Reborn Lifestyle Adjustment Program for Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Breast Cancer Specific Quality of Life Scale
研究概览
简要总结
The aim of this study is to investigate the effects of the reborn lifestyle regulation program on physical activity, fatigue level, pain, mental health burden and quality of life in breast cancer patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being a female individual aged 18 or older
- •Have been diagnosed with Stage I, II, or III breast cancer
- •At least 6 months have passed since the completion of chemotherapy
- •Approval by an oncologist to participate in the study
- •Having internet access and the ability to connect online
- •Scoring above 23 on a standardized Mini Mental Status Examination Test
- •Being in the contemplation stage according to the Transtheoretical Model
排除标准
- •Having a neurological or systemic disease that could significantly affect the course of the intervention
- •Having metastasis that could impact the sustainability of the study
- •Suffering from neuropathic pain
- •Having participated in a healthy lifestyle program within the last 3 months
结局指标
主要结局
Breast Cancer Specific Quality of Life Scale
时间窗: 12 weeks
An adjunct to the EORTC QLQ-C30, this scale assesses breast cancer-specific symptoms and treatment-related side effects. It includes subscales for body image, sexual function, and treatment side effects, rated on a 4-point Likert scale. The Turkish version was adapted by Demirci et al. in 2011.
Modified Borg Scale
时间窗: 12 weeks
Developed by Borg in 1970, this unidirectional scale (0-10) measures the effort exerted during physical exercise, particularly in assessing dyspnea severity. Participants rate their dyspnea over the past week, with "0" indicating no shortness of breath and "10" indicating severe shortness of breath.
Sit up Test
时间窗: 12 weeks
This test measures leg strength and endurance by counting how many times a participant can sit and stand from a chair within 30 seconds. A score of fewer than 10 sit-ups indicates lower extremity weakness. The Turkish validity and reliability were established by Demir and Öztürk in 2020.
Cancer Fatigue Scale
时间窗: 12 weeks
The CFS, developed by Okuyama et al. (2000) and validated in Turkish by Şahin et al. (2018), evaluates fatigue in individuals with cancer across three domains: physical, emotional, and cognitive. The scale consists of 15 items, rated on a Likert scale from 1 (not at all) to 5 (very much).
McGill-Melzack Pain Questionnaire
时间窗: 12 weeks
Developed by Melzack in the 1970s and validated in Turkish by Kuguoglu et al. (2003), the MPQ assesses the quality and intensity of pain through four sections, including sensory and perceptual dimensions. Scores range from 0 to 112, with higher scores indicating more severe pain.
Depression Anxiety Stress Scale (DASS-21)
时间窗: 12 weeks
The DASS-21, developed by Lovibond \& Lovibond (1995) and validated in Turkish by Sarıçam (2018), assesses mental health across three dimensions: depression, anxiety, and stress. Each dimension consists of 7 items rated on a 4-point Likert scale. Higher scores indicate more severe symptoms.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: 12 weeks
Developed by Buyyse et al. (1989) and validated in Turkish by Agargun et al., the PSQI assesses sleep quality over the past month across seven components. Scores range from 0 to 21, with higher scores indicating poorer sleep quality.
次要结局
- European Organization for Research and Treatment of Cancer Quality of Life Scale(12 weeks)
- University of Rhode Island Scale for Assessing Change(Baseline)
- Mini Mental Status Examination Test(Baseline)
- Visual Analog Scale(12 weeks)