Breast Cancer Clinical Trial
Official title:
Relaxation Training By Tele-Rehabilitation Program In Patients With Breast Cancer Receiving Chemotherapy During COVID-19.
Verified date | October 2023 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
With developing treatment methods, oncological rehabilitation has become an important complementary part of cancer treatment. Due to the COVID-19 pandemic, the use of tele-rehabilitation has gained importance in terms of access to physical therapy in individuals with breast cancer. Considering the home environment and the patient profile, it is thought that relaxation exercises can be used in the most comfortable and safe way for patients to reduce the side effects of chemotherapy and can be used as home exercises whose effectiveness has been reported in the literature. The purpose of our study; to examine the effects of relaxation exercises performed by tele-rehabilitation on functional capacity, fatigue, emotional state, quality of life, cognitive status, sleep quality and kinesiophobia in breast cancer patients receiving chemotherapy. A total of 64 patients, will randomly be allocated to the exercise group (n = 32) and to the control group (n = 32). Participants will be evaluated at first appoinment and after 6 weeks of intervention. 'Brief Pain Questionnaire' for assessment of pain as assessment methods, 'Fatigue Impact Scale' for fatigue assessment, 'Hospital Anxiety-Depression Scale' for emotional state, 'EORTC QLQ-C30 Quality of Life Scale' for quality of life assessment, 'The FACT-Cog questionnaire' for cognitive state assessment, the' Pitsburg Sleep Quality Scale 'for the measurement of sleep quality, and the' Tampa Kinesophobia Scale 'for the assessment of kinesiophobia will be used.
Status | Completed |
Enrollment | 52 |
Est. completion date | December 1, 2022 |
Est. primary completion date | November 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Karnofsky performance scale =90, - Age between 18-70, - Taxan class chemotherapy program has been planned, - Not having regular exercise habits in the last 6 months, - Patients who gave consent to voluntarily participate in the study. Exclusion Criteria: - Having a communication problem - Standardized mini mental test score =23 - Previous chemotherapy treatments - Having a neurological, rheumatological or orthopedic problem that prevents working, - Presence of advanced lymphedema (Stage 3-4), - Recurrence during treatment, - Failing to use technology for tele-rehabilitation. |
Country | Name | City | State |
---|---|---|---|
Turkey | Florence Nightingale Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Brief Pain Inventory (BPI) | Assesses the severity of pain and its impact on functioning. Consisting of 17 questions, evaluating pain location, severity, and pain status, especially in the last 24 hours. Scores of 3-4 are defined as mild, 5-7 as moderate, 8-10 as severe pain in this scale. | 24 hours | |
Primary | 'Fatigue Impact Scale (FIS) | This scale, consisting of 40 items, evaluates the effects of fatigue on physical, cognitive, and psychosocial functions.Each item is rated on a five-step Likert scale, where 0 = no problems to 4 = extreme problems during the previous month. Ratings are summed to a total score, ranging from 0 to 160, and domain scores range from 0 to 40 for physical and cognitive functioning and 0-80 for the psychosocial functioning. Higher scores indicate greater limitations in functioning. | 1 week | |
Primary | Hospital Anxiety and Depression (HAD)" scale | It is a scale consisting of 14 questions and validity and reliability study has been done.[15] 7 of these questions evaluate anxiety, 7 evaluate depression in this Likert type measurement. The cut-off score for the anxiety subscale is 10/11 and for the depression subscale it is 7/8. Accordingly, those above these scores are considered at risk. | 1 week | |
Primary | European Organization for Research and Treatment of Cancer- Quality of life (EORTC QLQ-C30) questionnaire | It is used to measure the quality of life of individuals. The questionnaire has 3 subtitles and 30 questions: general health, functional score, and symptom score. The first 28 of the 30 items in the scale are a four-point Likert type scale and are scored as 1 (not at all) and 4 (very much) points. Questions 29 and 30 are the form of the domain of general well-being. Higher scores indicate better symptom severity for overall health and functional score, and worse for symptom score. | 1 week | |
Primary | Functional Assessment of Chronic Illness Therapy-Cognitive Function (FACT-Cog) | used to evaluate individuals' cognitive function. The questionnaire, consists of 37 items and 4 different subtitles, evaluates perceived cognitive skills, interpretations of other people, perceived cognitive disorders and quality of life. Individuals determine how valid a certain statement is for them in the last 7 days with a 5-point scale that includes scores between 0 (none) and 4 (very much). Higher scores indicate better cognitive functioning. | 1 week | |
Primary | Pittsburg Sleep Quality Index (PSQI) | consists of a total of 24 questions with 7 components.[18] These components; subjective sleep quality, time to fall asleep, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills and daytime dysfunction. If the total score obtained from these components is above 5, it indicates the "poor sleep" quality. For scores of 5 and below, sleep quality is considered 'good'. | 1 month | |
Primary | Tampa Kinesophobia Scale (TKS) | There are 17 questions in this scale, which was developed to measure the fear of motion / re-injury. 4-point Likert scoring (1 = Strongly disagree, 4 = Strongly agree) is used in the scale. The total score is between 17-68. The high score the person gets on the scale indicates that his kinesiophobia is also high. | 1 month |
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