NCT07317765进行中（未招募）不适用
Research on New Methods and New Models of Rehabilitation Intervention for Cancer Patients Based on Exercise and Psychological Intervention
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- SAS score
研究概览
简要总结
A Randomized Controlled Trial of Natural Psychotherapy for Intervening Negative Emotions in 100 Breast Cancer Patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with pathologically confirmed breast cancer, no distant metastasis, who have completed the perioperative period and not received subsequent treatment;
- •Aged 18-59 years with an expected survival period of ≥ 1 year;
- •Breast cancer patients with a self-reported depression score of ≥ 53 and/or anxiety score of ≥ 50 on self-rating scales (e.g., Self-Rating Depression Scale [SDS], Self-Rating Anxiety Scale [SAS]);
- •Voluntarily participating in the study after providing informed consent and signing the informed consent form.
排除标准
- •Patients with advanced breast cancer (stage IV with distant metastasis);
- •Patients receiving other psychological interventions besides this study (e.g., individual counseling, group therapy);
- •Patients with severe mental illness (e.g., schizophrenia), cognitive impairment (MMSE score < 24), heart disease, severe physical illness, other cancers, or complications;
- •Patients who are unable to cooperate with psychological interventions, questionnaires, or interviews; patients who request or voluntarily withdraw from this study.
结局指标
主要结局
SAS score
时间窗: 5 weeks
Self-Rating Anxiety Scale (SAS) Score range: The total score ranges from 20 to 80 after standard conversion. Interpretation of scores: Higher scores indicate more severe anxiety symptoms; conversely, lower scores reflect milder or no anxiety symptoms.
SDS score
时间窗: 5 weeks
Self-Rating Depression Scale (SDS) Score range: The total score ranges from 20 to 80 after standard conversion. Interpretation of scores: Higher scores represent more severe depressive symptoms; on the contrary, lower scores mean less severe or no depressive symptoms.
次要结局
- Ruminative Response Scale(5 weeks)
- Connor-Davidson Resilience Scale(5 weeks)
- ACC score(5 weeks)
- Functional Assessment of Cancer Therapy-Breast (FACT-B)(5 weeks)
研究者
Xiang Yang Zhang
Professor
Beijing HuiLongGuan Hospital
研究点 (1)
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