Clinical trial · Interventional
Prehabilitation for Improving Outcomes in Breast Cancer Patients Undergoing Neoadjuvant Systemic Treatment and Surgery
Physiatry-Led Prehabilitation During Neoadjuvant Systemic Treatment Before Breast Cancer Surgery: A Pilot Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
This clinical trial evaluates whether a prehabilitation program is feasible for breast cancer patients receiving neoadjuvant systemic treatment before surgery. Many people with breast cancer have problems during and after treatment. These issues can make daily activities harder and make it harder for a person to enjoy daily life. Some people with breast cancer already have other health problems, like joint pain or nerve problems, which can make these symptoms worse. Research shows that being stronger and more active before and during treatment may help people do better during cancer care and recover more easily. However, many patients do not get this type of support early enough. Prehabilitation is a program that helps patients get ready for cancer treatment and surgery. It may include help with medical care, exercise, food and nutrition, and mental health. The goal is to help patients stay as strong and healthy as possible before surgery. Starting prehabilitation during neoadjuvant systemic treatment before surgery may help breast cancer patients feel better, stay stronger and recover more easily during treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (13)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aerobic Exercise | Other | — | UNRESOLVED |
| Bioelectric Impedance Analysis | Procedure | — | UNRESOLVED |
| Consultation | Other | — | UNRESOLVED |
| Educational Intervention | Other | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Nutritional Intervention | Other | — | UNRESOLVED |
| Physical Performance Testing | Other | — | UNRESOLVED |
| Psychosocial Care | Behavioral | — | UNRESOLVED |
| Questionnaire Administration |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (prehabilitation)
- description
- See Detailed Description.
- interventionNames
- Other: Aerobic Exercise
- Procedure: Bioelectric Impedance Analysis
- Other: Consultation
- Other: Educational Intervention
- Other: Electronic Health Record Review
- Other: Nutritional Intervention
- Other: Physical Performance Testing
- Behavioral: Psychosocial Care
- Other: Questionnaire Administration
- Other: Referral
- Other: Resistance Training
- Procedure: Spiritual Therapy
- Procedure: Tailored Intervention
Primary outcomes (1)
- measure
- Adherence (feasibility)
- timeFrame
- Up to day 168
- description
- Feasibility of exercise will be determined by participant adherence to the prescribed exercise for the evaluable preoperative study period with goal of adherence of \> 70% for \> 70% of the preoperative time period. Adherence is defined as a ratio of completed versus planned exercise amount (90 minutes per week of moderate intensity aerobic exercise when on neoadjuvant systemic treatment (NST), 150 minutes per week when off NST, and 2 times per week resistance exercise), averaged between the types of exercise. Feasibility of nutrition and mind/spirit practice will also be determined based on participant adherence (\> 70% of enrolled patients during the preoperative time period).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * PATIENT INCLUSION: * Documented informed consent of the participant and/or legally authorized representative * Willingness to comply with a physiatry consultation, start a tailored training program, and follow-up assessments * Age: \>= 18 years * Able to read and write in English * A diagnosis of breast cancer planned for curative intent neoadjuvant systemic treatment (NST) with a goal of breast cancer surgery * Plan to start NST at City of Hope Orange County * HEALTHCARE TEAM INCLUSION: * Willingness to complete the Healthcare Team Feedback Survey * \> 18 years old * Physicians, advanced practice providers, nurses, medical assistants, rehabilitation therapists, social workers, dietitians, mental health professionals, and other clinical staff who interact with study participants in the course of routine care Exclusion Criteria: * PATIENT EXCLUSION: * Current or planned cancer treatment for a second cancer not of breast origin * Clinically significant uncontrolled illness limiting participation with the research intervention and assessments * Cancer with distant metastases * Other active malignancy * Pregnant or breastfeeding * Physician judgment (based on information gathered during consult visit) of medical instability including conditions such as unstable cardiopulmonary status, recent embolism (\< 4 weeks), suspected or known dissecting aneurysm, severe hypertension (resting blood pressure \> 180/110), chronic infectious disease, uncontrolled metabolic disease (e.g. diabetes with ketosis), active seizure, mental/physical impairments limiting safe exercise, or sepsis * Meeting or exceeding exercise guidelines over the last one month, based on the responses from the Godin Leisure-Time Physical Activity and Exercise Intent Questionnaire * Started second cycle before the physiatry consult * Inability to independently follow instructions for study assessments for any reason such as mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry. (These patients may not be able to cooperate with the prehabilitation interventions or with the data collection process.) * Unable to independently answer questionnaires in English or provide informed consent for any reason * HEALTHCARE TEAM EXCLUSION: * Healthcare workers who do not interact with study participants and therefore cannot provide relevant feedback
References
Publications (0)
Data not yet available