Intolerance of UncertaintyNCT07668427
The Impact of a Web-based Empowerment Program on Intolerance of Uncertainty and Maintenance Burden.
A study testing Web-Based Empowerment Program Based on Uncertainty Theory in people with Intolerance of Uncertainty and Caregiving Burden, run by Necmettin Erbakan University.
Trial summary
The aim of this study is to examine the relationship between uncertainty intolerance and caregiver burden in a web-based empowerment program based on uncertainty theory in disease, applied to caregivers of prostate cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intolerance of Uncertainty, Caregiving Burden
- What is being tested?
- Web-Based Empowerment Program Based on Uncertainty Theory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 17 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age,
- Able to speak Turkish,
- Literate,
- No hearing or vision problems,
- No neurological and/or psychiatric disorders,
- Physical and cognitive health levels suitable for answering the forms used in the study,
Show all 12Show fewer
- Having a patient diagnosed with prostate cancer,
- Being the primary caregiver responsible for meeting the patient's care needs (home care, supervision, hospital check-ups, etc.) within the family,
- Having a patient scheduled for hormone therapy and radiotherapy,
- Not having undergone prostatectomy,
- Having an electronic device such as a smartphone or computer with internet access, either themselves or a family member,
- Caregivers of prostate cancer who volunteer to participate in the study will be included.
Who cannot join
- Caregivers whose patients are receiving chemotherapy will be excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of a Web-Based Empowerment Program Based on the Theory of Illness Applied to Caregivers of Prostate Cancer Patients on Intolerance of Uncertainty and Caregiver Burden: A Randomized Controlled Trial
The aim of this study is to examine the relationship between uncertainty intolerance and caregiver burden in a web-based empowerment program based on uncertainty theory in disease, applied to caregivers of prostate cancer patients.
Read the detailed description
This study was designed as a pre-test-post-test parallel-group, randomized controlled experimental design. The research will be conducted at the Radiation Oncology Clinic of Necmettin Erbakan University Faculty of Medicine Hospital, Republic of Turkey. Caregivers of prostate cancer patients will be randomly divided into two groups: experimental group (31) and control group (31). For the experimental group: A web-based reinforcement program based on uncertainty theory will be applied. For the control group: No application will be made to the caregivers. The primary outcome of this study is to determine the intolerance to uncertainty scores of caregivers of prostate cancer patients. The secondary outcome is to determine the caregiving burden of caregivers.
- Conditions
- Intolerance of Uncertainty, Caregiving Burden
- Being tested
- Web-Based Empowerment Program Based on Uncertainty Theory
- Keywords
- Intolerance of uncertainty, caregiving burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Empowerment Program Based on Uncertainty TheoryOther
Web-Based Empowerment Program Based on Uncertainty Theory
| Study group | Role | What they receive |
|---|---|---|
| Strengthening Program Group | Experimental | Caregivers will participate in a 15-week Web-Based Caregiver Empowerment Program. In the first week, after completing an informed consent form, caregivers will be introduced to the Web-Based Empowerment Program based on the Theory of Illness. Pre-test forms (Caregiver Information Form, Intolerance of Uncertainty Scale (IUS-12), Zarit Caregiver Burden Scale) will be administered. The program will include two modules of training and five counseling sessions for caregivers. In the second week, caregivers will receive training on Module 1: General Information about Prostate Cancer and Hormone Therapy in Prostate Cancer. In the seventh week, training on Module 2: Radiotherapy in Prostate Cancer will be provided. Counseling sessions will be held in weeks three, five, eight, eleven, and thirteen. During the counseling session, patients' questions regarding the training will be answered. The final test forms (Caregiver Information Form, Intolerance of Uncertainty Scale (IUS-12), Zarit Caregiv Receives: Other: Web-Based Empowerment Program Based on Uncertainty Theory |
| Control | No intervention | Caregivers will not receive any intervention for fifteen weeks. Standard care will be provided. In the first week, caregivers will be administered pre-test forms (Caregiver Information Form, Intolerance of Uncertainty Scale (IUS-12), Zarit Caregiver Burden Scale form). In the fifteenth week, post-test forms (Caregiver Information Form, Intolerance of Uncertainty Scale (IUS-12), Zarit Caregiver Burden Scale form) will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intolerance of Uncertainty Scale
The highest possible score on the scale is 60, and the lowest is 12. Higher scores indicate a high level of intolerance for uncertainty. Higher scores indicate greater intolerance for uncertainty.
Measured: first week and fifteenth week
Secondary outcomes (1)
Zarit Caregiver Burden Scale
The scale can be scored from a minimum of 0 to a maximum of 88 points. A high score on the scale indicates a high caregiver burden.
Measured: first week and fifteenth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion12 Apr 2027 (estimated)
- Study completion17 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intolerance of UncertaintyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Nur KÖSE ALABAY, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668427
- Sponsor's protocol ID
- Nec Erbakan U
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Web-Based Empowerment Program Based on the Theory of Illness Applied to Caregivers of Prostate Cancer Patients on Intolerance of Uncertainty and Caregiver Burden: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07668427
- Acronym / sponsor ID
- Nec Erbakan U
- Conditions
- Intolerance of Uncertainty, Caregiving Burden
- Keywords
- Intolerance of uncertainty, caregiving burden
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 12 Apr 2027 (estimated)
- Study completion
- 17 May 2027 (estimated)
- First posted
- 25 Jun 2026 (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.
The aim of this study is to examine the relationship between uncertainty intolerance and caregiver burden in a web-based empowerment program based on uncertainty theory in disease, applied to caregivers of prostate cancer patients.
Detailed description
This study was designed as a pre-test-post-test parallel-group, randomized controlled experimental design. The research will be conducted at the Radiation Oncology Clinic of Necmettin Erbakan University Faculty of Medicine Hospital, Republic of Turkey. Caregivers of prostate cancer patients will be randomly divided into two groups: experimental group (31) and control group (31). For the experimental group: A web-based reinforcement program based on uncertainty theory will be applied. For the control group: No application will be made to the caregivers. The primary outcome of this study is to determine the intolerance to uncertainty scores of caregivers of prostate cancer patients. The secondary outcome is to determine the caregiving burden of caregivers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Strengthening Program Group | Experimental | Other: Web-Based Empowerment Program Based on Uncertainty TheoryCaregivers will participate in a 15-week Web-Based Caregiver Empowerment Program. In the first week, after completing an informed consent form, caregivers will be introduced to the Web-Based Empowerment Program based on the Theory of Illness. Pre-test forms (Caregiver Information Form, Intolerance of Uncertainty Scale (IUS-12), Zarit Caregiver Burden Scale) will be administered. The program will include two modules of training and five counseling sessions for caregivers. In the second week, caregivers will receive training on Module 1: General Information about Prostate Cancer and Hormone Therapy in Prostate Cancer. In the seventh week, training on Module 2: Radiotherapy in Prostate Cancer will be provided. Counseling sessions will be held in weeks three, five, eight, eleven, and thirteen. During the counseling session, patients' questions regarding the training will be answered. The final test forms (Caregiver Information Form, Intolerance of Uncertainty Scale (IUS-12), Zarit Caregiv |
| Control | No intervention | –Caregivers will not receive any intervention for fifteen weeks. Standard care will be provided. In the first week, caregivers will be administered pre-test forms (Caregiver Information Form, Intolerance of Uncertainty Scale (IUS-12), Zarit Caregiver Burden Scale form). In the fifteenth week, post-test forms (Caregiver Information Form, Intolerance of Uncertainty Scale (IUS-12), Zarit Caregiver Burden Scale form) will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Over 18 years of age,
- Able to speak Turkish,
- Literate,
- No hearing or vision problems,
- No neurological and/or psychiatric disorders,
Key exclusion criteria (1 listed)
- Caregivers whose patients are receiving chemotherapy will be excluded.
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 |
|---|---|---|
| Web-Based Empowerment Program Based on Uncertainty TheoryWeb-Based Empowerment Program Based on Uncertainty Theory | Other | Strengthening Program Group |
Primary outcome
Intolerance of Uncertainty Scale
Time frame: first week and fifteenth week
The highest possible score on the scale is 60, and the lowest is 12. Higher scores indicate a high level of intolerance for uncertainty. Higher scores indicate greater intolerance for uncertainty.
1 secondary outcome
Zarit Caregiver Burden Scale
Time frame: first week and fifteenth week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Intolerance of Uncertainty
Not yet recruiting
Group Transdiagnostic Cognitive Behavioural Therapy for Intolerance of Uncertainty Versus Applied Relaxation
Mental Disorders, Mood Disorders
Active, not recruiting
Effects and Mechanisms of Change of Internet Delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder
Generalized Anxiety Disorder
Recruiting
Test of Target Engagement of Ambiguity Aversion
Intolerance of Uncertainty, Anxiety
Enrolling by invitationObservational study
Measurement of the Intolerance to Uncertainty in Osteopaths
Cognition of Osteopath
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.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Empowerment Program Based on Uncertainty Theory in people with Intolerance of Uncertainty and Caregiving Burden, run by Necmettin Erbakan University.
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 12 inclusion and 1 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: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kübra Nur KÖSE ALABAY (+905544319384, kubranurkosee@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intolerance of Uncertainty Scale (time frame: first week and fifteenth week). 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 25 Jun 2026.