The Impact of a Web-based Empowerment Program on Intolerance of Uncertainty and Maintenance Burden.

June 19, 2026 updated by: Kübra Nur KÖSE ALABAY, Necmettin Erbakan University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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,
  • 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.

Exclusion Criteria:

  • Caregivers whose patients are receiving chemotherapy will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Strengthening Program Group
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
Other: Web-Based Empowerment Program Based on Uncertainty Theory
Web-Based Empowerment Program Based on Uncertainty Theory
No Intervention: Control
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
first week and fifteenth week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Zarit Caregiver Burden Scale
Time Frame: first week and fifteenth week
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.
first week and fifteenth week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Necmettin Erbakan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 12, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 17, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Nec Erbakan U

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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