Using Acupuncture and Moxibustion to Promote Wellbeing and Improve Quality of Life for Patients With Upper Body Lymphoedema Secondary to Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP)
研究概览
简要总结
RATIONALE: Acupuncture and moxibustion may improve well-being and quality of life in patients with lymphedema caused by breast cancer or head, neck, and throat cancer.
PURPOSE: This clinical trial is studying how well acupuncture given together with moxibustion works in improving well-being and quality of life in patients with breast cancer or head, neck, and throat cancer who are undergoing standard treatment for lymphedema.
详细描述
OBJECTIVES:
- To test the acupuncture and moxibustion treatment strategies to obtain a first measure of response for the approach(es) used in patients with breast cancer or head, neck, and throat cancer undergoing standard treatment for secondary lymphedema.
- To assess whether this treatment is an acceptable intervention to cancer patients with secondary lymphedema and to their health care professionals.
- To disseminate the data to begin to build the evidence base for using this treatment in the management of lymphedema.
OUTLINE: Patients undergo acupuncture and moxibustion therapy once weekly for 7 treatment (Series 1). After completion of therapy, patients may choose to continue treatment for an additional 6 treatments (Series 2).
Patients complete a set of 4 questionnaires (i.e., sociodemographic, Short-Form-36, Positive and Negative Affect Scale (PANAS), and Measure Yourself Medical Outcome Profile (MYMOP)) at the first treatment and then periodically during study. Patients also complete a series of follow-up questionnaires designed to elicit feedback about their acupuncture experience.
After completion of study treatment, patients are followed at 1 and 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •male or female patients with either breast or head and neck cancer
- •diagnosis of mild to moderate uncomplicated lymphoedema
- •age 18 or over
- •under the care of the lymphoedema service for at leas:
- •two months (head and neck cancer patients)
- •three months (breast cancer patients)
- •no active cancer disease
- •at least 3 months since prior active cancer treatment (surgery, radiotherapy, chemotherapy, intravenous treatment)
- •more than 6 months since prior acupuncture treatment
- •concurrent adjuvant hormonal therapy allowed
- •concurrent anti-depressant medication allowed provided there has been no change in prescription or dosing within the past 3 months and patient intends to remain on the medication for the duration of study treatment and follow-up
- •Able to understand and communicate in English
- •Able to travel to the Lynda Jackson Macmillan Centre for treatment
- •Able to attend treatment once weekly for at least 7 consecutive weeks
- •Able to complete outcome measures
排除标准
- •bilateral breast cancer
- •advanced cancer disease
结局指标
主要结局
Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP)
时间窗: Before 7th acupuncture treatment
MYMOP is a questionnaire widely used for evaluating interventions based on holistic and participative principles. It enables respondants to specify and measure the treatment outcomes that are important to them.
Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile
时间窗: Before the 13th acupuncture treatment
MYMOP is a questionnaire widely used for evaluating interventions based on holistic and participative principles. It enables respondants to specify and measure the treatment outcomes that are important to them.
次要结局
未报告次要终点
研究者
Beverley de Valois PhD LicAc FBAcC
Research Acupuncturist
East and North Hertfordshire NHS Trust