Breast Cancer Clinical Trial
Official title:
The Effect of Aerobic Exercise Based Telerehabilitation Program on Upper Extremity Functıonality, Cognitive Status and Quality of Life in Patients With Survival Breast Cancer
The aim of this study is to determine the effect of telerehabilitation-based aerobic exercises on upper extremity functionality, cognitive status and quality of life in patients with survival breast cancer.
Status | Recruiting |
Enrollment | 69 |
Est. completion date | December 30, 2023 |
Est. primary completion date | May 30, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Between the ages of 18 and 65 - Literate - Having a diagnosis of breast cancer stage 1-2 - Complete breast cancer primary treatment at least 6 months before (excluding hormone therapy/aromatase inhibitors) - Providing the cooperation - Be woman - Physically inactive (60 minutes of structured exercise per week <) - Patients willing and voluntarily to participate in the study Exclusion Criteria: - Who are using one of the psychotic, anxiolytic, antidepressant, analgesic and sleeping pills - With metastases - Those with a history of lymphedema - With neurological disease - Those who are pregnant or breastfeeding - Uncontrolled hypertensive patients - Those incapable of verbal communication or physical movement - Patients who did not agree to participate in the study |
Country | Name | City | State |
---|---|---|---|
Turkey | Ramazan Cihad Yilmaz | Gaziantep |
Lead Sponsor | Collaborator |
---|---|
Hasan Kalyoncu University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) | The EORTC-QLQ-C30 Quality of Life Scale includes 30 questions and three subheadings: general well-being, functional difficulties, and symptom control. The first 28 of the 30 items in the scale are a four-point Likert-type scale and the items are evaluated as Never: 1, A little: 2, Quite: 3 or A lot: 4 points. In the 29th question of the scale, the patient is asked to evaluate his health on a scale from 1 to 7 (1: Very poor and 7: Excellent), and in the 30th question, the general quality of life. The 29th and 30th questions constitute the general well-being area. High scores in this section indicate a high quality of life, and low scores indicate a decrease in quality of life. (Hospital group, telerehabilitation group and control group will be evaluated) | A day before the treatment | |
Primary | Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) | This form evaluates the parameters of cognitive sensitivity (sharpness), attention and coordination, memory, verbal fluency, functional confusion, observations of others about the individual, change in functionality compared to before, and quality of life. It consists of 4 subtitles and 37 questions in total. Questions in the sections of perceived cognitive impairment, comments from other people, perceived cognitive skills, and impact on quality of life are scored between 0 and 4 (0-several times per day times, 4-never). In 9 questions in the field of perceived cognitive skills, the score calculation is evaluated as 0-none, 4-too much. Perceived cognitive disorders and perceived cognitive skills subsections contain opposite questions and the last 2 questions are not included in the scoring. The increase in the total score indicates the goodness of the situation in terms of cognitive functions.(Hospital group, telerehabilitation group and control group will be evaluated) | A day before the treatment | |
Primary | Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire | The Arm, Shoulder and Hand Injuries Questionnaire (DASH) will be used to evaluate the functions of the upper extremities.This questionnaire assesses disability, activity limitations, restriction on leisure activities and participation in work. The DASH questionnaire consists of three parts. The first part consists of 30 questions. 21 questions determine the patient's difficulty during activities of daily living, five questions determine the symptoms (pain, activity-related pain, tingling, stiffness, weakness), each of the remaining four questions determine the social function, work, sleep and the patient's function /symptom score.(Hospital group, telerehabilitation group and control group will be evaluated) | A day before the treatment | |
Secondary | Chronic Disease Treatment Functional Assessment Fatigue (FACIT Fatigue) Scale | It is a measurement tool that subjectively evaluates the fatigue in the last week and consists of 13 expressions. The scale has a five-point Likert scale of 0 = not at all, 1 = very little, 2 = a little, 3 = a lot, and 4 = a lot. 11 items (1-6, 9-13) of the scale contain reverse expressions. The 7th and 8th items of the scale are calculated flat. The scores that can be obtained from the scale range from 0 to 52. A high total score on the scale indicates that the severity of fatigue is low. It is reported that the perception fatigue is clinically severe if the score from the scale is 30 or less. (Hospital group, telerehabilitation group and control group will be evaluated) | Baseline, 6 weeks, 12 weeks, and 6 months | |
Secondary | EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) | The EORTC-QLQ-C30 Quality of Life Scale includes 30 questions and three subheadings: general well-being, functional difficulties, and symptom control. The first 28 of the 30 items in the scale are a four-point Likert-type scale and the items are evaluated as Never: 1, A little: 2, Quite: 3 or A lot: 4 points. In the 29th question of the scale, the patient is asked to evaluate his health on a scale from 1 to 7 (1: Very poor and 7: Excellent), and in the 30th question, the general quality of life. The 29th and 30th questions constitute the general well-being area. High scores in this section indicate a high quality of life, and low scores indicate a decrease in quality of life. (Hospital group, telerehabilitation group and control group will be evaluated) | 6 weeks, 12 weeks, and 6 months | |
Secondary | Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) | This form evaluates the parameters of cognitive sensitivity (sharpness), attention and coordination, memory, verbal fluency, functional confusion, observations of others about the individual, change in functionality compared to before, and quality of life. It consists of 4 subtitles and 37 questions in total. Questions in the sections of perceived cognitive impairment, comments from other people, perceived cognitive skills, and impact on quality of life are scored between 0 and 4 (0-several times per day times, 4-never). In 9 questions in the field of perceived cognitive skills, the score calculation is evaluated as 0-none, 4-too much. Perceived cognitive disorders and perceived cognitive skills subsections contain opposite questions and the last 2 questions are not included in the scoring. The increase in the total score indicates the goodness of the situation in terms of cognitive functions.(Hospital group, telerehabilitation group and control group will be evaluated) | 6 weeks, 12 weeks, and 6 months | |
Secondary | Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire | The Arm, Shoulder and Hand Injuries Questionnaire (DASH) will be used to evaluate the functions of the upper extremities.This questionnaire assesses disability, activity limitations, restriction on leisure activities and participation in work. The DASH questionnaire consists of three parts. The first part consists of 30 questions. 21 questions determine the patient's difficulty during activities of daily living, five questions determine the symptoms (pain, activity-related pain, tingling, stiffness, weakness), each of the remaining four questions determine the social function, work, sleep and the patient's function /symptom score.(Hospital group, telerehabilitation group and control group will be evaluated) | 6 weeks, 12 weeks, and 6 months |
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