Multicomponent Prehabilitation in Older Adults With Breast Cancer

NCT07531836 | Recruiting

• 1 other identifier: HUN-PREHAB-BC-65
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Frailty; Sarcopenia; Aging; Functional Decline

Keywords

Prehabilitation; Geriatric Oncology; Comprehensive Geriatric Assessment; Exercise Intervention; Vivifrail; Older Adults; Biomarkers; Functional Status; Quality of Life; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change in physical function assessed by Short Physical Performance Battery (SPPB)

  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.

  Baseline to 8 weeks (end of prehabilitation program)

Secondary Outcomes (5)

• 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

Study Arms (3)

Usual Care

NO INTERVENTION

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)

EXPERIMENTAL

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.

Behavioral: Home-based Multicomponent Prehabilitation (Vivifrail); Other: Comprehensive Geriatric Assessment and Optimization

Supervised Multicomponent Prehabilitation

EXPERIMENTAL

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.

Behavioral: Supervised Multicomponent Prehabilitation; Other: Comprehensive Geriatric Assessment and Optimization

Interventions

Home-based Multicomponent Prehabilitation (Vivifrail) BEHAVIORAL

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.

Home-based Multicomponent Prehabilitation (Vivifrail)

Supervised Multicomponent Prehabilitation BEHAVIORAL

Participants receive a structured, supervised multicomponent exercise program delivered in a hospital setting, including aerobic, strength, balance, and flexibility training over eight weeks.

Supervised Multicomponent Prehabilitation

Comprehensive Geriatric Assessment and Optimization OTHER

Participants undergo comprehensive geriatric assessment with targeted interventions including nutritional optimization, medication review, and management of geriatric syndromes.

Home-based Multicomponent Prehabilitation (Vivifrail); Supervised Multicomponent Prehabilitation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion Miguel Servet: lead

Study Sites (1)

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Related Publications (1)

• Welch SA,Ward RE,Beauchamp MK,Leveille SG,Travison T,Bean JF

  RESULT

MeSH Terms

Conditions

Breast Neoplasms; Frailty; Sarcopenia

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Marta Lorente Escudero, MD

  Navarre Health Service (SNS-O), Navarre University Hospital (HUN), Pamplona, Spain

  STUDY DIRECTOR

Central Study Contacts

Marta Lorente Escudero, MD

CONTACT

+34 648148503; marta.lorente.escudero@navarra.es

Nicolás Martínez Velilla, PhD

CONTACT

+34 670900434; nicolas.martinez.velilla@navarra.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to group allocation. Due to the nature of the intervention, participants and care providers are not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Model Details: 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.

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 15, 2026
• Study Start: December 4, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)