Effects of Progressive Relaxation Training on Artralgia, Quality of Life and Emotional Status in Breast Cancer Patients Receiving Aromatatase Inhibitor Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Brief pain inventory (BPI)
研究概览
简要总结
This study evaluates the effects of progressive relaxation exercises on artralgia, quality of life and anxiety-deppression in breast cancer patients receiving aromatase inhibitor. Half of the participants will receive supervised progressive relaxing exercises, while other half will not receive any exercise but only advice about relaxing.
Hypothesis: Progressive relaxation exercises improve the pain, quality of life and emotional status in breast cancer patients receiving aromatase inhibitor therapy.
详细描述
Aromatase inhibitors (AI) can cause musculoskeletal problems and increased risk of fracture as side effects in breast cancer (BC) survivors. In particular, arthralgia can be observed in almost 50% of patients receiving AI. Moreover; cognitive dysfunctions , decreases in quality of life , anxiety and depression , sleep problems and fatigue can be seen in some of patients receiving AI. According to these possible side effects, evaluation and treatment of such health profiles, pain and symptoms is important in terms of improving the quality of life of the patients.
Progressive muscle relaxation exercises (PRE) were first described by Jacobson in 1938. PRE are in use today with different arrangements and updates. It was well defined physiological, perceptual and behavioral positive findings of muscle relaxation.
PRE was thought to be effective on artralgia, quality of life and anxiety-depression in BC survivors receiving AI.
The patients have been searched from the medical records of brest health center in a local hospital. Necessary permissions to use this data was provided from medical coordinator of the hospital and from the coordinator of Breast Health Center.
The study was conducted as two armed, assessor blinded and randomised controlled trial. BC survivors who are receiving AI were randomised to study (performed PRE) or control (no intervention) group. Eligible patients were provided information about the the study and invited to participate in study via phone call. All assessments and exercise training was carried out in Physiotherapy Department of the same hospital. Outcomes were assessed baseline and at 6th-week intervention Primary endpoint was pain assessment assessed by Brief Pain inventory. Secondary endpoints were quality of life assessed by Functional Assessment of Chronic Illness Therapy and emotional status by Hospital Anxiety and Depression scales.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Using Aromatase Inhibitors for more than 6 months
- •Diagnosis of breast cancer stage 1-3
- •Postmenopausal woman aged under 70 years and with hormone-receptor positive
- •Approval of physician for participating in PRE program
排除标准
- •Participation on a regular physical training in the previous 6 months period
- •Communication problems
- •Neurological or ortopedical problems
- •Presence of lyphedema diagnosis
结局指标
主要结局
Brief pain inventory (BPI)
时间窗: 24 hours
Assesses the severity of pain and its impact on functioning. Consisting of 17 questions, evaluating pain location, severity, and pain status, especially in the last 24 hours. Scores of 3-4 are defined as mild, 5-7 as moderate, 8-10 as severe pain in this scale.
次要结局
- Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)(7 days)
- Hospital Anxiety and Depression scale (HAD)(7 days)
研究者
Umut Bahçacı
Principal investigator
Hacettepe University