Study Protocol: Stress Reduction in Breast Cancer Patients During Transition Into Survivorship Using Acupuncture - a Randomized Wait-list-controlled Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 112
- 试验地点
- 3
- 主要终点
- Distress at 8 weeks of intervention
研究概览
简要总结
This randomized controlled trial evaluates whether eight weeks of weekly acupuncture can reduce psychological distress in breast cancer patients who have recently completed primary therapy compared to standard-of-care wait-list control.
详细描述
Background Psychological distress is common in cancer patients-affecting roughly one-third with diagnosable mental health disorders and about half with significant psychosocial distress. This distress often spikes during diagnosis and treatment, decreases during therapy, but rises again after treatment ends. The transition from active treatment to aftercare is a particularly vulnerable phase, marked by loss of routine medical contact, fear of recurrence, ongoing side effects, and feelings of isolation. In breast cancer survivors, 20-40% experience clinically relevant distress, with many reporting unmet needs for psychological support. Chronic stress in cancer patients is linked to lower quality of life, worse treatment adherence, higher symptom burden, and poorer prognosis.
Acupuncture, a method from traditional Chinese medicine, has shown potential to reduce stress through modulation of the autonomic nervous system-reducing sympathetic overactivation and enhancing parasympathetic activity. It has been shown to improve symptoms such as pain, fatigue, and hot flushes in cancer patients, and to lower stress in other populations. However, there is almost no research on acupuncture's effect on post-treatment stress in breast cancer patients, especially in the critical early aftercare phase. Whether acupuncture can also improve resilience and treatment adherence in this context remains unknown.
Aim of the Study The study aims to investigate whether acupuncture reduces psychological distress in breast cancer patients who have recently completed primary therapy. Specifically, it tests whether the patients receiving acupuncture will have significantly lower perceived stress after eight weeks compared to a wait-list control group. Secondary objectives include exploring the effects of acupuncture on quality of life, fatigue, cognitive function, anxiety, depression, resilience, and therapy adherence, as well as documenting any adverse events.
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
- None
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
- •Patients with localized breast cancer having completed primary therapy (operation +/- chemotherapy +/- radiotherapy) in the last 6 months - Distress Thermometer ≥ 5 - Age ≥ 18 years - Signed informed consent for participation of the trial
- •Prior cancer is allowed
- •Prior treatment - including chemotherapy - for a prior malignant tumor (including breast cancer) is allowed
- •Concomitant participation in an experimental therapeutic drug trial is allowed
- •Ongoing or planned Anti-her2/neu, immune checkpoint inhibitor, antihormonal and CDK4/6 inhibitor therapy or other adjuvant treatment scheduled for > 3 months during study period is allowed
- •Use of other complementary methods (including mistletoe) is allowed.
排除标准
- •Patients with language or cognitive deficits (including impaired consciousness) that are incompatible with the participation in the study
- •Severe physical or psychiatric comorbidity that prevents a patient from participating in the study
- •Patients incapable of giving consent
- •Pregnancy
研究组 & 干预措施
Acupuncture:
8 sessions of acupuncture treatment, once a week
干预措施: Acupuncture (Procedure)
Wait-listed control group
Supportive care according to local standards will be given which may also include face-to-face psychosocial support or the participation of support groups. 8 weeks after the assessment T1 and upon completion of assessment T2, participants will receive access to 8 sessions of weekly acupuncture treatment.
干预措施: Standard supportive care (Other)
结局指标
主要结局
Distress at 8 weeks of intervention
时间窗: Post-intervention (after completion of the 8 week acupuncture therapy or SOC)
Distress is assessed after completion of 8 weeks of weekly acupuncture interventions or standard of care (SOC) by the Perceived Stress Scale (PSS-10). PSS-10 is a 10-item questionnaire widely used to assess stress levels in individuals. It measures the degree to which life has been perceived as unpredictable, uncontrollable und overloading over the last month. The responses are rated on a 5-point rating scale with a total score ranging from 0-40 while a higher total score indicating greater stress.
Distress at 8 weeks of intervention
时间窗: Post-intervention (after completion of the 8 week acupuncture therapy or SOC)
Distress is assessed after completion of 8 weeks of weekly acupuncture interventions or standard of care (SOC) by the Perceived Stress Scale (PSS-10). PSS-10 is a 10-item questionnaire widely used to assess stress levels in individuals. It measures the degree to which life has been perceived as unpredictable, uncontrollable und overloading over the last month. The responses are rated on a 5-point rating scale with a total score ranging from 0-40 while a higher total score indicating greater stress.
次要结局
- Quality of life assessment(Post-intervention (after completion of the 8 week acupuncture therapy or SOC))
- Distress over the course time(Before and after each acupuncture session during the the 8 week intervention period)
- Therapy Adherence(Post-intervention (after completion of the 8 week acupuncture therapy or SOC))
- Adverse Events:(After each acupuncture session during the the 8 week intervention period)
- Fatigue(Post-intervention (after completion of the 8 week acupuncture therapy or SOC))
- Self-reported cognitive impairment(Post-intervention (after completion of the 8 week acupuncture therapy or SOC))
- Anxiety(Post-intervention (after completion of the 8 week acupuncture therapy or SOC))
- Resilience(Post-intervention (after completion of the 8 week acupuncture therapy or SOC))
- Depression(Post-intervention (after completion of the 8 week acupuncture therapy or SOC))
研究者
Isabell Xiang Ge
Dr. med.
University Hospital, Basel, Switzerland