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RecruitingNCT06371469PHeBACUpdated May 24, 2024

Program of Health Behaviour Against to Cancer (PHeBAC)

An interventional study of PHeBAC and Control Group in Cancer Prevention, Health Behavior and Disability, Intellectual, sponsored by Akdeniz University. Recruiting at 1 site in Turkey. Open to female participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-24.

Sponsored by Akdeniz University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Non-randomized
Ages
30 Years to 70 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Cancer Prevention
  • Health Behavior
  • Disability, Intellectual
  • Parents
  • Cancer Screening
  • Experimental Study Designs
  • Mothers
  • Disabilities Mental
03

In context

Intellectual Disability

363 studies on the registry are indexed under Intellectual Disability; 103 are open to participants now.

This study's planned enrollment of 46 is below the median of 53 across 236 interventional studies indexed under Intellectual Disability.

Browse Intellectual Disability studies →

Lead sponsor

Akdeniz University is the lead sponsor of 289 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Those who have at least one intellectual disabled child receiving education at Special Education Application Center schools,

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
46 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralPHeBAC

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

    Also known as: Intervention Group

  • BehavioralControl Group

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

  2. 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).

    Time frame: 8 weeks

  3. 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.

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Akdeniz University
    Antalya, Turkey
    • Lecturer · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06371469
Lead sponsor
Akdeniz University
Responsible party
Habibe ÖZÇELİK (Lecturer Dr, Akdeniz University) — Principal investigator
First posted
Apr 17, 2024
Start date
Apr 20, 2024
Primary completion
Jul 20, 2024 (estimated)
Completion
Aug 20, 2024 (estimated)
Last update
May 24, 2024

Study contacts

Habibe OZCELIK, PhD
Contact
hozcelik@akdeniz.edu.tr
+90544 576 2248
Habibe OZCELIK, PhD
principal investigator · Akdeniz University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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