Effect of a Personalized Physical Exercise Program on Functional Capacity and Quality of Life in Older Colorectal Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Change in supplementary HRQOL scales for elderly cancer patients
研究概览
简要总结
The Exercise for COlorectal OLder patients (ECOOL program) is randomized controlled trial to assess the effects of an exercise program on physical function and health-related quality of life of patients 75 years and older with colorectal cancer undergoing surgery. ECOOL is a multicomponent home-based exercise intervention focused on the development of strength, balance, gait ability and inspiratory muscle function of older patients who receive weekly telephone follow-up from cancer diagnosis to 3 months after surgery. The investigators expect that ECOOL program will improve physical function and health-related quality of life of older patients 3 months after surgery and to maintain these benefits up to 6 months after surgery compared with the control group receiving usual care.
详细描述
Colorectal cancer (CRC) is the second most common cancer and the second cause of cancer-related death in Europe. Thirty-one percent of new cases are older than 74 years. The decrease in reserve capacity (i.e., frailty), comorbidity and the surgical treatment imply that the elderly patient is at greater risk of functional decline (reported between 15% and 18% three months after surgery).Up to 50% of those who have experienced functional decline do not recover previous levels of functional independence. The aim of this research is to investigate the effects of a multicomponent physical exercise program on physical function and health-related quality of life (HRQoL) of patients 75 years and older with CRC undergoing surgery. The exercise program focuses on the development of strength, balance, gait ability and inspiratory muscle function of older patients who receive weekly telephone follow-up from cancer diagnosis to 3 months after surgery. Weekly telephone follow-up is provided by an exercise specialist who monitors adherence to the exercise program and insists on its compliance, clarifies any doubt and prescribes exercise progression. Moreover, patients complete a supervised exercise session at baseline, during hospitalization and one month after surgery to ensure correct exercise execution and provide feedback. The investigators expect that ECOOL program will improve physical function and HRQoL of older patients 3 months after surgery and to maintain these benefits up to 6 months after surgery compared with the control group receiving usual care.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 75 years or older diagnosed with colorectal cancer.
- •Patients included in colorectal surgery waiting list of the Hospital General Universitario Gregorio Marañon (Madrid, Spain)
- •Patients able to communicate, understand and sign the informed consent.
排除标准
- •Patients finally excluded for colorectal surgery.
- •Patients with absolute contraindications to exercise
- •Walk disability (FAC <2)
- •Severe cognitive impairment (MMSE <18)
- •Terminal illness
结局指标
主要结局
Change in supplementary HRQOL scales for elderly cancer patients
时间窗: From baseline to 1 week, 3 months and 6 months after surgery
The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire for Elderly cancer patients (EORTC QLQ-ELD14) will be employed. The EORTC QLQ-ELD14 contains important age-specific issues for elderly cancer patients, which was developed to supplement the EORTC QLQ-C30. The QLQ-ELD14 comprises 14 items, made up of 5 scales (mobility, worries about others, future worries, maintaining purpose and burden of illness) and 2 single items (joint stiffness and family support). Scores in all areas range from 0 to 100, with higher scores indicating worse QoL in the case of mobility, joint stiffness, worries about others, future worries, and burden of illness, and better QoL in family support (feel able to talk to the family about the illness) and maintaining purpose.
Change in supplementary HRQoL scales for colorectal cancer patients
时间窗: From baseline to 1 week, 3 months and 6 months after surgery
The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire for Colorectal Cancer 29 (EORTC QLQ-CR29) will be employed. This questionnaire consists of 4 multi-item scales and 19 single-items assessing a range of symptoms and problems common among patients with colorectal cancer. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scale and functional single-items represents a high level of functioning, whereas a high score for the symptom scales and symptom single-items represents a high level of symptomatology or problems.
Change in functional capacity
时间窗: From baseline to 1 week, 3 months and 6 months after surgery
Change in functional status measured by Barthel Index. This index measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL). Including: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Scoring 0 points would be dependent in all assessed activities of daily living, whereas a score of 100 would reflect independence in these activities. Low scores on individual items highlight areas of need.
Change in Health-related Quality of Life (HRQoL) of cancer patients
时间窗: From baseline to 1 week, 3 months and 6 months after surgery
HRQOL measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). This questionnaire provides 0-100 scores in different single- or multi-item scales of three different domains of HRQoL: * Global health status (higher scores mean better health status) * Function (higher scores mean better function) * Symptomatology (higher scores mean worse symptomatology)
次要结局
- Change in physical function(From baseline to admission for surgery and at 1, 3 and 6 months after surgery)
- Change in frailty status(From baseline to admission for surgery and at 1, 3 and 6 months after surgery)
- Change in physical fitness(From baseline to admission for surgery and at 1, 3 and 6 months after surgery)
- Change in upper limb muscle size (thickness, mm)(From baseline to admission for surgery and at 1, 3 and 6 months after surgery)
- Change in lower limb muscle size (thickness, mm)(From baseline to admission for surgery and at 1, 3 and 6 months after surgery)
- Change in physical activity(From baseline to admission for surgery and at 1, 3 and 6 months after surgery)
- Length of stay in hospital after colorectal surgery (days)(From hospital admission for colorectal surgery up to discharge after surgery assessed up to 12 months.)
- Comprehensive Complication Index (CCI)(within a 90 days postoperative time period)
- Rate of mortality(From baseline to 6 month after surgery)
- Change in inspiratory muscle function(From baseline to admission for surgery and at 1, 3 and 6 months after surgery)
- Prevalence of Anxiety and Depression(At baseline and at 1, 3 and 6 months after surgery)
- Prevalence of cancer-cachexia(At baseline and at 1, 3 and 6 months after surgery)
- Number of hospital readmissions(From baseline to 3 and 6 months after surgery)
- Prevalence of sarcopenia(At baseline and at 1, 3 and 6 months after surgery)
研究者
Dr. Jose Antonio SERRA-REXACH
Head Of Geriatry Department
Hospital General Universitario Gregorio Marañon