Effectiveness of a Multicomponent Prehabilitation Program Combined With Biomarker Characterization in Older Adults With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in physical function assessed by Short Physical Performance Battery (SPPB)
研究概览
简要总结
Older adults with breast cancer frequently present with frailty, decreased functional reserve, and increased risk of postoperative complications. Prehabilitation programs have emerged as a promising strategy to improve physical function and clinical outcomes; however, evidence in geriatric oncology remains limited, particularly regarding the role of biological markers in predicting response to such interventions.
This study aims to evaluate the effectiveness of a multicomponent prehabilitation program in older adults with breast cancer, focusing on functional status, clinical outcomes, and quality of life. In addition, the study seeks to characterize biological markers associated with frailty and treatment response, with the goal of identifying potential predictors of benefit from prehabilitation.
Participants will undergo a structured prehabilitation intervention including physical exercise, nutritional optimization, and comprehensive geriatric assessment. Clinical, functional, and biomarker data will be collected longitudinally.
The results of this study may contribute to improving personalized care strategies in geriatric oncology and to identifying patients who are most likely to benefit from prehabilitation programs.
详细描述
This study is a prospective, randomized, controlled, single-blind clinical trial designed to evaluate the effectiveness of a multicomponent prehabilitation program in older adults with breast cancer, incorporating biological characterization to explore predictors of treatment response.
The trial will be conducted at the Navarre University Hospital (Pamplona, Spain). A total of 90 ambulatory patients aged 65 years or older with a confirmed diagnosis of breast cancer will be recruited and randomly assigned in a 1:1:1 ratio to usual care, a home-based multicomponent exercise program based on the Vivifrail methodology, or a supervised hospital-based intervention.
All participants will undergo baseline frailty screening followed by a comprehensive geriatric assessment to characterize functional, cognitive, nutritional, and clinical status. Assessments will be repeated at predefined time points throughout the perioperative period and during follow-up.
The intervention is structured into preoperative and postoperative phases and includes individualized multicomponent exercise, nutritional optimization, and targeted management of geriatric syndromes. The hospital-based intervention consists of supervised sessions over eight weeks, while the home-based intervention is adapted to baseline functional status.
Clinical, functional, and biological data will be collected longitudinally to evaluate the impact of the intervention and to identify predictors of clinical outcomes and treatment response.
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
Outcome assessors are blinded to group allocation. Due to the nature of the intervention, participants and care providers are not blinded.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥65 years
- •Diagnosis of cancer requiring elective surgery with curative intent
- •Candidate for prehabilitation program before surgery
- •Ability to walk (with or without assistive devices)
- •Ability to provide informed consent
排除标准
- •Urgent or emergency surgery
- •Severe cognitive impairment precluding participation in the intervention
- •Severe functional dependency (e.g., bedridden patients)
- •Medical contraindication to physical exercise
- •Life expectancy <3 months
研究组 & 干预措施
Usual Care
Participants receive standard clinical care according to routine practice, including management by oncology and surgical teams. Identified geriatric conditions are communicated to the treating physician for appropriate management.
Home-based Multicomponent Prehabilitation (Vivifrail)
Participants perform a home-based multicomponent exercise program based on the Vivifrail methodology, including strength, endurance, balance, and flexibility training. The program is tailored according to baseline functional status and supported by caregiver supervision. Participants also receive comprehensive geriatric assessment and nutritional optimization.
干预措施: Home-based Multicomponent Prehabilitation (Vivifrail) (Behavioral)
Home-based Multicomponent Prehabilitation (Vivifrail)
Participants perform a home-based multicomponent exercise program based on the Vivifrail methodology, including strength, endurance, balance, and flexibility training. The program is tailored according to baseline functional status and supported by caregiver supervision. Participants also receive comprehensive geriatric assessment and nutritional optimization.
干预措施: Comprehensive Geriatric Assessment and Optimization (Other)
Supervised Multicomponent Prehabilitation
Participants receive a supervised multicomponent exercise program delivered in the hospital setting, including aerobic, resistance, balance, and flexibility training over eight weeks. The intervention is combined with comprehensive geriatric assessment, nutritional optimization, and individualized management of geriatric syndromes.
干预措施: Supervised Multicomponent Prehabilitation (Behavioral)
Supervised Multicomponent Prehabilitation
Participants receive a supervised multicomponent exercise program delivered in the hospital setting, including aerobic, resistance, balance, and flexibility training over eight weeks. The intervention is combined with comprehensive geriatric assessment, nutritional optimization, and individualized management of geriatric syndromes.
干预措施: Comprehensive Geriatric Assessment and Optimization (Other)
结局指标
主要结局
Change in physical function assessed by Short Physical Performance Battery (SPPB)
时间窗: Baseline to 8 weeks (end of prehabilitation program)
Physical function will be assessed using the Short Physical Performance Battery (SPPB), a validated tool in older adults (score range 0-12, higher scores indicate better performance). The primary outcome will be the change in SPPB score from baseline to the end of the 8-week intervention.
次要结局
- Incidence of postoperative complications(Within 30 days after surgery)
- Length of hospital stay(From date of surgery until hospital discharge, with a maximum follow-up of 30 days postoperatively)
- Functional decline after surgery(Baseline to 30 days after surgery)
- Health-related quality of life(Baseline to 8 weeks and 30 days post-surgery)
- Adherence to the intervention(During the 8-week intervention period)
研究者
Nicolás Martínez Velilla
Principal Investigator, MD, PhD
Fundacion Miguel Servet