Program of Health Behaviour Against to Cancer (PHeBAC)

NCT ID: NCT06371469

Last Updated: 2024-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-20

Study Completion Date

2024-08-20

Brief Summary

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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

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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.

Conditions

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Cancer Prevention Health Behavior Disability, Intellectual Parents Cancer Screening Experimental Study Designs Mothers Disabilities Mental

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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

Study Groups

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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.

Group Type EXPERIMENTAL

PHeBAC

Intervention Type BEHAVIORAL

Multi-interventions to health behaviour against cancer in mothers of Intellectual Disabled Children

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.

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type BEHAVIORAL

Providing brochures from the Ministry of Health, answering questions and providing the researcher's phone number

Interventions

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PHeBAC

Multi-interventions to health behaviour against cancer in mothers of Intellectual Disabled Children

Intervention Type BEHAVIORAL

Control Group

Providing brochures from the Ministry of Health, answering questions and providing the researcher's phone number

Intervention Type BEHAVIORAL

Other Intervention Names

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Intervention Group

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Habibe ÖZÇELİK

Lecturer Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Habibe OZCELIK, PhD

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University

Locations

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Akdeniz University

Antalya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Habibe OZCELIK, PhD

Role: CONTACT

+90544 576 2248

Facility Contacts

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Lecturer

Role: primary

Other Identifiers

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KAEK-769

Identifier Type: -

Identifier Source: org_study_id

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