The Effect of a Multi-modal Program on Fear of Cancer Recurrence, Breast Cancer Symptoms and Social Support in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 主要终点
- Fear of Cancer Recurrence Inventory-Short Form
研究概览
简要总结
The goal of this clinical trial is to learn if MMP intervention can alleviate FCR , breast cancer symptoms and social support among breast cancer patients. he main questions it aims to answer are:
- Null Hypotheses (H0): There is no significant difference in FCR, breast cancer symptoms, and social support between the MMP intervention group and the control group.
- Alternative Hypotheses (H1): There are significant differences in FCR, breast cancer symptoms, and social support between the MMP intervention group and the control group
Researchers will compare MMP to a routine care to see if MMP works to alleviate FCR, breast cancer symptoms and social support.
Participants will:
- Receive interventions once per chemotherapy cycle for 8 weeks.
- The FCRI-SF, MSAS-SF-SC, and SSRS scales will be utilized to assess FCR levels, breast cancer symptoms and social support in both the experimental and control groups, with measurements conducted at baseline (T1), 8 weeks post-intervention (T2), and 12 weeks post-intervention (T3).
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis meets the criteria outlined in the Breast Cancer Diagnosis and Treatment Guidelines, with a pathological diagnosis of breast cancer and currently undergoing chemotherapy
- •Age ≥ 18 years
- •Clear consciousness and the ability to communicate independently
- •Aware of the diagnosis and has signed the informed consent form
排除标准
- •Presence of mental illness or cognitive impairment
- •Hearing or speech impairmen
- •Distant metastasis of cance
- •Severe physical illness or other malignant tumors requiring treatment
研究组 & 干预措施
Routine care
干预措施: Routine care (Other)
Multi-Modal Program (MMP)
MMP includes three modules: addressing psychological problems such as FCR; addressing problems related to breast cancer symptoms; and addressing tangible problems such as social support. Each module is divided into the chemotherapy period (hospitalization) and the chemotherapy interval (post-discharge). Each phase involves face-to-face, digital, and remote tools, with the intervention lasting 8 weeks. Each module has a different goal, and depending on the goal setting, the topic of the intervention is different. The goal of the information education stage is to improve patients' overall understanding of the disease and pay attention to the psychological problems of FCR. The goal of coping skills is that through the practice of coping skills, patients can learn to change thoughts, problem emotions, and behaviors. The objective of social support group interaction is to strengthen their social support networks.
干预措施: Multi-Modal Program (MMP) (Other)
结局指标
主要结局
Fear of Cancer Recurrence Inventory-Short Form
时间窗: baseline; 8 weeks post-intervention; 12 weeks post-intervention
It consists of nine items, each of which is assessed using a 5-point Likert scale ranging from 0 to 4. The total score ranges from 0-36, with elevated scores reflecting heightened FCR
The Social Support Rating Scale
时间窗: baseline; 8 weeks post-intervention; 12 weeks post-intervention
This instrument comprises 10 items categorized into three dimensions, yielding a total score between 0 and 66, where elevated scores denote greater social support.
The Chinese version of memorial symptom assessment scal
时间窗: baseline; 8 weeks post-intervention; 12 weeks post-intervention
The scoring range for physical symptoms is from 0-4, whereas other items are scored from 1-4. Higher scores indicate greater distress.
次要结局
未报告次要终点
研究者
LIU WEIMIN
Phd
Beijing Shijitan Hospital, Capital Medical University