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

NCT05393947 | Unknown

• 1 other identifier: SaglikBilimleriU_DU
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Nightingale Symptom Assessment Scale

  3 weeks

• Self-Care Behaviors Inquiry Form

  3 weeks

Study Arms (2)

patient aducation

EXPERIMENTAL

It is planned to provide education to patients about the side effects of chemotherapy.

Other: patient education

observation

NO INTERVENTION

While training the patients in the intervention group, observations will be made on the patients in the experimental group.

Interventions

patient education OTHER

It is planned to provide education to patients about the side effects of chemotherapy.

patient aducation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Saglik Bilimleri Universitesi

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Dilek URTEKİN

  İstanbul Health Sciences University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek Urtekin

CONTACT

+905464046211; dilekurtekin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 26, 2022
• Study Start: July 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: April 1, 2023
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)