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Trial Title:
Program of Health Behaviour Against to Cancer (PHeBAC)
NCT ID:
NCT06371469
Condition:
Cancer Prevention
Health Behavior
Disability, Intellectual
Parents
Cancer Screening
Experimental Study Designs
Mothers
Disabilities Mental
Conditions: Official terms:
Intellectual Disability
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
Mothers participating in the research will not know that they are in the intervention or
control group. The data of the research will be collected by an independent investigator.
In addition telephone support during the research process will be provided by the
independent investigator, too
Intervention:
Intervention type:
Behavioral
Intervention name:
PHeBAC
Description:
Multi-interventions to health behaviour against cancer in mothers of Intellectual
Disabled Children
Arm group label:
Experimental
Other name:
Intervention Group
Intervention type:
Behavioral
Intervention name:
Control Group
Description:
Providing brochures from the Ministry of Health, answering questions and providing the
researcher's phone number
Arm group label:
Control Group
Summary:
The European Code Against Cancer contains 12 recommendations to reduce the risk of
cancer. It is estimated that about half of all cancers could be prevented if all
recommendations are followed.
The aim of this study was to evaluate the effectiveness of the Program of Health
Behaviour Against Cancer (PHeBAC) applied to mothers of children with intellectual
disabilities in increasing the participation of mothers and their children with
intellectual disabilities in cancer screenings and their health behaviors against cancer.
The goal is to improve the preventive health behaviors of children with intellectual
disabilities and their mothers against cancer and to increase the rate of participation
in cancer screenings. Specific targets are; not smoking and not being exposed to smoking,
increasing physical activity, healthy nutrition, limiting alcohol consumption, protection
from sunlight, HPV vaccination and increasing participation in breast, cervical and
colorectal cancer screenings.
Detailed description:
Intervention Group: Program of Health Behaviour Against Cancer (PHeBAC): PHeBAC is an
8-week program consisting of five interviews, two face-to-face and three by telephone.
Face-to-face training will be provided in two different sessions of 45 minutes each in
the first and 4th weeks, and telephone interviews of 15 minutes each in the 2nd, 6th and
8th weeks.
Each planned intervention will be organized by taking the opinions of experts working in
this field. In addition, expert opinions will be taken for the content of the
presentation of face-to-face individual trainings to the intervention group.
The pre-tests of the study will be collected just before the training in week 0 and the
post-tests will be collected in week 9. Data collection forms will be filled in by the
participants under the supervision of the researcher.
Intervention to be applied to the Control Group: Participants in the active control group
will be invited for a face-to-face interview and the pretests will be completed by the
participants under the supervision of the researcher. After the pre-tests are taken, the
participants will be informed about the brochure of the Ministry of Health, which
includes cancer prevention recommendations and cancer screening recommendations, and the
content of the brochure. The contact information of the researchers will be given and
they will be told that they can call if they have any questions. The post-tests will be
completed in the ninth week. Data collection forms will be completed by the participants
under the supervision of the researcher.
The data of the study will be evaluated using "the Health Behaviors and Participation in
Cancer Screenings Data Collection Form developed by the researchers", "Healthy Lifestyle
Behaviors Scale II-Physical Activity and Nutrition Sub-Factors", "Sun Protection Behavior
Scale". IBM SPSS 23 and Gpower programs will be used for statistical analysis of the data
obtained from the study. The distribution of the data will be evaluated with Skewness and
Kurtosis. For continuous data showing normal distribution, t test in two dependent
groups, Student t test in two independent groups, One-way ANOVA test will be performed.
For categorical data, McNemar test in two dependent groups and chi-square test in two
independent groups will be performed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Those who have at least one intellectual disabled child receiving education at
Special Education Application Center schools,
Exclusion Criteria:
- Caregivers other than the mother of the intellectual disabled child
- Mothers who are being followed up with a diagnosis of breast, cervix or colorectal
cancer
Disqualification Criteria:
- Mothers in the PheBAC group who do not continue with the telephone meetings after
the face-to-face interview
Gender:
Female
Gender based:
Yes
Gender description:
Mothers of intellectual disabled children will be included.
Minimum age:
30 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Akdeniz University
Address:
City:
Antalya
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Lecturer
Start date:
April 20, 2024
Completion date:
August 20, 2024
Lead sponsor:
Agency:
Akdeniz University
Agency class:
Other
Source:
Akdeniz University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06371469