IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer

Milton S. Hershey Medical Center32 enrolled

Overview

The purpose of this study is to determine whether patients are able to participate in a so called prehabilitation program (prior to the beginning of cancer treatment) which includes (1) a supervised and home-based exercise program plus one educational session or (2) just home-based exercise plus one educational session or (3) just one educational session. Breast cancer surgery may have potential for several side effects, including functional (e.g. flexibility in the affected arm, lymphedema \[swelling that generally occurs in the arms or legs that occurs as a result of the removal of or damage to lymph nodes as a part of cancer treatment\], shoulder pain) and psychosocial (e.g. reduced quality of life, increased fatigue) aspects. Evidence shows that exercise is considered to be an effective treatment approach in breast cancer patients during and after treatment with regard to the above mentioned side-effects. Also, prehabilitative exercise in colon and lung cancer patients was shown as feasible and effective. However, no experience exits with regard to prehabilitation exercise in breast cancer patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Breast Cancer Prehabilitation Physical Activity

Interventions

ExerciseBEHAVIORAL

The exercise intervention is an at least 2 weeks lasting (till the day surgery is taking place) 5-times weekly resistance training intervention combined with aerobic exercise (mostly walking).

Prehabilitation EducationBEHAVIORAL

Participate will receive a 2 hour group-based prehabilitation class which will be held at the Penn State Cancer Institute, Hershey

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy * Not metastatic (stage \<4) * Females and males ≥18 years of age * Fluent in written and spoken English * Must be able to provide and understand informed consent * Must have an ECOG PS of ≤ 2 * Scheduled for lump- or mastectomy at Penn State Cancer Institute * ≥ 2 weeks till primary treatment * Primary attending surgeon approval Exclusion Criteria: * Receiving neoadjuvant chemotherapy, radiotherapy or hormone therapy * Not fluent in written and spoken English * Evidence in the medical record of an absolute contraindication (e.g. Heart insufficiency \> NYHA III or uncertain arrhythmia; uncontrolled hypertension; severe renal dysfunction (GFR \< 30%, Creatinine\> 3mg/dl; insufficient hematological capacity like either hemoglobin value below 8 g/dl or thrombocytes below 30.000/µL; reduced standing or walking ability) for exercise * Pregnant women * Engaging in systematic intense exercise training (at least 1h twice per week)

Locations (1)

Penn State Cancer Institute

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

Safety of the exercise intervention (assessed by standardized questionnaire)

Within the questionnaire we will assess whether musculoskeletal occur (yes/no; ongoing; location; severity (mild-life threatening); daily activities affected). The intervention will be considered as safe if less than 25% of included patients report mild musculoskeletal impairments and less than 5% experienced musculoskeletal injuries (defined as symptoms lasting a week or longer and or requiring the attention of a medical professional).

Time frame: Through study intervention, an average of 3 weeks

Feasibility of the exercise intervention (assessed via exercise logs)

The exercise intervention will be considered feasible if 50% of included patients actually do at least half of the exercise sessions prescribed for 2 weeks or more.

Time frame: Through study intervention, an average of 3 weeks

Acceptability of the exercise intervention (assessed via patient flow diagram)

The intervention will be considered acceptable if more than 50% of the patients randomized to the control group agree to receive at least the first exercise session.

Time frame: During Recruitment till first intervention is delivered (with one week after enrolment)

Secondary Outcomes

Health-Related Quality of Life: EORTC QLQ-C30, version 3.0

QoL will be assessed with the validated 30-item self-assessment questionnaire of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30, version 3.0).