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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Aerobic Exercise

    Other intervention

    Participate in aerobic exercise

  • Bioelectric Impedance Analysis

    Procedure/Surgery

    Ancillary studies

  • Consultation

    Other intervention

    Attend physiatry consultation

  • Educational Intervention

    Other intervention

    Receive prehabilitation education

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Nutritional Intervention

    Other intervention

    Receive nutritional guidance

  • Physical Performance Testing

    Other intervention

    Ancillary studies

  • Psychosocial Care

    Behavioral

    Receive psychospiritual care

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Referral

    Other intervention

    Receive referral(s)

  • Resistance Training

    Other intervention

    Participate in resistance exercise

  • Spiritual Therapy

    Procedure/Surgery

    Receive psychospiritual care

  • Tailored Intervention

    Procedure/Surgery

    Receive tailored prescriptions and recommendations

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Supportive care (prehabilitation)Experimental treatment 13 interventions

Trial outcomes

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).

Time frame
Up to day 168

Secondary outcomes

1

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).

Time frame
At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])
2

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).

Time frame
At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])
3

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).

Time frame
At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])
4

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).

Time frame
At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])

Other outcomes

Sponsors and contacts

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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: