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Protocol Summary


Protocol No.
PSCI-17-051
Prinicipal Investigator
Schmitz, Kathryn
Phase
NA
Age Group
Adult
Scope
Local
Title
Impact of Prehabilitation in Oncology Via Exercise - Breast Cancer
Objective
Our primary aim is to assess safety, feasibility, and acceptability of prehabilitative (pre-treatment) exercise in breast cancer patients. These will be defined as follows:

Safety: Data from the primary investigators? prior trials indicate that we could expect up to 25% of the participants to experience a musculoskeletal impairment that would be mild (e.g., not require treatment alterations). We also expect an injury rate of 5% for musculoskeletal injuries (defined as symptoms lasting a week or longer and or requiring the attention of a medical professional).
Feasibility: We will consider the intervention feasible if 50% of included patients actually do at least half of the exercise sessions prescribed for 2 weeks or more.
Acceptability: We will consider the intervention to be acceptable if more than 50% of the patients approached agree to receive at least the first exercise session.

1.3 Secondary Study Endpoints
Breast cancer-related symptoms (via revised version of the ESAS-r and EORTC QLQ-BR23), Quality of life (via EORTC QLQ-C30), fatigue (via MFI-20), mood, sleep (via PSQI), physical function (various assessments), treatment-related complications (via the medical record or questionnaires; e.g. onset of lymphedema, pain, impaired shoulder mobility), physical activity behavior (SQUASH) and uptake of post-treatment rehabilitation measures post primary cancer treatment

Applicable Disease Sites
Breast - Female
Status
Open
Participating Institutions
Hershey Medical Center