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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
patient education
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Saglik Bilimleri UniversitesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

patient aducation

observation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 18, 2022
Last Updated
November 3, 2022
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05393947
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patient aducation
Arm Type
Experimental
Arm Description
It is planned to provide education to patients about the side effects of chemotherapy.
Arm Title
observation
Arm Type
No Intervention
Arm Description
While training the patients in the intervention group, observations will be made on the patients in the experimental group.
Intervention Type
Other
Intervention Name(s)
patient education
Intervention Description
It is planned to provide education to patients about the side effects of chemotherapy.
Primary Outcome Measure Information:
Title
Symptom management
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Nightingale Symptom Assessment Scale
Description
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.
Time Frame
3 weeks
Title
Self-Care Behaviors Inquiry Form
Description
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.
Time Frame
3 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dilek Urtekin
Phone
+905464046211
Email
dilekurtekin@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek URTEKİN
Organizational Affiliation
İstanbul Health Sciences University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saglik Bilimleri Universitesi
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dilek Urtekin
Phone
05464046211
Email
dilekurtekin@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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