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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a program to help people get ready for breast cancer treatment and surgery is practical to use. It is for adults getting cancer medicine before surgery and may include exercise, nutrition, medical care, and mental health support.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Patients must be age 18 or older and able to read and write in English.
  • Patients or their legal representative must give informed consent, meaning they agree after learning about the study.
  • Patients must have breast cancer and plan to get cancer medicine before surgery, with the goal of curing the cancer.
  • Patients must plan to start this treatment at City of Hope Orange County.
  • Patients must agree to see a rehabilitation doctor, start a training plan made for them, and complete follow-up checks.
  • Healthcare team members must be older than 18 and care for study patients as part of their usual work.
  • Healthcare team members must agree to complete a feedback survey.

Who can't join

  • Patients have cancer that has spread to distant parts of the body, another active cancer, or current or planned treatment for a cancer other than breast cancer.
  • Patients are pregnant or breastfeeding.
  • Patients have an uncontrolled illness that limits study activities, or a doctor finds their health too unstable for safe exercise.
  • Patients have met or exceeded exercise guidelines during the past month, based on their survey answers.
  • Patients started their second round of cancer medicine before seeing the rehabilitation doctor.
  • Patients cannot follow study instructions on their own because of mental, emotional, physical, or other problems.
  • Patients cannot answer surveys in English on their own or give informed consent.
  • Healthcare workers do not interact with study patients and cannot give relevant feedback.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (2)

CA