Clinical trial NCT06371469: Program of Health Behaviour Against to Cancer (PHeBAC)
Official title: The Effect of the Against to Cancer Health Behavior Program Applied to Mothers of Intellectual Disabled Children on Cancer Screenings and Preventive Health Behaviors: Nonrandomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Prevention
Health Behavior
Disability, Intellectual
Parents
Cancer Screening
Experimental Study Designs
Mothers
Disabilities Mental
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 46
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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

Primary outcomes:
measure: Health Behaviors and Participation in Cancer Screenings Data Collection Form
timeFrame: 8 weeks
measure: Healthy Life Style Behaviors Scale II (Physical Activity and Nutrition Sub-Factors)
timeFrame: 8 weeks
measure: Sun Protection Behavior Scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
affiliation: Akdeniz University
name: Habibe OZCELIK, PhD
role: PRINCIPAL_INVESTIGATOR
References: