Breast CancerPREHAB-BC65NCT07531836
Multicomponent Prehabilitation in Older Adults With Breast Cancer
A study testing Home-based Multicomponent Prehabilitation (Vivifrail), Supervised Multicomponent Prehabilitation and Comprehensive Geriatric Assessment and Optimization in people with Breast Cancer and Frailty, run by Fundacion Miguel Servet at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Breast Cancer, Frailty, Sarcopenia
- What is being tested?
- Home-based Multicomponent Prehabilitation (Vivifrail), Supervised Multicomponent Prehabilitation and Comprehensive Geriatric Assessment and Optimization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 4 Dec 2024to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥65 years
- Diagnosis of breast 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
Marta Lorente Escudero, MD, +34 648148503, marta.lorente.escudero@navarra.es
Nicolás Martínez Velilla, MD, PhD, +34 670900434, nicolas.martinez.velilla@navarra.es
About this study
Official title: Multidimensional Oncogeriatric Prehabilitation in Older Adults With Breast Cancer: A Randomized Controlled Trial Integrating Frailty and Biomarker Assessment
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.
Read more
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.
Read the 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 six weeks (including a 2-week preoperative phase and a 4-week postoperative phase), 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.
- Conditions
- Breast Cancer, Frailty, Sarcopenia, Aging, Functional Decline
- Being tested
- Home-based Multicomponent Prehabilitation (Vivifrail), Supervised Multicomponent Prehabilitation, Comprehensive Geriatric Assessment and Optimization
- Keywords
- Prehabilitation, Geriatric Oncology, Comprehensive Geriatric Assessment, Exercise Intervention, Vivifrail, Older Adults, Biomarkers, Functional Status, Quality of Life, Randomized Controlled Trial
- Medical subject headings
- Breast Neoplasms, Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based Multicomponent Prehabilitation (Vivifrail)Behavioural
Participants perform a structured home-based multicomponent exercise program based on the Vivifrail methodology, including strength, endurance, balance, and flexibility training over six weeks. The program is individualized according to baseline functional status.
Supervised Multicomponent PrehabilitationBehavioural
Participants receive a structured, supervised multicomponent exercise program delivered in a hospital setting, including aerobic, strength, balance, and flexibility training over six weeks.
Comprehensive Geriatric Assessment and OptimizationOther
Participants undergo comprehensive geriatric assessment with targeted interventions including nutritional optimization, medication review, and management of geriatric syndromes.
| Study group | Role | What they receive |
|---|---|---|
| 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 over six weeks, comprising a 2-week preoperative phase and a 4-week postoperative phase. The program is tailored according to baseline functional status and supported by caregiver supervision. Participants also receive comprehensive geriatric assessment and nutritional optimization. Receives: 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 six weeks, including a 2-week preoperative phase and a 4-week postoperative phase. The intervention is combined with comprehensive geriatric assessment, nutritional optimization, and individualized management of geriatric syndromes. Receives: Behavioral: Supervised Multicomponent Prehabilitation; Other: Comprehensive Geriatric Assessment and Optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 6-week intervention period.
Measured: Baseline to the end of the 6-week intervention period
Secondary outcomes (5)
Incidence of postoperative complications
Occurrence of postoperative complications within 30 days after surgery, classified according to the Clavien-Dindo classification.
Measured: Within 30 days after surgery
Length of hospital stay
Number of days from surgery to hospital discharge.
Measured: From date of surgery until hospital discharge, with a maximum follow-up of 30 days postoperatively
Functional decline 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.
Measured: Baseline to 30 days after surgery
Health-related quality of life
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).
Measured: Baseline to 30 days after surgery
Adherence to the intervention
Percentage of prescribed exercise sessions completed by participants.
Measured: During the 6-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start4 Dec 2024
- Primary completionMar 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolás Martínez Velilla, Fundacion Miguel Servet
- Investigators
- Marta Lorente Escudero, MD, Study director, Navarre Health Service (SNS-O), Navarre University Hospital (HUN), Pamplona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531836
- Sponsor's protocol ID
- HUN-PREHAB-BC-65
- Acronym
- PREHAB-BC65
- Status last verified
- Sep 2026
- First submitted
- 31 Mar 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to data protection regulations and institutional policies. De-identified data may be available from the corresponding author upon reasonable request, subject to ethical approval and data sharing agreements.
Publications
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.
PubMed 33191134
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Oncogeriatric Prehabilitation in Older Adults With Breast Cancer: A Randomized Controlled Trial Integrating Frailty and Biomarker Assessment
- ClinicalTrials.gov ID
- NCT07531836
- Acronym / sponsor ID
- PREHAB-BC65 / HUN-PREHAB-BC-65
- Conditions
- Breast Cancer, Frailty, Sarcopenia, Aging, Functional Decline
- Keywords
- Prehabilitation, Geriatric Oncology, Comprehensive Geriatric Assessment, Exercise Intervention, Vivifrail, Older Adults, Biomarkers, Functional Status
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 six weeks (including a 2-week preoperative phase and a 4-week postoperative phase), 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Home-based Multicomponent Prehabilitation (Vivifrail), Other: Comprehensive Geriatric Assessment and OptimizationParticipants perform a home-based multicomponent exercise program based on the Vivifrail methodology, including strength, endurance, balance, and flexibility training over six weeks, comprising a 2-week preoperative phase and a 4-week postoperative phase. The program is tailored according to baseline functional status and supported by caregiver supervision. Participants also receive comprehensive geriatric assessment and nutritional optimization. |
| Supervised Multicomponent Prehabilitation | Experimental | Behavioral: Supervised Multicomponent Prehabilitation, Other: Comprehensive Geriatric Assessment and OptimizationParticipants receive a supervised multicomponent exercise program delivered in the hospital setting, including aerobic, resistance, balance, and flexibility training over six weeks, including a 2-week preoperative phase and a 4-week postoperative phase. The intervention is combined with comprehensive geriatric assessment, nutritional optimization, and individualized management of geriatric syndromes. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥65 years
- Diagnosis of breast 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 over six weeks. The program is individualized according to baseline functional status. | Behavioural | Home-based Multicomponent Prehabilitation (Vivifrail) |
| Supervised Multicomponent PrehabilitationParticipants receive a structured, supervised multicomponent exercise program delivered in a hospital setting, including aerobic, strength, balance, and flexibility training over six weeks. | Behavioural | Supervised Multicomponent Prehabilitation |
| Comprehensive Geriatric Assessment and OptimizationParticipants undergo comprehensive geriatric assessment with targeted interventions including nutritional optimization, medication review, and management of geriatric syndromes. | Other | Home-based Multicomponent Prehabilitation (Vivifrail), Supervised Multicomponent Prehabilitation |
Primary outcome
Change in physical function assessed by Short Physical Performance Battery (SPPB)
Time frame: Baseline to the end of the 6-week intervention period
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 6-week intervention period.
5 secondary outcomes
Incidence of postoperative complications
Time frame: Within 30 days after surgery
Length of hospital stay
Time frame: From date of surgery until hospital discharge, with a maximum follow-up of 30 days postoperatively
Functional decline after surgery
Time frame: Baseline to 30 days after surgery
Health-related quality of life
Time frame: Baseline to 30 days after surgery
Adherence to the intervention
Time frame: During the 6-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Results publication: PubMed 33191134Welch 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to data protection regulations and institutional policies. De-identified data may be available from the corresponding author upon reasonable request, subject to ethical approval and data sharing agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marta Lorente Escudero, MD study director
Navarre Health Service (SNS-O), Navarre University Hospital (HUN), Pamplona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Multicomponent Prehabilitation (Vivifrail), Supervised Multicomponent Prehabilitation and Comprehensive Geriatric Assessment and Optimization in people with Breast Cancer and Frailty, run by Fundacion Miguel Servet at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Lorente Escudero, MD (+34 648148503, marta.lorente.escudero@navarra.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical function assessed by Short Physical Performance Battery (SPPB) (time frame: Baseline to the end of the 6-week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07531836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.