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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

62

Phase

  • 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

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

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
Intervention / Treatment
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

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

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

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)

July 1, 2026

Primary Completion (Estimated)

April 12, 2027

Study Completion (Estimated)

May 17, 2027

Study Registration Dates

First Submitted

June 19, 2026

First Submitted That Met QC Criteria

June 19, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID 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.

Subscribe