Trial Title:
Awareness Scale Related To Physiotherapy After Breast Cancer: A Scale Development Study
NCT ID:
NCT05992441
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast
cancer
physiotherapy
awareness
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
SCALE DEVELOPMENT STUDY
Description:
The study to be carried out is a scale development study. The steps to be followed for
the scale development study are as follows;
1. Creating an item pool by making use of the literature review on the subject,
2. Questioning the relevance of the prepared question pool to the subject to be
measured with the "Expert Evaluation Form" by experts in the field,
3. Pilot application,
4. Switching to the main study after the pilot application,
5. After the factor and item analyzes, the final arrangements regarding the item and
form of the scale will be completed.
As a result of this study, an awareness scale related to physiotherapy will be created
for individuals with breast cancer.
Arm group label:
breast cancer
Summary:
In this study, the aim is to develop a scale that assesses the awareness levels of
particularly short and/or long-term effects, especially related to physiotherapy, in
individuals diagnosed with high incidence and survival rates of breast cancer.
Detailed description:
Regarded as a "wound that never heals," cancer is characterized by the uncontrolled
proliferation of abnormal cells and the abnormal recognition of the immune system. Cancer
is the second leading cause of death worldwide, with an estimated 14.1 million cases and
8.2 million deaths per year. Approximately 1 in 4 deaths in the United States are due to
cancer, however, the cancer burden has increased over time and continues to increase in
both developed and developing countries due to an aging and growing population,
accelerated socioeconomic development, and changes in the prevalence of associated risk
factors.
Breast cancer is the most common malignancy in women and one of the three most common
types of cancer worldwide, along with lung and colon cancer, usually detected either by
screening or by a symptom (for example, pain or a palpable mass) that warrants a
diagnostic examination. Advances in screening and treatment methods enable the diagnosis
of this disease in its early stages. The primary treatment for early-stage breast cancer
is surgery with adjuvant treatments such as chemotherapy, radiotherapy and endocrine
therapy. However, these treatments also cause side effects such as pain, fatigue and
sleep disorders. Such effects can significantly worsen the patient's health-related
quality of life, especially in the immediate post-operative period.
Due to advances in systemic therapies, widely used screening programs, and the high
incidence of breast cancer, the number of women who survive breast cancer is constantly
increasing. Many of these women have multiple, complex and unique healthcare needs. Women
who have completed their treatment have difficulty returning to their normal lives, often
feel 'abandoned' and report that their health care needs are not adequately met. This is
among the important problems affecting the lives of breast cancer survivors and their
families.
The most important problems encountered at the end of breast cancer treatment are
cardiotoxicity, pain, fatigue, lymphedema, cognitive impairment, early menopause,
distress, depression and anxiety, neuropathy, infertility, musculoskeletal system
problems, and osteoporosis. It is especially important to take precautions against such
effects, as the survival rate is increasing.
Although physical activity is often used as an adjunctive therapy to alleviate disease
and treatment-related symptoms during chemotherapy and radiotherapy, its effects such as
improvement in patients' physical function, vitality, strength and quality of life,
reduced risk of developing lymphedema, decreased depression, fatigue and pain, and
reduced psychological complaints cannot be ignored, physical activity is also associated
with a reduced risk of relapse and a better survival. Exercise programs have also been
shown to improve mental health-related quality of life among breast cancer survivors who
have completed cancer treatment.
Exercise is an effective non-pharmacological method to reduce the deleterious effects of
breast cancer treatments on cardiovascular health, by modifying cardiovascular risk
factors and potentially reducing cardiovascular morbidity and mortality in this
vulnerable population.
In a study evaluating quality of life, quality of supportive care services, and perceived
safety against 18 potential cancer-related health problems among young women under
follow-up after cancer diagnosis, breast cancer survivors reported significantly worse
quality of life among different types of cancer. In the study, it was concluded that
although 78% of the post-cancer survivors were willing to know about the treatment and
the late effects of cancer, only 36% of the people received information about these
effects.
In the study, which was conducted to determine the continuing needs and concerns of women
over the years by interviewing individuals with breast cancer treated with radiotherapy,
very few women reported that despite advances in cancer care services and advances in
patient-centered care, they were informed about some of the potential outcomes of
radiotherapy in addition to treatment procedures, and that they were not warned against
common late effects such as ongoing fatigue and pain.
In a study conducted to determine the knowledge and awareness of colorectal cancer
survivors about the long-term and late-term consequences of treatment, it was revealed
that the participants were not aware of the risks of complications other than recurrence.
Some of the participants noted how things might change after surgery, that other aspects
of their treatment were less well explained, while others said they were unsure whether
their current symptoms were cancer-related and wanted to be warned about some of the
things the process might affect before they experienced it.
In the study, which aimed to determine the level of awareness of lymphedema related to
breast cancer in women with breast cancer in the Kingdom of Saudi Arabia, an online
questionnaire was distributed and data were collected. In addition, it was concluded that
the level of awareness and quality of life were related.
It has been demonstrated that there is a need for the development of an early education
program on the possibility of developing lymphedema in women who have undergone breast
cancer surgery and who have received chemotherapy or radiotherapy, and customized
educational interventions using different materials to improve knowledge, perception and
awareness about tumor and treatment outcomes. Early diagnosis is important in order to
improve the quality of life of patients and to achieve a better outcome in women with
breast cancer, and for this reason, it is necessary to determine and increase the
awareness level of patients. In addition, since there is a serious relationship between
the awareness level of women with breast cancer and their improvement in their quality of
life, it has been reported that future studies should investigate the relationship
between the awareness level of lymphedema and improving the quality of life of women with
breast cancer. As far as we know, subjective questions were used while evaluating the
effects and awareness of these effects in individuals with breast cancer in previous
studies, and there is no scale developed and used for this purpose.
In this direction, the aim of this study is to develop a scale that evaluates the
awareness levels of individuals diagnosed with breast cancer with a high incidence and
survival, especially for the effects that may occur in the short and/or long term,
especially physiotherapy-related effects. At the same time, it is planned to use the
quality of life parameter, which has been proven to be related to the level of awareness,
in determining the content validity of this developed scale.
The participant group of this research will consist of women diagnosed with breast
cancer, and participation will be based on a voluntary basis.
The first step for the scale development study is to create an item pool by utilizing a
literature review on the designated topic. After the item pool is created, experts from
the relevant field will be selected, and the items prepared with the "Expert Evaluation
Form" will be assessed for their relevance to the intended measurement topic. After the
expert evaluation, the Content Validity Ratio will be calculated to determine whether the
items should be removed from or retained in the scale, and for the entire test, the
Content Validity Index will be obtained. Subsequently, the preparation stage of the
measurement tool will be initiated. In this stage, a scale guideline will be written,
items will be placed within the test, and the format of scale options will be determined.
Once the scale has obtained approval from the expert group, a pilot test will be
conducted on a small sample group to assess its performance. Item analysis using relevant
statistical methods will be conducted for the initial pilot application. After these
steps, the scale will reach its final form.
Following the finalization of the scale, a sample group representing the target
population will be determined, along with the appropriate sample size. The sample size
will be selected to be 5-10 times the number of items in the final scale, as recommended.
After determining the sample group size, the application of the scale to the relevant
group within the research scope will take place. Following the administration, an
evaluation of the items and a preliminary examination of their performance will be
conducted. This stage includes statistical calculations such as item-total correlations,
item variances, and item means. In the subsequent stage after factor and item analysis,
if necessary, final adjustments will be made regarding the content and format of the
scale. By following these steps, the process of scale development will be completed.
To assess the awareness levels of individuals regarding the effects of cancer treatments,
particularly related to physiotherapy, a pool of 50 questions was created based on
relevant guidelines from the International Cancer Institute, American Cancer Society, and
American Society of Clinical Oncology. These questions were formulated considering the
potential effects that may occur in any period after the treatment. Additionally, the
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire
(EORTC QLQ-C30) and the EORTC QLQ-BR23, specific to breast cancer, will be used for the
criterion validity of the developed scale.
Criteria for eligibility:
Study pop:
The participant group of this research will consist of women aged 18 and over who have
been diagnosed with breast cancer, and participation will be on a voluntary basis.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Be over 18 years old
- Be woman
- Being diagnosed with breast cancer (individuals diagnosed with breast cancer who
will start, start or have completed breast cancer treatment)
- Being able to read and understand the Turkish language
Exclusion Criteria:
- Having a cognitive impairment that interferes with answering questions
- Be man
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Fenerbahce Unıversty
Address:
City:
Istanbul
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
nergis yılmaz
Email:
nergis-yilmaz39@hotmail.com
Start date:
April 23, 2023
Completion date:
December 15, 2023
Lead sponsor:
Agency:
Fenerbahce University
Agency class:
Other
Source:
Fenerbahce University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05992441
