Gynecologic CancerNCT06318702
The Effect of Constructivist Learning Model Based Gynecological Cancer Education
A study testing Education in people with Gynecologic Cancer, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial summary
This is a randomised controlled study.The study was conducted to determine the effect of the constructivist education model given to women on gynecological cancer awareness, health Anxiety and spiritual well-being in women . The study population was composed of women living in Kastamonu. Read more about this study
- Who is it for?
- Ages 18 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2023to 20 Feb 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 18 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being 18 years old,
- being willing to participate in this study
Who cannot join
- having any neuropsychiatric disorder,
- having any physical or mental illness,
- being diagnosed with gynecological cancer,
- not attending theoretical trainings.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Constructivist Learning Model Based Gynecological Cancer Education on Gynecologic Cancer Awareness, Spiritual Well-being and Health Anxiety: A Randomized Controlled Trial
This is a randomised controlled study.The study was conducted to determine the effect of the constructivist education model given to women on gynecological cancer awareness, health Anxiety and spiritual well-being in women . The study population was composed of women living in Kastamonu. Women will be assigned to control and experimental groups. Women in the control group will receive gynecological education from Cancer Early Diagnosis, Screening and Education Centers (KETEM). The other group will receive gynecological cancer education based on the constructivist model.The hypotheses of the study are as follows:
H0: The of constructivist learning model -based health education programme does not have an effect on gynecologic cancer awareness, spiritual well-being and health anxiety.
H1: The of constructivist learning model -based health education programme have an effect on gynecologic cancer awareness, spiritual well-being and health anxiety.
- Conditions
- Gynecologic Cancer
- Being tested
- Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
is an education program implemented to raise women's awareness about reproductive health and to help them adopt healthy habits.
| Study group | Role | What they receive |
|---|---|---|
| KETEM | No intervention | This group was given a three-week standard gynecological cancer education program by the Cancer Early Diagnosis, Screening and Education Centers (KETEM) unit. |
| constructivist model group | Experimental | Gynecologic cancer education was given to the intervention group for 3 weeks based on the constructivist education model, taking into account the assimilation, adaptation and balancing stages of education. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
gynecologic cancer awareness
comparing the two groups in terms of gynecologic cancer awareness scores. Gynaecological cancer awareness scale will use for data collecting. This scale consists of 41 items and four sub-dimensions, with a minimum score of 41 and a maximum score of 205.The awareness of women is greater the higher the scores obtained from the scale.
Measured: before education, after education, 4 weeks after education
spiritual well-being
comparing the two groups in terms of spiritual well-being scores.Three-Factor Spiritual Well-Being Scale will use for collecting data.The scale is graded on a 5-point Likert scale (1=Not at all appropriate for me, 2=Not appropriate for me, 3=A little appropriate for me, 4=Quite appropriate for me, 5=Exactly appropriate for me). . An increase in the score obtained from the scale indicates an increase in the spiritual well-being of the individual
Measured: before education, after education, 4 weeks after education
health anxiety scores
comparison of the two groups in terms of health anxiety scores.Health Anxiety Inventory will use for data collecting.. It is an 18-item self-report inventory. Each item is scored from 0 to 3 The maximum score that can be obtained from the scale is 54 and higher scores indicate higher levels of HAI
Measured: before education, after education, 4 weeks after education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start25 Dec 2023
- Primary completion20 Jan 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şahika ŞİMŞEK ÇETİNKAYA, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318702
- Sponsor's protocol ID
- 2023-KAEK-180
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Constructivist Learning Model Based Gynecological Cancer Education on Gynecologic Cancer Awareness, Spiritual Well-being and Health Anxiety: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06318702
- Acronym / sponsor ID
- 2023-KAEK-180
- Conditions
- Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 25 Dec 2023 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 19 Mar 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.
This is a randomised controlled study.The study was conducted to determine the effect of the constructivist education model given to women on gynecological cancer awareness, health Anxiety and spiritual well-being in women . The study population was composed of women living in Kastamonu. Women will be assigned to control and experimental groups. Women in the control group will receive gynecological education from Cancer Early Diagnosis, Screening and Education Centers (KETEM). The other group will receive gynecological cancer education based on the constructivist model.The hypotheses of the study are as follows:
H0: The of constructivist learning model -based health education programme does not have an effect on gynecologic cancer awareness, spiritual well-being and health anxiety.
H1: The of constructivist learning model -based health education programme have an effect on gynecologic cancer awareness, spiritual well-being and health anxiety.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KETEM | No intervention | –This group was given a three-week standard gynecological cancer education program by the Cancer Early Diagnosis, Screening and Education Centers (KETEM) unit. |
| constructivist model group | Experimental | Other: EducationGynecologic cancer education was given to the intervention group for 3 weeks based on the constructivist education model, taking into account the assimilation, adaptation and balancing stages of education. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- being 18 years old,
- being willing to participate in this study
Key exclusion criteria (4 listed)
- having any neuropsychiatric disorder,
- having any physical or mental illness,
- being diagnosed with gynecological cancer,
- not attending theoretical trainings.
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 |
|---|---|---|
| Educationis an education program implemented to raise women's awareness about reproductive health and to help them adopt healthy habits. | Other | constructivist model group |
Primary outcome
gynecologic cancer awareness
Time frame: before education, after education, 4 weeks after education
comparing the two groups in terms of gynecologic cancer awareness scores. Gynaecological cancer awareness scale will use for data collecting. This scale consists of 41 items and four sub-dimensions, with a minimum score of 41 and a maximum score of 205.The awareness of women is greater the higher the scores obtained from the scale.
spiritual well-being
Time frame: before education, after education, 4 weeks after education
comparing the two groups in terms of spiritual well-being scores.Three-Factor Spiritual Well-Being Scale will use for collecting data.The scale is graded on a 5-point Likert scale (1=Not at all appropriate for me, 2=Not appropriate for me, 3=A little appropriate for me, 4=Quite appropriate for me, 5=Exactly appropriate for me). . An increase in the score obtained from the scale indicates an increase in the spiritual well-being of the individual
health anxiety scores
Time frame: before education, after education, 4 weeks after education
comparison of the two groups in terms of health anxiety scores.Health Anxiety Inventory will use for data collecting.. It is an 18-item self-report inventory. Each item is scored from 0 to 3 The maximum score that can be obtained from the scale is 54 and higher scores indicate higher levels of HAI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Gynecologic Cancer
RecruitingPhase 2
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
Recruiting
INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study
Breast Cancer, Corpus Uteri Cancer
Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
Non Small Cell Lung Cancer, Melanoma (Skin Cancer)
Enrolling by invitation
Peer Ambassador in Gyn Onc Trials
Ovarian Cancer
RecruitingObservational study
Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study
Malignant Digestive System Neoplasm, Malignant Female Reproductive System Neoplasm
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Gynecologic Cancer, run by Kastamonu 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 2 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: finished, as of the sponsor's last update on 20 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gynecologic cancer awareness (time frame: before education, after education, 4 weeks after education). The study lists 3 primary outcomes in all. 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 20 Mar 2024.