Relaxation Training By Tele-Rehabilitation Program In Patients With Breast Cancer Receiving Chemotherapy During COVID-19.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Brief Pain Inventory (BPI)
研究概览
简要总结
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.
详细描述
The study is planned as a single center, single-blind (assessment), randomized and home-based tele-rehabilitation intervention. The study will be conducted at Gayrettepe Florence Nightingale Hospital between January 2021 and November 2022. Participants will consist of individuals with breast cancer undergoing a routine taxane chemotherapy program. The participants will randomly be assigned to study (telerehabilitation-based relaxation exercises) and control groups.
Participants who will meet criteria's will be informed by the medical oncologist involved in the study in the medical oncology clinic in hospital and an informed consent form will be provided to the volunteers who want to participate in the study. After approval of the consent form, participants will be randomly divided into two groups. To provide randomization at a 1:1 sharing ratio, 2 blocks will be created with the "block randomization" method, computer-generated numbers will be put in sealed envelopes. The number from the envelope selected by the patients will indicate which block will be. Randomizations will be made by a non-study researcher. The assessor will also be blind to allocations of the groups. Demographic information of the participants will be recorded and pain, fatigue, emotional state, quality of life, cognitive status, sleep quality and kinesiophobia will be evaluated.
In order to calculate the sample size, power analysis (80% power and 5% type 1 error) was performed with the standard deviation and confidence interval data of the "pain" parameter provided from a reference article[9] similar to this study, The target sample size was determined with the aim of recruiting at least 20 participants per group, based on a power of 80% and a confidence interval of 95%, with an effect size of 0,91. With a possible 30% loss of patient to follow-up was added and totally, it was aimed to include 26 patients in each group.
Assessments will be made at baseline and after 6 weeks of intervention. In case of significant results, exercise programs will be provided to the participants who cannot take the relevant exercises in the control group.
Interventions Telerehabilitation-based relaxation exercise group (EG)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Karnofsky performance scale ≥90,
- •Age between 18-65,
- •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.
排除标准
- •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.
结局指标
主要结局
Brief Pain Inventory (BPI)
时间窗: 24 hours
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.
Functional Assessment of Chronic Illness Therapy-Cognitive Function (FACT-Cog)
时间窗: 1 week
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.
Pittsburg Sleep Quality Index (PSQI)
时间窗: 1 month
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'.
'Fatigue Impact Scale (FIS)
时间窗: 1 week
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.
European Organization for Research and Treatment of Cancer- Quality of life (EORTC QLQ-C30) questionnaire
时间窗: 1 week
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.
Hospital Anxiety and Depression (HAD)" scale
时间窗: 1 week
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.
Tampa Kinesophobia Scale (TKS)
时间窗: 1 month
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.
次要结局
未报告次要终点
研究者
Umut Bahçacı
Principal investigator
Hacettepe University