Breast Carcinoma
Conditions
Brief summary
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.
Detailed description
PRIMARY OBJECTIVES: I. Determine feasibility based on exercise as evaluated by adherence (\> 70%). II. Assess feasibility of nutrition and mind/spirit practice by measuring adherence (\> 70% of enrolled patients for the preoperative study period). SECONDARY OBJECTIVES: I. Evaluate physical measures: six minute walk test, Duke Activity Status Index, 30-second sit to stand, Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Function Brief 3 Dimensional (3D) Profile, body composition, and Quick Disabilities of Arm, Shoulder, and Hand (QuickDASH). II. Assess exercise behavior measures: Godin Leisure-Time Physical Activity and Exercise Intent Questionnaire, self-reported exercise activity and future intent, self-efficacy for home exercise programs. III. Evaluate malnutrition risk with Malnutrition Screening Tool. IV. Assess psychological and spiritual distress with relevant measures within the Edmonton Symptom Assessment Scale- Financial and Spiritual Distress (ESAS-FS) and European Quality of Life 5 Dimensions (EQ-5D-5L). V. Evaluate symptom burden with ESAS-FS and health-related quality of life with EQ-5D-5L. EXPLORATORY OBJECTIVES: I. Evaluate disease outcomes as measured by relative dose intensity and pathologic complete response. II. Assess cancer treatment timing by examining time from diagnosis to surgery, time from last chemotherapy cycle to surgery, time from surgery to adjuvant treatment, hospitalizations and length of stay. III. Evaluate cancer treatment complications measured by the incidence of chemotherapy-induced peripheral neuropathy (using Common Terminology Criteria for Adverse Events \[CTCAE\] 5.0). IV. Identify future program improvements via enrollment rate, adherence to prescribed nutrition and mental health interventions assessed via weekly logs, a participant feedback survey, clinician feedback survey, reasons for non-participation, challenges to intervention adherence, and days to consult completion. V. Document the utilization of multidisciplinary specialty services. OUTLINE: Patients attend cancer physiatry consultations over 1 hour prior to surgery on days 0 and 42, as-needed after day 42 but prior to surgery, and then on day 168 following surgery. At consultation visits, patients receive prehabilitation education and tailored recommendations for a multimodal home-based program consisting of aerobic exercise, resistance exercise, nutrition, and psychospiritual care. Patients are recommended to participate in 30 minutes of light intensity aerobic exercise on "bad days" during chemotherapy and at least 30 minutes three times per week at moderate intensity on "good days" during chemotherapy. If patients complete chemotherapy, they are recommended to participate in 30 minutes of moderate intensity or 15 minutes of vigorous intensity exercise 5-10 times per week. Patients are also recommended to participate in resistance exercise 2-3 times per week, with a rest day between each session during and after completion of chemotherapy. Patients receive nutritional guidance regarding protein intake and are encouraged to consume 3-4 portions per day, ideally within 1 hour of exercise. Patients also receive recommendations for psychospiritual skills to practice, with a goal of practicing one skill or activity daily. Patients receive educational materials containing practical tips and resources for sleep hygiene, energy conservation, and maintenance of physical mobility during hospitalization. Patients may receive additional referrals to physical therapy, occupational therapy, registered dietitian, and/or clinical social work as needed.
Interventions
OTHERAerobic Exercise
Participate in aerobic exercise
PROCEDUREBioelectric Impedance Analysis
Ancillary studies
OTHERConsultation
Attend physiatry consultation
OTHEREducational Intervention
Receive prehabilitation education
OTHERElectronic Health Record Review
Ancillary studies
OTHERNutritional Intervention
Receive nutritional guidance
OTHERPhysical Performance Testing
Ancillary studies
BEHAVIORALPsychosocial Care
Receive psychospiritual care
OTHERQuestionnaire Administration
Ancillary studies
OTHERReferral
Receive referral(s)
OTHERResistance Training
Participate in resistance exercise
PROCEDURESpiritual Therapy
Receive psychospiritual care
PROCEDURETailored Intervention
Receive tailored prescriptions and recommendations
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence (feasibility) | Up to day 168 | 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
| Measure | Time frame | Description |
|---|---|---|
| Six minute walk test | At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]) | 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 | At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]) | 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 | At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]) | 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 | At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]) | 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). |
| Patient Reported Outcomes Measurement Information System Cancer Function Brief 3-dimensional Profile | At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]) | 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). |
| Body composition: Body composition measures, including but not limited to fat-free mass | At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]) | 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). |
| Quick Disabilities of Arm, Shoulder, and Hand | At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]) | 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). |
| Godin Leisure-Time Physical Activity and Exercise Intent Questionnaire: | At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]) | Godin Leisure-Time Physical Activity and Exercise Intent this questionnaire (estimated completion time of one minute) consists of 6 self-administered questions about the number of light (minimal effort), moderate (not exhausting), and strenuous (heart beats rapidly) 15-minute bouts of leisure time physical activity (LTPA) in a typical 7-day period. 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). |
| Self-reported exercise-Survey | At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]) | 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). |
| Intent to exercise- Survey | At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]) | 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). |
| Self-Efficacy for Home Exercise Programs | At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]) | This is a 12-question patient-reported outcome measure based on the Self-Efficacy for Exercise (SEE) scale. 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). |
| Malnutrition Screening Tool | At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]) | This is a 2-question measure that is endorsed by the Academy of Nutrition and Dietetics for use in adults regardless of age, medical history, or setting. 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). |
| Edmonton Symptom Assessment Scale - Financial and Spiritual Distress | At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]) | 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). |
| European Quality of Life 5 Dimensions | At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]) | 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). |
| Body composition: Body composition measures, including fat mass | At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]) | 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). |
| Body composition: Body composition measures, including phase angle | At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]) | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJessica Cheng
City of Hope Medical Center
Outcome results
None listed