NCT06311565

Brief Summary

The aim of this study is to examine the effect of the education given to individuals undergoing colorectal cancer screening on their attitudes, beliefs and healthy lifestyle behaviors. This study was planned to be conducted as a prospective randomized controlled study in a family health center in Istanbul. The universe of the research; The sample of individuals registered to the family health center will consist of a total of 70 individuals who meet the inclusion criteria for the study. Patient Diagnosis Form, Colorectal Cancer Screening Attitude Belief Scale, Healthy Lifestyle Behavior Scale II will be used to collect data. Data will be collected at the first encounter, 1 month later, 3 months later, pre-test and post-test. In the research, individuals will be divided into two groups: intervention (n = 35) and control (n = 35). Training will be provided to the intervention group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 30, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

February 4, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

March 8, 2024

Last Update Submit

February 1, 2025

Conditions

Keywords

colorectal cancercancer screeninghealthy lifestyleeducation

Outcome Measures

Primary Outcomes (2)

  • Colorectal cancer screening attitude belief scale

    Scale; It consists of five subscales: relevance and consistency, perception of sensitivity, response effectiveness, cancer anxiety, and social influence. There are 16 items in the scale. The scale is in 5-point Likert style and the answer options for each item are; It is evaluated as "strongly disagree" (1 point), "disagree" (2 points), "don't know" (3 points), "agree" (4 points) and "strongly agree" (5 points).

    Baseline, after one month and after three months

  • Healthy lifestyle behaviors scale II

    The scale consists of 52 items and six factors. These; health responsibility, physical activity, nutrition, spiritual development, interpersonal relationships and stress management. Scale rating is 4-point Likert type. Expressions such as never (1), sometimes (2), often (3), regularly (4) are accepted. The lowest score that can be obtained from the entire scale is 52 and the highest score is 208.

    Baseline, after one month and after three months

Study Arms (2)

Education

EXPERIMENTAL

People who have undergone colorectal cancer screening will be given training on colorectal cancer prevention. Training will be carried out face to face and individually. The training will take approximately 25-30 minutes.

Behavioral: Education

Control

NO INTERVENTION

Individuals in this group will be screened for colorectal cancer. However, this group will not be given any training on cancer prevention.

Interventions

EducationBEHAVIORAL

Individuals in this group will be trained on acquiring healthy lifestyle behaviors to protect against colorectal cancer. Training will be individual, face-to-face and in the form of question and answer. At the end of the training, training brochures prepared by the researchers after taking expert opinions will be distributed to the participants. The training will take approximately 25-30 minutes. The training will take place in the training hall at the family health center.

Education

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 50-70 years old,
  • Registered at the Family Health Center,
  • Able to speak Turkish,
  • No diagnosis of psychiatric disease and no history of anxiolytic drug use,
  • They will have a Fecal Occult Blood test for the first time,
  • Positive result of fecal occult blood test,
  • Faecal occult blood test was positive and had a colonoscopy,
  • Those who have not been diagnosed with colorectal cancer as a result of colonoscopy,
  • Individuals who volunteer to participate in the research

You may not qualify if:

  • Having had previous colon surgery,
  • Individuals with a history of colorectal cancer will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hilal KARTAL

Istanbul, Beylikdüzü, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled ( experimental and control group)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student, principal investigator

Study Record Dates

First Submitted

March 8, 2024

First Posted

March 15, 2024

Study Start

April 30, 2024

Primary Completion

October 30, 2024

Study Completion

December 30, 2024

Last Updated

February 4, 2025

Record last verified: 2025-02

Locations