E-Cuidate: Effectiveness of a Telerehabilitation System in Women Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Quality of life
研究概览
简要总结
Background: Cancer is increasingly viewed as a chronic disease and therefore there is a growing need for long-term treatments. Breast cancer survivors suffer physical impairment after oncology treatment. This impairment reduces quality of life (QoL) and increases the prevalence of conditions associated to unhealthy life-style.
Objective: The overall objective of e-Cuidate telerehabilitation will be to evaluate short and long-term effects telehealth program.
Methods: Seventy-two breast cancer survivors (age range: 18-65 years) will be recruited through oncology and breast units at the Virgen de las Nieves Hospital and San Cecilio Hospital and associations of breast cancer patients in Granada. Patients will be randomized to receive the online rehabilitation group (n=36) or usual care (control) group (n=36). Telerehabilitation group will receive an eight-week online intervention and control group receive recommendations about usual care.
Discussion: The investigators study attempts to increase the level of fitness and reduce musculoskeletal disorders in breast cancer patients through a strategy for care based on telerehabilitation to promote therapeutic exercise.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stage I, II, or IIIA breast cancer
- •Medical clearance of participation
- •Without chronic disease or orthopaedic that would interfere with ability to participate in a physical activity program
- •Access to Internet
- •Basic ability to use the computer or living with a relative who has this ability
- •Completion of adjuvant therapy except for hormone therapy
- •No history of cancer recurrence
- •Have interest in improving lifestyle: fitness/stress level
- •Have signed informed consent
排除标准
- 未提供
研究组 & 干预措施
Telerehabilitation group
干预措施: Telerehabilitation group (Behavioral)
Control group
Information about usual care
结局指标
主要结局
Quality of life
时间窗: Participants will be followed over 8 weeks
The primary outcome will be assessed with The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0. This questionnaire includes both multi-item scales and single-item measures. These are composed by five functional scales, three symptom scales, a global health status/QoL scale, and six single items. The scores have to be averaged and transformed linearly to obtain a range of score from 0 to 100 where high score meaning a great response level. The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23) which is a breast cancer module of EORTC QLQ-C30 will also be assessed
次要结局
- Algometry(Participants will be followed over 8 weeks)
- The Visual Analogue Scale (VAS) for pain(Participants will be followed over 8 weeks)
- Pain(Participants will be followed over 8 weeks)
- Body composition(Participants will be followed over 8 weeks)
- Physical measurement(Participants will be followed over 8 weeks)
- Cardiorespiratory fitness(Participants will be followed over 8 weeks)
- Fatigue(Participants will be followed over 8 weeks)
- Anxiety and depression(Participants will be followed over 8 weeks)
- Cognitive function(Participants will be followed over 8 weeks)
- Accelerometry(Participants will be followed over 8 weeks)
研究者
Manuel Arroyo Morales
PhD
Universidad de Granada