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

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: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: patient education

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dilek Urtekin; Phone Number: +905464046211; Email: dilekurtekin@hotmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Saglik Bilimleri Universitesi
    • Contact: Dilek Urtekin; Phone Number: 05464046211; Email: dilekurtekin@hotmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Symptom management	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

Outcome Measure	Measure Description	Time Frame
Nightingale Symptom Assessment Scale	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	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

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Principal Investigator: Dilek URTEKİN, Istanbul Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID 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