Aging, Breast Cancer, Frailty, Functional Decline, Sarcopenia
Conditions
Keywords
Prehabilitation, Geriatric Oncology, Comprehensive Geriatric Assessment, Exercise Intervention, Vivifrail, Older Adults, Biomarkers, Functional Status, Quality of Life, Randomized Controlled Trial
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALHome-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.
BEHAVIORALSupervised 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.
OTHERComprehensive Geriatric Assessment and Optimization
Participants undergo comprehensive geriatric assessment with targeted interventions including nutritional optimization, medication review, and management of geriatric syndromes.
Sponsors
Fundacion Miguel Servet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors are blinded to group allocation. Due to the nature of the intervention, participants and care providers are not blinded.
Intervention model description
Participants are randomly assigned in a 1:1:1 ratio to three parallel groups: usual care, a home-based multicomponent prehabilitation program, and a supervised hospital-based intervention.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical function assessed by Short Physical Performance Battery (SPPB) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative complications | Within 30 days after surgery | Occurrence of postoperative complications within 30 days after surgery, classified according to the Clavien-Dindo classification. |
| Length of hospital stay | From date of surgery until hospital discharge, with a maximum follow-up of 30 days postoperatively | Number of days from surgery to hospital discharge. |
| Functional decline after surgery | Baseline to 30 days after surgery | Functional decline defined as a decrease in the Short Physical Performance Battery (SPPB) score (range 0 to 12, with higher scores indicating better physical performance) or loss of independence in activities of daily living compared to baseline. |
| Health-related quality of life | Baseline to 8 weeks and 30 days post-surgery | Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30; scores transformed to a 0-100 scale, where higher scores indicate better functioning or worse symptoms depending on the domain). |
| Adherence to the intervention | During the 8-week intervention period | Percentage of prescribed exercise sessions completed by participants. |
Countries
Spain
Contacts
CONTACTMarta Lorente Escudero, MD
CONTACTNicolás Martínez Velilla, PhD
STUDY_DIRECTORMarta Lorente Escudero, MD
Navarre Health Service (SNS-O), Navarre University Hospital (HUN), Pamplona, Spain
Outcome results
None listed