Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05992441 |
| Other study ID # |
E-10840098-772.02-205 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 23, 2023 |
| Est. completion date |
December 15, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Fenerbahce University |
| Contact |
Nergis Yilmaz, licence |
| Phone |
5318549782 |
| Email |
nergis-yilmaz39[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
