Clinical trial NCT05393947: Investigation of the Effect of Education on Symptom Management on Symptom Management in Patients With Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Symptom management
timeFrame: 3 weeks
Secondary outcomes:
measure: Nightingale Symptom Assessment Scale
timeFrame: 3 weeks
measure: Self-Care Behaviors Inquiry Form
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Saglik Bilimleri Universitesi
Study officials:
affiliation: İstanbul Health Sciences University
name: Dilek URTEKİN
role: PRINCIPAL_INVESTIGATOR
References: