About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Aerobic Exercise
Other interventionParticipate in aerobic exercise
Bioelectric Impedance Analysis
Procedure/SurgeryAncillary studies
Consultation
Other interventionAttend physiatry consultation
Educational Intervention
Other interventionReceive prehabilitation education
Electronic Health Record Review
Other interventionAncillary studies
Nutritional Intervention
Other interventionReceive nutritional guidance
Physical Performance Testing
Other interventionAncillary studies
Psychosocial Care
BehavioralReceive psychospiritual care
Questionnaire Administration
Other interventionAncillary studies
Referral
Other interventionReceive referral(s)
Resistance Training
Other interventionParticipate in resistance exercise
Spiritual Therapy
Procedure/SurgeryReceive psychospiritual care
Tailored Intervention
Procedure/SurgeryReceive tailored prescriptions and recommendations
Treatment groups
Trial outcomes
Primary outcomes
Adherence (feasibility)
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).
Secondary outcomes
Six minute walk test
Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).
Duke Activity Status Index
Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).
30-second sit to stand
Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).
Short physical performance battery
This objective assessment tool evaluates lower extremity functioning in frail older adults with good validity and reliability.\[100\] The three components are 1) static stance in 3 different positions, 2) usual gait speed, and 3) chair stand five times. The minimum detectable change indicates low sensitivity ranging 0.7-3.42. Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options: