- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06903390
Investigation of the Effect of Information on the Empowerment of Cancer Patients Using Question Prompt List: A Mixed Method Study
Brief Summary The goal of this study is to understand how patient empowerment and a Question Prompt List (QPL) can help cancer patients.
The main questions this study aims to answer are:
What are the views of nurses, physicians, and cancer patients on patient empowerment? Does using a Question Prompt List (QPL) improve patient empowerment and reduce anxiety? Researchers will collect qualitative and quantitative data by measuring patient empowerment and anxiety levels.
Who can participate? Cancer patients receiving treatment at Private Anadolu Medical Center Hospital Nurses and physicians working with cancer patients What will participants do? Answer survey questions about their experiences with empowerment, anxiety, and communication Participate in interviews to share their thoughts on patient empowerment Use a Question Prompt List (QPL) during medical consultations Why is this study important? Many cancer patients struggle with anxiety and lack of information about their care.
A Question Prompt List (QPL) may help patients ask better questions, feel more in control of their treatment, and reduce anxiety.
This study will contribute to oncology research and help develop a culture-specific QPL for use in cancer care.
This study will take place at Private Anadolu Medical Center Hospital from January 2023 to November 2024.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kadıköy
-
Istanbul, Kadıköy, Turkey (Türkiye), 34722
- Marmara Üniversitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients must be over 18 years old.
- Must understand and speak Turkish.
- Must not have any condition preventing participation (e.g., advanced dementia, cognitive impairment, speech or hearing disorders).
- For healthcare professionals in the qualitative phase: Must have at least one year of experience in oncology.
Exclusion Criteria:
- Patients without regular outpatient follow-up visits.
- Patients with severe cognitive or physiological deterioration affecting participation.
- Patients who do not comply with the study process and requirements.
- Patients who voluntarily request to withdraw from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: "QPL vs. standard care to assess impact on patient empowerment & anxiety in cancer patients.
Experimental Group 1 (QPL Communication Intervention Group) Participants in this group will receive a structured communication intervention using the Quick Question List (QPL) during their oncology examinations. The QPL aims to enhance patient empowerment, encourage active participation, and improve communication between patients and healthcare providers. It is designed to help patients express their concerns effectively and engage more actively in their care process. Intervention: Implementation of a QPL-based communication strategy in addition to standard oncology care. |
This QPL-based communication intervention stands out with the following key features: Patient-Centered & Cancer-Specific QPL: The intervention uses a QPL tailored for cancer patients, culturally adapted to enhance empowerment and manage anxiety. Structured Training & Support: Patients receive training before consultations, with additional guidance for effective QPL use at subsequent visits. Multiple Assessment Points: The QPL's impact is measured after the first, second, and third consultations, allowing for longitudinal evaluation. RCT Design: This study is a randomized controlled trial (RCT), comparing the intervention group (QPL) to a control group receiving standard care. Focus on Empowerment & Anxiety: Unlike prior studies, this intervention focuses on empowering patients and reducing anxiety, with outcomes measured through validated scales (Patient Empowerment Scale and HADS). These features differentiate this intervention by offering a structured, culturally relevant approach. |
|
No Intervention: Standard Care Group
Participants in this group will receive standard physician-patient communication without any additional intervention. This group serves as a control group to evaluate the effectiveness of the QPL-based communication intervention. Intervention: No additional communication tools or interventions will be applied. Patients will receive routine oncology consultations with standard physician-patient interactions. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Patient Empowerment Score
Time Frame: Immediately before the first consultation and within 1 day after the second and third consultations
|
Assessed using the Patient Empowerment Scale to evaluate the effect of QPL-based communication on patient empowerment compared to standard communication.
Higher scores indicate greater empowerment.
|
Immediately before the first consultation and within 1 day after the second and third consultations
|
|
Change in Anxiety Level (HADS)
Time Frame: Immediately before the first consultation and within 1 day after the second and third consultations
|
Measured using the Hospital Anxiety and Depression Scale (HADS) to assess changes in anxiety levels resulting from QPL-based communication versus standard communication.
Lower scores indicate lower anxiety.
|
Immediately before the first consultation and within 1 day after the second and third consultations
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2022.953
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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