NCT05825287

Brief Summary

.The aim of this study is to evaluate the effectiveness of the education method given by using the documents shaped by the teach-back method in the management of the frequently encountered side effects in chemotherapy treatment and to develop an effective method that health professionals can use in patient education.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

Same day

First QC Date

March 30, 2023

Last Update Submit

September 23, 2025

Conditions

Keywords

Teach-BackLife qualitychemotherapy side effects

Outcome Measures

Primary Outcomes (2)

  • Edmonton Symptom Diagnosis Scale will be used to determine the effect of patient education given by the teack-back method on the management of symptoms between successive chemotherapy sessions.

    In the Edmonton Symptom Diagnostic Scale, various symptoms such as pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, feeling well, shortness of breath, changes in the skin and nails, wounds in the mouth, numbness in the hands and other problems are questioned. The person completing the scale evaluates his/her own situation with a score between 0 and 10. 0 denotes the best case, 10 denotes the worst case.

    Average 1 year

  • The EQ-5D Quality of life scale will be used to determine the effect of patient education given by the teack-back method on the quality of life between consecutive chemotherapy sessions.

    The EQ-5D is a self-report scale developed by the EuroQoL group, the Western European quality of life research community. It consists of two parts. Chapter 1 defines the health profile in 5 dimensions. (mobility, self-care, usual daily activities, pain/discomfort, and anxiety/depression) Each dimension includes 3 statements according to difficulty level. (1 some problem, 2 moderate, 3 a lot of problems) Section 2 includes the visual analog scale (VAS), in which respondents rate their current health status on a scale of 0 to 100. It is easy to apply and is completed in a short time.

    Average 1 year

Study Arms (2)

Trained by teaching back method

ACTIVE COMPARATOR

The course method will determine which group to assign the first patient to meet the criteria for inclusion in the study by the researcher. Subsequent patients will be distributed to groups in turn. It is planned to include 40 participants in the study, as losses may occur among the participants. The study will begin on the day that cancer-treated participants receive chemotherapy for the first time. Considering that the participants would be more comfortable and the training would be healthy, the training was planned 30 minutes before the application. The training was planned by the researcher in the chemotherapy case manager's room as face-to-face meetings with each participant separately. Each training will be accompanied by a chemotherapy case manager. Training time is between 20-30 minutes as planned.

Other: Trained by teaching back method

Management training

EXPERIMENTAL

The course method will determine which group to assign the first patient to meet the criteria for inclusion in the study by the researcher. Subsequent patients will be distributed to groups in turn. It is planned to include 40 participants in the study, as losses may occur among the participants. The study will begin on the day that cancer-treated participants receive chemotherapy for the first time. Considering that the participants would be more comfortable and the training would be healthy, the training was planned 30 minutes before the application. The training was planned by the researcher in the chemotherapy case manager's room as face-to-face meetings with each participant separately. Each training will be accompanied by a chemotherapy case manager. Training time is between 20-30 minutes as planned.

Other: Management training

Interventions

in chemotherapy symptom management training, 2 groups will be created and a group will be given normal symptom management training, and the other group will be trained by teaching back method to assess the symptom control and quality of life after the chemotherapy training that patients have received and evaluate the effect of the teaching back method

Trained by teaching back method

Management training

Management training

Eligibility Criteria

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

You may qualify if:

  • First time chemotherapy,
  • Patients over 18 years old
  • Patients agree to participate in research
  • Knowing and understanding Turkish
  • IV and oral chemotherapy treatment
  • Lack of communication problems and cognitive deficiency

You may not qualify if:

  • He has been treated for chemotherapy before
  • To receive radiation therapy with chemotherapy treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ozel Anadolu Sağlik Merkezi

Kocaeli, 41400, Turkey (Türkiye)

Location

Related Publications (1)

  • Yen PH, Leasure AR. Use and Effectiveness of the Teach-Back Method in Patient Education and Health Outcomes. Fed Pract. 2019 Jun;36(6):284-289.

    PMID: 31258322BACKGROUND

Related Links

MeSH Terms

Conditions

Teach-Back Communication

Interventions

Anger Management Therapy

Condition Hierarchy (Ancestors)

CommunicationBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Bilgi GULSEVEN KARABACAK, doctors

    Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: The model of research is quantitative. Participants are experimental because they are randomly selected to the interference and control group. It is a randomized controlled clinical study, a group of interventions and controls, to determine the impact of the first-time education in patients who have been diagnosed with cancer and have been treated for chemotherapy to manage symptoms and determine the quality of life of patients.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 24, 2023

Study Start

January 1, 2021

Primary Completion

January 1, 2021

Study Completion

December 31, 2024

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

I will not present individual participant data to other researchers.

Locations