CancerNCT06579625
The Effect of Health Belief Model-Based Cancer Education on Cancer Information Load, Knowledge and Attitudes Towards Cancer Screenings
A study testing Cancer education in people with Cancer and Education, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Participants will be randomly assigned to the experimental and control groups. The study will involve a total of 78 participants, with 39 in the experimental group and 39 in the control group. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- What is being tested?
- Cancer education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2024to 28 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who agree to participate in the study, are aged 30-70,
- Are literate,
- Do not have any auditory, visual, cognitive, or orthopedic disabilities that would prevent participation,
- Are not receiving palliative care services, will be included. This includes caregivers of cancer patients.
Who cannot join
- Individuals under the age of 30 or over the age of 70,
- Those who are illiterate,
- Those with disabilities that would prevent participation in the study,
- Those who provide care for cancer patients receiving palliative care services will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Abdurrhman Yurtaslan Oncology Education and Research Hospital
Ankara, 06200
About this study
Official title: The Effect of Health Belief Model-Based Cancer Education Given to Caregivers of Cancer Patients on Cancer Information Load, Knowledge and Attitudes Towards Cancer Screenings
Participants will be randomly assigned to the experimental and control groups. The study will involve a total of 78 participants, with 39 in the experimental group and 39 in the control group. The 39 participants assigned to the experimental group will first complete the cancer knowledge burden, and attitudes and information about cancer screenings scales. They will then receive cancer education consisting of four modules, which will be completed over four weeks. At the end of these four weeks, they will complete the scales again. One month after the education, the experimental group will complete the scales once more for follow-up monitoring. The control group will first complete the cancer knowledge burden, and attitudes and information about cancer screenings scales after agreeing to participate in the study. They will complete the scales again one month later. The evaluation of the education in the experimental group will involve comparing the scales completed before and after the education.
Read the detailed description
Cancer is a significant public health issue with high morbidity and mortality rates worldwide and in our country. According to cancer statistics published by the World Health Organization\'s International Agency for Research on Cancer, the number of people diagnosed with cancer increases every year. In 2022, the global number of new cancer cases was 20 million, and it is estimated to reach 32.6 million by 2045. Cancer ranks second among all causes of death globally and in Turkey, with approximately one in every six individuals succumbing to cancer according to WHO estimates. The increasing number of cancer cases day by day unders cores the importance of cancer as it exerts physical, emotional, and financial pressure on individuals, families, and society and is a significant cause of death.
In secondary prevention methods for cancer prevention, early diagnosis and screening programs encompass the diagnosis and treatment of the disease before it progresses. In our country, cancer screenings include breast cancer, cervical cancer, and colon cancer screenings. It is important to raise awareness in the community about early diagnosis and screening programs for cancer. All individuals in the society should learn the causes, risk factors, and symptoms of cancer from accurate and reliable sources. Research results indicate that participants knowledge about cancer screenings is not at a sufficient level. With the high prevalence of cancer in society, individuals are increasingly seeking information about cancer. However, as knowledge about cancer increases, individuals may experience information overload, which can lead to confusion. Studies have shown that as the burden of cancer knowledge increases, individuals tend to avoid cancer-related information and engage in fewer health-protective, preventive behaviors.
The Health Belief Model pos its that individuals health behaviors are influenced by beliefs, values, and attitudes and is frequently used in health education. The primary aim of the Health Belief Model is to understand what motivates individuals to engage in preventive behaviors, to undergo health screenings forearly diagnosis, and to control the in diseases, and to develop interventions tailored to the individual. This study aims to evaluate the effect of cancer educati on based on the Health Belief Model on the knowled geand attitudes towards cancer screenings among caregivers of cancer patients.
The population of the study consists of individual sproviding care to cancer patients who have agreed to participate in the research, aged between 30 and 70 years, literate, and with out anyyisual, auditory, intellectual, or orthopedic impairments. Th eincluded individuals (78 caregivers) will be stratified by the clinics where they provide care and weighted according to the number of inpatients they carefor. The experimental and control groups will be listed and numbered separately for each clinic, and random sampling will be conducted using a real random number generator (https://www.random.org/). Random selections will be planned sequentially, with one experimental and one control group alternately. Selection will continue until the sample size is reached. As part of thepre-test, the introductory information form, Cancer Knowledge Scale, Cancer Screening Knowledge Scale, and Cancer Screening Attitude Scale will be administered to individuals in both the experimental and control groups. The experimental group will receive a 4-week cancer education program based on the Health Belief Model, while no interventi on will be made for the control group. As part of the post-test, the Cancer Knowledge Scale, Cancer Screening Knowledge Scale, and Cancer Screening Attitude Scale will be administered to both the experimental and control groups. Data analysis will be performed using the Statistical Package for Social Sciences (SPSS) 25.0 program.
Cancer screenings ensure the early detection of cancer. Cancers diagnosed in the early stages are easier, faster, and more cost-effective to cure and treat compared to advanced-stage cancers. This study may provide guid an ceto caregivers of cancer patients by increasing their knowledge about cancer and cancer screening programs, reducing the burden of cancer knowledge, and increasing participation rates in screenin gprograms. Additionally, this study may shed light on the impact of cancer education on cancer knowledge, screening knowledge, and attitudes among individuals with different demographic characteristics.
- Conditions
- Cancer, Education, Caregiver, Randomised Controlled Trial
- Being tested
- Cancer education
- Keywords
- Cancer, Cancer Screening, Caregiver, Health Belief Model, Information, Attitude, Health Education
- Medical subject headings
- Neoplasms, Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer educationOther
Participants in the experimental group will receive cancer education.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Other | The effect of cancer education on cancer knowledge burden, information about cancer screenings, and attitudes will be evaluated by providing cancer education to 39 patients in the experimental group. Receives: Other: Cancer education |
| Control group | No intervention | The control group will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
İnformation Towards Cancer Screening Scale
The scale consists of 15 items and is unidimensional. It is a five-point Likert scale. The items on the scale are answered on a range from 1 to 5 as follows: \"5: Strongly agree, 4: Agree, 3: Neither agree nor disagree, 2: Disagree, 1: Strongly disagree.\"
The scale is suitable for use with men and women aged 30-70 who are at least literate and do not have cognitive, visual, or orthopedic disabilities that would prevent them from answering the scale. The administration method of the scale should be such that the researcher observes the participant, and the participant reads and answers the scale items independently. The scale can be used in any situation where it is necessary to measure attitudes towards cancer screenings, provided that the appropriate sample and administration method are used.
The lowest possible score on the scale is 15 and the highest is 75. There is no specific cutoff point for the scale. Scores close to 15 indicate
Measured: one month
Secondary outcomes (2)
Cancer Knowledge Burden
Cancer information overload was measured using a thirteen- item battery assessing feelings about the overwhelming quantity of cancer information. Four response options (strongly disagree to strongly agree) were provided for each item (i.e., higher scores for greater overload). Items were crafted based on HINTS questions, an explication of the construct (detailed in the literature review of this article), and formative research conducted by the authors.
Measured: one month
Attitudes Towards Cancer Screening Scale
The scale consists of 24 items and is unidimensional. It is a five-point Likert scale. The items on the scale are answered on a range from 1 to 5 as follows: \"5: Strongly agree, 4: Agree, 3: Neither agree nor disagree, 2: Disagree, 1: Strongly disagree.\"
The scale is suitable for use with men and women aged 30-70 who are at least literate and do not have cognitive, visual, or orthopedic disabilities that would prevent them from answering the scale. The administration method of the scale should be such that the researcher observes the participant, and the participant reads and answers the scale items independently. The scale can be used in any situation where it is necessary to measure attitudes towards cancer screenings, provided that the appropriate sample and administration method are used.
The lowest possible score on the scale is 24 and the highest is 120. There is no specific cutoff point for the scale. Scores close to 24 indicat
Measured: one mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start10 Sep 2024 (estimated)
- Primary completion10 Oct 2024 (estimated)
- Study completion28 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two group with a of Health Belief Model-Based cancer education control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semanur AKER, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579625
- Sponsor's protocol ID
- AnkaraU-HEM-SA-01
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Belief Model-Based Cancer Education Given to Caregivers of Cancer Patients on Cancer Information Load, Knowledge and Attitudes Towards Cancer Screenings
- ClinicalTrials.gov ID
- NCT06579625
- Acronym / sponsor ID
- AnkaraU-HEM-SA-01
- Conditions
- Cancer, Education, Caregiver, Randomised Controlled Trial
- Keywords
- Cancer, Cancer Screening, Caregiver, Health Belief Model, Information, Attitude, Health Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (estimated)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 28 Oct 2024 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will be randomly assigned to the experimental and control groups. The study will involve a total of 78 participants, with 39 in the experimental group and 39 in the control group. The 39 participants assigned to the experimental group will first complete the cancer knowledge burden, and attitudes and information about cancer screenings scales. They will then receive cancer education consisting of four modules, which will be completed over four weeks. At the end of these four weeks, they will complete the scales again. One month after the education, the experimental group will complete the scales once more for follow-up monitoring. The control group will first complete the cancer knowledge burden, and attitudes and information about cancer screenings scales after agreeing to participate in the study. They will complete the scales again one month later. The evaluation of the education in the experimental group will involve comparing the scales completed before and after the education.
Detailed description
Cancer is a significant public health issue with high morbidity and mortality rates worldwide and in our country. According to cancer statistics published by the World Health Organization\'s International Agency for Research on Cancer, the number of people diagnosed with cancer increases every year. In 2022, the global number of new cancer cases was 20 million, and it is estimated to reach 32.6 million by 2045. Cancer ranks second among all causes of death globally and in Turkey, with approximately one in every six individuals succumbing to cancer according to WHO estimates. The increasing number of cancer cases day by day unders cores the importance of cancer as it exerts physical, emotional, and financial pressure on individuals, families, and society and is a significant cause of death.
In secondary prevention methods for cancer prevention, early diagnosis and screening programs encompass the diagnosis and treatment of the disease before it progresses. In our country, cancer screenings include breast cancer, cervical cancer, and colon cancer screenings. It is important to raise awareness in the community about early diagnosis and screening programs for cancer. All individuals in the society should learn the causes, risk factors, and symptoms of cancer from accurate and reliable sources. Research results indicate that participants knowledge about cancer screenings is not at a sufficient level. With the high prevalence of cancer in society, individuals are increasingly seeking information about cancer. However, as knowledge about cancer increases, individuals may experience information overload, which can lead to confusion. Studies have shown that as the burden of cancer knowledge increases, individuals tend to avoid cancer-related information and engage in fewer health-protective, preventive behaviors.
The Health Belief Model pos its that individuals health behaviors are influenced by beliefs, values, and attitudes and is frequently used in health education. The primary aim of the Health Belief Model is to understand what motivates individuals to engage in preventive behaviors, to undergo health screenings forearly diagnosis, and to control the in diseases, and to develop interventions tailored to the individual. This study aims to evaluate the effect of cancer educati on based on the Health Belief Model on the knowled geand attitudes towards cancer screenings among caregivers of cancer patients.
The population of the study consists of individual sproviding care to cancer patients who have agreed to participate in the research, aged between 30 and 70 years, literate, and with out anyyisual, auditory, intellectual, or orthopedic impairments. Th eincluded individuals (78 caregivers) will be stratified by the clinics where they provide care and weighted according to the number of inpatients they carefor. The experimental and control groups will be listed and numbered separately for each clinic, and random sampling will be conducted using a real random number generator (https://www.random.org/). Random selections will be planned sequentially, with one experimental and one control group alternately. Selection will continue until the sample size is reached. As part of thepre-test, the introductory information form, Cancer Knowledge Scale, Cancer Screening Knowledge Scale, and Cancer Screening Attitude Scale will be administered to individuals in both the experimental and control groups. The experimental group will receive a 4-week cancer education program based on the Health Belief Model, while no interventi on will be made for the control group. As part of the post-test, the Cancer Knowledge Scale, Cancer Screening Knowledge Scale, and Cancer Screening Attitude Scale will be administered to both the experimental and control groups. Data analysis will be performed using the Statistical Package for Social Sciences (SPSS) 25.0 program.
Cancer screenings ensure the early detection of cancer. Cancers diagnosed in the early stages are easier, faster, and more cost-effective to cure and treat compared to advanced-stage cancers. This study may provide guid an ceto caregivers of cancer patients by increasing their knowledge about cancer and cancer screening programs, reducing the burden of cancer knowledge, and increasing participation rates in screenin gprograms. Additionally, this study may shed light on the impact of cancer education on cancer knowledge, screening knowledge, and attitudes among individuals with different demographic characteristics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two group with a of Health Belief Model-Based cancer education control group
| Arm | Type | Receives |
|---|---|---|
| experimental group | Other | Other: Cancer educationThe effect of cancer education on cancer knowledge burden, information about cancer screenings, and attitudes will be evaluated by providing cancer education to 39 patients in the experimental group. |
| Control group | No intervention | –The control group will not receive any intervention. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals who agree to participate in the study, are aged 30-70,
- Are literate,
- Do not have any auditory, visual, cognitive, or orthopedic disabilities that would prevent participation,
- Are not receiving palliative care services, will be included. This includes caregivers of cancer patients.
Key exclusion criteria (4 listed)
- Individuals under the age of 30 or over the age of 70,
- Those who are illiterate,
- Those with disabilities that would prevent participation in the study,
- Those who provide care for cancer patients receiving palliative care services will not be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cancer educationParticipants in the experimental group will receive cancer education. | Other | experimental group |
Primary outcome
İnformation Towards Cancer Screening Scale
Time frame: one month
The scale consists of 15 items and is unidimensional. It is a five-point Likert scale. The items on the scale are answered on a range from 1 to 5 as follows: \"5: Strongly agree, 4: Agree, 3: Neither agree nor disagree, 2: Disagree, 1: Strongly disagree.\" The scale is suitable for use with men and women aged 30-70 who are at least literate and do not have cognitive, visual, or orthopedic disabilities that would prevent them from answering the scale. The administration method of the scale should be such that the researcher observes the participant, and the participant reads and answers the scale items independently. The scale can be used in any situation where it is necessary to measure attitudes towards cancer screenings, provided that the appropriate sample and administration method are used. The lowest possible score on the scale is 15 and the highest is 75. There is no specific cutoff point for the scale. Scores close to 15 indicate
2 secondary outcomes
Cancer Knowledge Burden
Time frame: one month
Attitudes Towards Cancer Screening Scale
Time frame: one mounth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer education in people with Cancer and Education, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Semanur AKER (+90 05065448466, semaakeer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
İnformation Towards Cancer Screening Scale (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.