NCT06903390

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
Last Updated

December 10, 2025

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

March 19, 2025

Last Update Submit

December 3, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Patient Empowerment Score

    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)

    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

Study Arms (2)

"QPL vs. standard care to assess impact on patient empowerment & anxiety in cancer patients.

EXPERIMENTAL

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.

Behavioral: QPL-based Communication Intervention

Standard Care Group

NO INTERVENTION

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.

Interventions

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.

"QPL vs. standard care to assess impact on patient empowerment & anxiety in cancer patients.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara Üniversitesi

Istanbul, Kadıköy, 34722, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NeoplasmsPatient ParticipationAnxiety Disorders

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This study follows an open-label design, meaning that participants, care providers, and investigators are aware of the assigned intervention. Masking Description: Since this study involves a communication-based intervention, blinding is not feasible, as both participants and care providers are directly involved in delivering and receiving the intervention.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This study is a parallel-group randomized controlled trial designed to assess the impact of QPL-based communication intervention on patient empowerment and anxiety levels in cancer patients. Participants are assigned to either the intervention group (QPL-based communication) or the control group (standard physician-patient communication).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student, Principal Investigator

Study Record Dates

First Submitted

March 19, 2025

First Posted

March 30, 2025

Study Start

March 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

December 10, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations