NCT06371469

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

April 20, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

April 14, 2024

Last Update Submit

May 23, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

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

Control Group

ACTIVE COMPARATOR

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

PHeBACBEHAVIORAL

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

Also known as: Intervention Group
Experimental
Control GroupBEHAVIORAL

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

Control Group

Eligibility Criteria

Age30 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMothers of intellectual disabled children will be included.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Health BehaviorIntellectual Disability

Interventions

Control Groups

Condition Hierarchy (Ancestors)

BehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Habibe OZCELIK, PhD

    Akdeniz University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Habibe OZCELIK, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Dr

Study Record Dates

First Submitted

April 14, 2024

First Posted

April 17, 2024

Study Start

April 20, 2024

Primary Completion

July 20, 2024

Study Completion

August 20, 2024

Last Updated

May 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations