Program of Health Behaviour Against to Cancer (PHeBAC) (PHeBAC)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parents; Health Behavior; Disabilities Mental; Mothers; Cancer Screening; Cancer Prevention; Disability, Intellectual; Experimental Study Designs
• Intervention / Treatment: Behavioral: PHeBAC; Behavioral: Control Group

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Habibe OZCELIK, PhD; Phone Number: +90544 576 2248; Email: hozcelik@akdeniz.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Those who have at least one intellectual disabled child receiving education at Special Education Application Center schools,
• Those who are 30 years of age and above and have not had cervical cancer screening with HPV or smear test in the last five years,
• Those who are 40 years or older and have not had breast cancer screening with mammography in the last 18 months,
• Those who are 50 years or older and have not had a fecal occult blood test in the last two years.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; PHeBAC is an acronym that defines multi-interventions to health behaviour against cancer. The intervention group will receive PHeBAC with multiple interventions including education, guidance, counseling, and case management in line with the 12 European Codes Against Cancer to reduce cancer risk. The PHeBAC interventions will be 8 weeks long, with two face-to-face and three telephone interviews. The first and the 4th week will be face-to-face with two different sessions of 45 minutes each; the 2nd, 6th, and 8th weeks will be phone calls of 15 minutes each.	Behavioral: PHeBAC; Multi-interventions to health behaviour against cancer in mothers of Intellectual Disabled Children; Other Names: Intervention Group
Active Comparator: Control Group; The active control group will be given brochures from the Ministry of Health on cancer prevention and cancer screening recommendations and their questions will be answered. Contact information of the researchers will be given and they will be told that they can call if they have any questions.	Behavioral: Control Group; Providing brochures from the Ministry of Health, answering questions and providing the researcher's phone number

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Behaviors and Participation in Cancer Screenings Data Collection Form	Developed by the researchers in line with the recommendations of the European Code Against Cancer. It includes information on smoking, secondhand smoke, alcohol use, HPV vaccination and cancer screenings.	8 weeks
Healthy Life Style Behaviors Scale II (Physical Activity and Nutrition Sub-Factors)	The scale consists of six sub-factors and two sub-factors, physical activity and nutrition, will be used. All items of the scale are positive. As the score increases, the level of physical activity and nutrition increases. The physical activity sub-factor consists of 8 items and the nutrition sub-factor consists of 9 items. The 4-point Likert scale is accepted as never (1), sometimes (2), frequently (3), and regularly (4).	8 weeks
Sun Protection Behavior Scale	It examines the sun protection behavior of the individual when the sun exposure time is more than 15 minutes. The scale consists of three sub-factors: regular sun avoidance, sunscreen use and hat use. All items of the scale are positive. As the score increases, sun protection behaviors increase. Sun avoidance consists of three items, sunscreen use consists of three items and hat use consists of two items. On a 5-point Likert scale, (1) is considered as never, (2) rarely, (3) sometimes, (4) usually and (5) always.	8 weeks

Collaborators and Investigators

• Sponsor: Akdeniz University
• Investigators: Principal Investigator: Habibe OZCELIK, PhD, Akdeniz University

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2024
• Primary Completion (Estimated): July 20, 2024
• Study Completion (Estimated): August 20, 2024

Study Registration Dates

• First Submitted: April 14, 2024
• First Submitted That Met QC Criteria: April 14, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Intellectual Disability
• Other Study ID Numbers: KAEK-769

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No