Design and Evaluation of the Effects of a Physical Therapy Program With Digital Support in Patients With Breast Cancer Surgery. A Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Disabilities of the Arm, Shoulder and Hand Score (DASH)
研究概览
简要总结
Breast cancer surgery usually results in reduced range of motion of the shoulder joint, weakness of the musculature and altered scapular kinematics during movement. These factors limit activities of daily living, so rehabilitation exercises help to restore function after shoulder surgery.
Women with breast cancer often have a life conditioned by the sequelae or morbidity secondary to the treatment of the disease and, despite the high cure rate, many patients are unable to regain their initial quality of life. Cancer therapies can leave physical, psychological and psychosocial sequelae, which may manifest themselves or persist even years after the end of treatment.
For all these reasons, patients who have undergone cancer treatment need physical rehabilitation as well as psychological and social care to support them in their new stage of life, and to optimise the rehabilitation programme, it is necessary to identify each patient's individual needs,
The digital support proposed in this study enables the development of a physiotherapy programme for patients with breast cancer in a situation of health crisis, which includes providing assistance, information, accompaniment, help and treatment to these patients in a comprehensive way, based on the biopsychosocial model.
详细描述
DESIGN: Single-centre, assessor-blinded, parallel-group, randomised controlled clinical trial.
METHODS: The study will be carried out at the Ramon y Cajal hospital with 92 patients diagnosed and operated on for breast cancer.
Patients who come to the consultation of the rehabilitation doctors will be assessed, considering the inclusion and exclusion criteria. Those who may be candidates will be informed about the study and referred to the physiotherapy department where the treatment orders for these patients will be received and an appointment will be made. This is the start of the recruitment phase.
Those who meet the criteria and agree to participate in the study will be assigned an identification code and will be randomised into the two groups, the intervention group and the conventional treatment group.
Patients who do not meet the inclusion criteria or refuse to participate in the study will receive conventional treatment.
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 (Outcomes Assessor)
盲法说明
The assessor will assess patients at baseline, 6 weeks, 12 weeks, and 6 months and will not know which arm of the study each patient belongs to.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stage I, II or III of Breast cancer treated by surgery.
- •Medical authorisation for participation.
- •Internet access.
- •Basic computer skills.
- •Signed informed consent.
- •No bilateral mastectomy.
- •No metastases.
- •Post-intervention period of 10 days to 3 months.
- •Age 18-85 years.
- •No previous shoulder pathologies.
- •No pathology that prevents exercise.
- •Understanding of the Spanish language.
排除标准
- •Breast cancer treated without surgery.
- •Patient in severe psychiatric treatment who may present difficulties for participation in the study.
- •Stage IV cancer.
- •Any other clinical condition or previous therapy that contraindicates one or more of the techniques included in the programme, as the intervention may not be safe for the patient and therefore the person would not be eligible to participate in the study.
结局指标
主要结局
Disabilities of the Arm, Shoulder and Hand Score (DASH)
时间窗: 3 months
Global assessment of the functionality of the upper limb,
次要结局
- Tampa Scale for Kinesiophobia (TSK-11SV)(12 weeks)
- European organization for research and treatment of cancer quality life questionnaire core 30. (QLQ-C30-B23)(12 weeks)
- Hospital Anxiety and Depression Scale (HADS)(12 weeks)
- Range Of Motion (ROM)(12 weeks)
- Brief Pain Inventory (BPI)(12 weeks)
研究者
Ana Belén Romojaro Rodríguez
Physiotherapist
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal