Investigation of the Effect of Education on Symptom Management on Symptom Management in Patients With Breast Cancer

November 3, 2022 updated by: Dilek Urtekin, Saglik Bilimleri Universitesi

Investigation of the Effect of the Training Given According to Orem's Self-Care Deficit Theory Based Education on the Management of Chemotherapy Side Effects and Improving the Patient's Self-Care of the Patients With Breast Cancer

It is used with different treatment options such as chemotherapy, radiotherapy and surgery in the treatment of breast cancer, which is common in women among all cancers in the world. Side effects such as nausea, vomiting, neuropathy, oral nucositis, constipation, sleep problems, fatigue and alopecia occur due to chemotherapeutic agents applied in the treatment of breast cancer. Due to the lack of information and side effects related to cancer treatment, it negatively affects the adherence to treatment and self-care power of individuals. In this study, it was planned to examine the effect of training given for chemotherapy-related symptoms on self-care power and the management of chemotherapy side effects. Your study was planned as a single-center, randomized controlled quasi-experimental design. The research sample will consist of breast cancer patients aged between 18 and 65 years who were treated at Tekirdağ Namık Kemal University Hospital between July 2022 and April 2023 and accepted to participate in the study [26 intervention (experimental) group - 26 control group]. Intervention and control groups will be determined by using the random numbers table from the simple random sampling method, which is one of the probability sampling methods. In line with Orem's Self-Care Deficit Theory, a training booklet will be created for the management of chemotherapy side effects. Participants in the intervention (experimental) group of the study will be given training on chemotherapy side effects, which lasts 20-30 minutes at the first interview. Patient Information Form, Nightingale Symptom Evaluation Scale and Self-Care Behaviors Inquiry Form will be filled. Patients will be followed up for a total of 5 times during 4 cycles of chemotherapy and will be interviewed face-to-face at each chemotherapy cycle. Data collection tools will be filled in face-to-face interviews, the patient's side effects due to chemotherapy and the methods applied in the face of these side effects will be questioned, suggestions will be given for the control of chemotherapy side effects, and the patient's questions will be answered. No intervention will be applied to the participants in the control group of the study. In this study, it is thought that education and follow-up based on Orem's Self-Care Deficit Theory will contribute to the development of self-care behaviors and effective side-effect management in patients receiving chemotherapy for breast cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

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 (Anticipated)

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.
52

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.

Study Locations

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Receiving adjuvant chemotherapy with the diagnosis of breast cancer,
  • Receiving CE (cyclophosphamide-epirubicin) or CA (cyclophosphamide-adriamycin) treatment protocol,
  • First time receiving chemotherapy,
  • Aged between ≥ 18 and ≤ 65,
  • Can understand Turkish and can read and write,
  • Those whose health status is suitable for participating in the research,
  • Having stage I, stage II and stage III breast cancer,
  • Identified as patients who volunteered to participate in the study

Exclusion Criteria:

  • Metastasis detected
  • Those with a diagnosis of psychiatric disease
  • Those who want to leave the research and
  • Patients whose general condition deteriorates will not be included in the study.

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: patient aducation
It is planned to provide education to patients about the side effects of chemotherapy.
Other: patient education
It is planned to provide education to patients about the side effects of chemotherapy.
No Intervention: observation
While training the patients in the intervention group, observations will be made on the patients in the experimental group.

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
Symptom management
Time Frame: 3 weeks
A training booklet on the management of chemotherapy side effects was prepared for the intervention (experimental) group of the study, based on Orem's Self-Care Disability Theory. Before the first chemotherapy course, a training was given in parallel with the training booklet. The training booklet was given to the patients. This training and education booklet contributed to the management of chemotherapy-related side effects and the development of self-care behaviors in individuals with breast cancer at the end of 4 chemotherapy cycles.
3 weeks

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
Nightingale Symptom Assessment Scale
Time Frame: 3 weeks
The Nightingale Symptom Assessment Scale is a quality of life scale developed for cancer patients. It measures the level of being affected by the disease/treatment-related problems of the patients. This scale was scored as "0" if the patient's response to the item being evaluated was no, and "4" if it was too much. O point stated that the quality of life was not affected at all, and 4 points stated that it was greatly affected.
3 weeks
Self-Care Behaviors Inquiry Form
Time Frame: 3 weeks
The Self-Care Behaviors Inquiry Form was prepared by the researchers in order to question the individual's self-care behaviors. The form consists of questions about the patient's daily life self-care behaviors related to chemotherapy-induced nausea-vomiting, changes in taste and smell, oral mucositis, diarrhea, constipation, fatigue, sleep problems and alopecia. This form was applied in the form of individuals answering the statements themselves. Response options were answered with 0 points for the answer "I never apply" and 3 points for the answer "I always apply". High scores showed that the patient's self-care behaviors improved positively.
3 weeks

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.
Saglik Bilimleri Universitesi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dilek URTEKİN, Istanbul Health Sciences 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 (Actual)

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, 2022

Primary Completion (Anticipated)

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.
December 1, 2022

Study Completion (Anticipated)

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.
April 1, 2023

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).
May 18, 2022

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.
May 23, 2022

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.
May 26, 2022

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.
November 8, 2022

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.
November 3, 2022

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.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • SaglikBilimleriU_DU

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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