Multicomponent Prehabilitation in Older Adults With Breast Cancer

Официальное название

Effectiveness of a Multicomponent Prehabilitation Program Combined With Biomarker Characterization in Older Adults With Breast Cancer

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Home-based Multicomponent Prehabilitation (Vivifrail)
  Participants perform a structured home-based multicomponent exercise program based on the Vivifrail methodology, including strength, endurance, balance, and flexibility training. The program is individualized according to baseline functional status.
• Поведенческое Supervised Multicomponent Prehabilitation
  Participants receive a structured, supervised multicomponent exercise program delivered in a hospital setting, including aerobic, strength, balance, and flexibility training over eight weeks.
• Другое Comprehensive Geriatric Assessment and Optimization
  Participants undergo comprehensive geriatric assessment with targeted interventions including nutritional optimization, medication review, and management of geriatric syndromes.

Первичные конечные точки

• Change in physical function assessed by Short Physical Performance Battery (SPPB) [Срок оценки: Baseline to 8 weeks (end of prehabilitation program)]

Вторичные конечные точки (5)

• Incidence of postoperative complications [Срок оценки: Within 30 days after surgery]
• Length of hospital stay [Срок оценки: From date of surgery until hospital discharge, with a maximum follow-up of 30 days postoperatively]
• Functional decline after surgery [Срок оценки: Baseline to 30 days after surgery]
• Health-related quality of life [Срок оценки: Baseline to 8 weeks and 30 days post-surgery]
• Adherence to the intervention [Срок оценки: During the 8-week intervention period]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Universitario de Navarra — Pamplona

Публикации

• Welch SA, Ward RE, Beauchamp MK, Leveille SG, Travison T, Bean JF. The Short Physical Performance Battery (SPPB): A Quick and Useful Tool for Fall Risk Stratification Among Older Primary Care Patients. J Am Med Dir Assoc. 2021 Aug;22(8):1646-1651. doi: 10.1016/j.jamda.2020.09.038. Epub 2020 Nov 13. PMID 33191134

Идентификаторы

NCT: NCT07531836 · HUN-PREHAB-BC-65

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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