Trial Title:
Tele-nursing Practices Based on Technological Competence Theory in Breast Cancer Patients
NCT ID:
NCT05998655
Condition:
Breast Cancer Female
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Tele-nursing
Technological Competence Theory
Breast Cancer
Cancer Empowerment
Symptom Management
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomization will be made on a day-by-day basis due to the possibility of patients
interacting in the outpatient clinic and waiting room during the research process. Before
starting the research, a coin will be tossed to determine which group will be included on
which day. If the money comes in summer, the patients who come on the first day will be
taken to the experimental group, the patients who come on the second day will be taken to
the control group. In the case of heads, the patients who come on the first day will be
included in the control group, and the patients who come on the second day will be
included in the experimental group.
Primary purpose:
Supportive Care
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
In the data collection process, double-blindness will be ensured by not specifying which
group the interviewer collects data from and which group the participants are from.
Intervention:
Intervention type:
Other
Intervention name:
tele nursing
Description:
In the research, tele-nursing applications based on technological competence theory will
be applied to the experimental group. In the content of the application, training,
consultancy and follow-up will be made on breast cancer, the problems experienced in the
treatment process of breast cancer, the most frequently experienced chemotherapy symptoms
and management strategies. Technology knowledge will be based on the concepts of
collaborative design and participant interaction. A five-week group training will be
implemented once a week. The training will be applied to all the participants in the
experimental group and will be held over "Google Meet". Educational program; pre-prepared
powerpoint presentations, oral narration, discussion and group training will be made
using e-booklets.
Arm group label:
experimental group
Summary:
This research is a randomized controlled double-blind experimental study aiming to
evaluate the effect of tele-nursing practices based on technological competence theory on
empowerment status and symptom management self-efficacy in breast cancer patients. The
research will be carried out between September 2023 and March 2024 with patients
diagnosed with breast cancer, who are receiving chemotherapy on an active basis,
registered in the Medical Oncology Polyclinic of Atatürk University Health Research and
Application Center. The sample of the study will consist of 70 people, 35 of which are in
the experimental group and 35 in the control group. Afterwards, approximately 11 weeks of
tele-nursing practices, including training, counseling and tele-monitoring based on the
theory of technological competence, will be given to the experimental group. While
preparing the content of tele-nursing practices, national and international literature
will be scanned. In line with the literature; Training, consultancy and follow-up will be
provided on breast cancer, problems experienced in the treatment process of breast
cancer, the most frequently experienced chemotherapy symptoms and management strategies.
Before starting the training program, a training booklet will be distributed to the
patients and shared as an e-booklet. Within the scope of the training program, a
five-week training will be held once a week via "Google Meet". After the training program
is completed, the counseling and telemonitoring process will begin. In this process, a
previously prepared consultancy guide will be used. Counseling and telemonitoring will
cover 2 chemotherapy cycles (approximately 6 weeks). Within the scope of the application,
the entire experimental group will be individually phoned on the 7th day after receiving
a chemotherapy course. Information about the individual conditions of the patients and
the instant status changes regarding the symptoms will be obtained and their questions
will be answered in line with the previously created counseling guide. Patients will be
informed that at any time other than the specified days, the questions of the patients
regarding the instantaneous situation changes will be answered. After the completion of
the tele-nursing practices, post-test measurements will be made with the Cancer
Empowerment Scale and the Chemotherapy Symptom Management in Breast Cancer-Self-efficacy
Scale of the experimental and control groups, and the feedback of the patients in the
experimental group regarding the implementation process will be received. No attempt will
be made to the individuals in the control group during the research process.
Keywords: Tele-nursing, Technological Competence Theory, Breast Cancer, Cancer
Empowerment, Symptom Management
Detailed description:
Breast cancer is the most common type of cancer in women globally. This situation is
similar in our country and it is seen that one out of every four women diagnosed with
cancer has breast cancer. Breast cancer is curable with 90% or higher survival rates,
especially in the early stages of the disease. As treatment options, chemotherapy,
radiotherapy, immunotherapy and surgical methods are used. These methods are applied in
different combinations according to the stage and biological subtype of breast cancer.
Chemotherapy, which is a frequently used treatment method in cancer treatment, is a
systemic treatment method that aims to destroy cancer cells and stop their uncontrolled
division. On the other hand, chemotherapy has many negative side effects and causes many
physical and emotional symptoms. However, these symptoms can be prevented or reduced with
effective treatment and nursing interventions. There are some skills expected from
patients in order for the applied treatments and interventions to be effective. Among
these skills are; Skills such as symptom management, lifestyle management or coping with
the psychological effects of diseases can also be defined as self-management skills. At
the stage of gaining these skills, the concept of empowerment of cancer patients emerges.
Cancer enhancement; It is a process in which patients specialize in treatment, care and
diseases. Empowerment also provides access to high-quality and appropriate care, improved
quality of life, better interaction with healthcare professionals, better response to
treatment, prevention of complications, and positive attitude towards illness. An
empowered patient is an informed patient who takes responsibility for his or her health
as much as possible. The vast majority of patients receiving neoadjuvant chemotherapy
receive chemotherapy on an outpatient basis. This causes symptoms to be self-managed at
home for a long period of time. On the other hand, breast cancer is subjective and every
person experiences it differently, and responses to the disease and treatment differ
individually. For this reason, it is important to provide individual counseling and
professional support in the process of coping with the side effects of chemotherapy. With
the development of technology, it is necessary to ensure a harmonious coexistence between
nursing care and technology. The theory of 'Technological Competence in Nursing Care',
which was developed based on these requirements, is one of the relatively new nursing
theories and models. According to the theory, the aim of technological competence in
nursing; accepting the patient as a focal point of nursing and benefiting from various
technological tools in nursing interventions and defining the individual. According to
the International Nurses Association (ICN), tele-nursing; According to the American
Nurses Association (ANA), it is defined as the use of communication technologies in
nursing to improve patient care, and nursing practices such as obtaining information
about the health status of patients, providing care, and patient education by using
communication technologies. In this context, tele-nursing is compatible with the concepts
and assumptions of the technological competence theory. Women with breast cancer
experience numerous physical, psycho-social and sexual complications arising from the
disease and treatment methods, and many roles of women are damaged due to the disease.
Symptoms experienced during and after chemotherapy treatment negatively affect the
patient's empowerment and symptom management. In this process, patients often refer to
internet resources to get information about the disease and the symptoms experienced.
However, there are doubts about the accuracy of the information obtained and the level of
evidence. In a study conducted with people with breast cancer, it was determined that
sometimes the information obtained from different internet sources is incomplete or even
inconsistent, causing confusion. In another study, it was determined that people with
breast cancer think that empowerment is important during the illness and that empowerment
issues should include knowledge, beliefs and skills. In this context, it is thought that
tele-nursing practices based on technological competence theory will increase empowerment
in breast cancer patients and benefit the symptom management self-efficacy. Breast cancer
patients are involved in a long and difficult life process from diagnosis. After the
shock process of being diagnosed with cancer, it is necessary to be involved in a
treatment process quickly. Due to some side effects experienced during the treatment
process, they experience some physical, psychological, sexual, occupational and many more
problems. While these problems may improve from time to time, there may also be
exacerbations. In fact, some adaptation problems may be experienced in the process and
patients may even consider stopping the treatment due to the symptoms they experience. In
this context, individual counseling and professional support to be provided to patients
is very important for the effectiveness of the treatment, which must be continued in a
long and difficult process. In a systematic review study evaluating the effectiveness of
nursing interventions for breast cancer patients according to the literature, it was
determined that nurse-led teaching, guidance, counseling and case management
interventions were effective for symptom management. On the other hand, it has been found
that the symptom management of patients is poorly controlled despite various guidance in
different studies. For this reason, new studies with different models are required in
order to provide management skills more powerfully. The concept of patient empowerment is
growing in importance in health-related research, and studies show that empowerment
improves care outcomes and increases patient satisfaction in those with chronic illness.
Thanks to the advances in early diagnosis and treatment technology of breast cancer,
survival rates have increased and it has started to be seen as a chronic disease. In most
of the studies on the subject, it is seen that augmentation-related interventions are
effective, but generally work with breast cancer survivors. However, the fact that the
population defined as breast cancer survivors, that is, who completed the breast cancer
treatment process, has more experience compared to their newly diagnosed peers and
partially knew what to do and how to do it, suggests that they may need an information
tool less. In this context, breast cancer patients should be informed about their disease
throughout their lives and during the chemotherapy process in order to strengthen their
symptom management skills while their treatment continues. When the literature is
evaluated, it is seen that information studies conducted with breast cancer patients
receiving chemotherapy are generally conducted in the outpatient chemotherapy unit, even
while the patient is receiving chemotherapy drugs. In this process, it is thought that
breast cancer patients are in the hospital environment and in a crowded environment, they
experience the early side effects of the treatment intensely, they have difficulty in
managing the symptoms they experience at home and in reaching adequate counseling and
support when they need it, and for this reason, they cannot fully benefit from the
information/education studies. For this reason, it is expected that informing the patient
with tele-nursing practices while the patient is at home during the periods when the
patients feel better and the early side effects of chemotherapy decrease, and until the
next cure treatment will contribute both in terms of the patient and the skill
development expected from the patient. There are some studies evaluating the effects of
web-based and mobile application interventions in breast cancer patients. It has been
found that the applications made in these studies provide clinical improvement in
conditions such as symptom control and management, self-management behaviors, functional
exercise compliance, quality of life and drug compliance. No study has been found that
evaluates the effects of tele-nursing practice, which is based on technological
competence theory and focuses on self-efficacy, especially on empowerment and symptom
management, in breast cancer patients receiving neoadjuvant chemotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Breast cancer I., II. or III. in phase
- Without organ metastases
- Those who have not been diagnosed with any other cancer other than breast cancer
- Literate
- Receiving neoadjuvant chemotherapy
- Received at least 1 course of chemotherapy
- Those who does not have hearing and speech problems that will prevent talking on the
phone
- Capable of using a smartphone
- Does not have any psychiatric problems that reduce the ability to understand
- Who volunteered to participate in the research
Exclusion Criteria:
- With stage 4 breast cancer
- Organ metastases
- Those who have been diagnosed with a cancer other than breast cancer
- iliterate
- Cannot communicate verbally
- Unable to use a smartphone
- No internet connection or online access
- Who refused to participate in the research
Gender:
Female
Gender based:
Yes
Gender description:
Breast cancer in women
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ataturk University
Address:
City:
Erzurum
Zip:
25240
Country:
Turkey
Status:
Recruiting
Investigator:
Last name:
Elanur YILMAZ KARABULUTLU
Email:
Principal Investigator
Start date:
September 1, 2023
Completion date:
May 2024
Lead sponsor:
Agency:
Ataturk University
Agency class:
Other
Source:
Ataturk University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05998655
