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

NCT07819981 | Not Yet Recruiting DMC

• 3 other identifiers: 24284NCI-2026-05688P30CA033572
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to day 168

Secondary Outcomes (16)

• 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])

• 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])

• 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])

• 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])

• 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])

Study Arms (1)

Supportive care (prehabilitation)

EXPERIMENTAL

See Detailed Description.

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

Interventions

Aerobic Exercise OTHER

Participate in aerobic exercise

Also known as: Aerobic Activity

Supportive care (prehabilitation)

Bioelectric Impedance Analysis PROCEDURE

Ancillary studies

Also known as: BIA, Bioelectric Impedance, Bioelectric Impedance Test, Bioelectrical Impedance Analysis, Bioimpedance Analysis

Supportive care (prehabilitation)

Consultation OTHER

Attend physiatry consultation

Also known as: Consult

Supportive care (prehabilitation)

Educational Intervention OTHER

Receive prehabilitation education

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Supportive care (prehabilitation)

Electronic Health Record Review OTHER

Ancillary studies

Supportive care (prehabilitation)

Nutritional Intervention OTHER

Receive nutritional guidance

Supportive care (prehabilitation)

Physical Performance Testing OTHER

Ancillary studies

Also known as: Physical Fitness Testing, Physical Function Testing

Supportive care (prehabilitation)

Psychosocial Care BEHAVIORAL

Receive psychospiritual care

Also known as: Psychosocial Support

Supportive care (prehabilitation)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (prehabilitation)

Referral OTHER

Receive referral(s)

Also known as: Referred

Supportive care (prehabilitation)

Resistance Training OTHER

Participate in resistance exercise

Also known as: Strength Training

Supportive care (prehabilitation)

Spiritual Therapy PROCEDURE

Receive psychospiritual care

Supportive care (prehabilitation)

Tailored Intervention PROCEDURE

Receive tailored prescriptions and recommendations

Supportive care (prehabilitation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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 workers who do not interact with study participants and therefore cannot provide relevant feedback

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise; Referral and Consultation; Early Intervention, Educational; Educational Status; Methods; Exercise Test; Psychiatric Rehabilitation; Resistance Training; Spiritual Therapies

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Professional Practice; Organization and Administration; Health Services Administration; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Rehabilitation; Therapeutics; Exercise Therapy; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities; Physical Conditioning, Human; Complementary Therapies

Study Officials

• Jessica Cheng

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: September 15, 2026
• Study Start (Estimated): February 24, 2027
• Primary Completion (Estimated): July 24, 2029
• Study Completion (Estimated): July 24, 2029
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

US (2)