Prehabilitation for Improving Outcomes in Breast Cancer Patients Undergoing Neoadjuvant Systemic Treatment and Surgery

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.

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