IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer (IMPROVE-B)

Penn State Health

Status: Completed

Conditions: Breast Cancer; Physical Activity; Surgery; Prehabilitation

Treatments: Behavioral: Prehabilitation Education; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03498157

PSCI # 17-051

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Partly Supervised Prehabilitation

Experimental group

Description:

Will be offered an initial one week (5 days for 3 hours each) supervised exercise prehabilitation program including a two hour group-based prehabilitation class at Penn State Rehabilitation Hospital, Hummelstown. The following weeks till surgery the learned exercise program should be done home-based for 5 times a week. A weekly phone call during this period will help to support and adapt the exercise program.

Treatment:

Behavioral: Prehabilitation Education

Behavioral: Exercise

Home-based Prehabilitation

Active Comparator group

Description:

Will be offered an individual one-on-one appointment for an exercise introduction session with an exercise and cancer specialist and weekly phone calls to support and adapt the exercise program. The exercises should be done home-based for 5 times a week until the time of surgery. Furthermore, a two hour group-based prehabilitation class at the Penn State Hershey Cancer Institute will be offered.

Treatment:

Behavioral: Prehabilitation Education

Behavioral: Exercise

Control Group

Active Comparator group

Description:

Will be offered a two hour group-based prehabilitation class at the Penn State Hershey Cancer Institute.

Treatment:

Behavioral: Prehabilitation Education

Comparison group- women too active

No Intervention group

Description:

Added comparison group: Women who are ineligible on the basis of 'engaging in systematic intense exercise training (at least 1h twice a week) will be recruited to complete measures only, with no randomization