Only 'Health Responsibility, Physical Activity and Nutrition' sub-dimensions were used in this study. The lowest score that can be obtained from these three sub-dimensions is 26 and the highest score that can be obtained is 104. Higher scores indicate more healthy lifestyle behaviors.
Time Frame
12 weeks
Title
International Physical Activity Questionnaire (IPAQ)
Description
IPAQ short form that will be used in this study consists of four sub-dimensions (Severe Physical Activity, Moderate Physical Activity, Mild Physical Activity, and Sitting Times) and seven items. The time spent on mild, moderate and severe activities as well as sitting times and the energy spent in these activities are calculated. The severity, frequency and duration of the activities performed for 10 minutes or longer in the last seven days are evaluated and the activity level is determined as metabolic equivalent (MET). Walking is 3.3 MET, moderate to severe physical activity is 4.0 MET, and severe physical activity is 8.0 MET. The 'MET-min/week' value is obtained by multiplying the MET value of each physical activity level with the days and minutes this physical activity is performed every week. The obtained MET value is classified as severe physical activity (MET>3000), moderate physical activity (MET = 600-3000), and mild physical activity (MET <600).
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebahat GÖZÜM
Organizational Affiliation
Akdeniz University
Official's Role
Study Director
Facility Information:
Facility Name
Akdeniz University
City
Antalya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Risk Reduction Program for Women Having High Risk of Breast Cancer

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