Moving On - An RCT to Test Physical Therapy Education

Northeastern University

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Moving On After Breast Cancer

Study type: Interventional

Funder types: Other

Identifiers

NCT04731805

12-04-17

Details and patient eligibility

About

The purpose of this study is to test the acceptability, feasibility and explore the possible effects of an early physical therapy education intervention for breast cancer survivors.

Full description

This study uses a randomized controlled and longitudinal study design. We will compare two groups - an intervention group and a control group - to test the effects of an early physical therapy education intervention for breast cancer survivors who are candidates for breast cancer surgery. Because of the nature of the intervention (patient early education with 1:1 discussion of educational materials) we will be unable to introduce blinding of the participant as well as the staff.

Enrollment: 50 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed with unilateral breast cancer
• Candidate for breast cancer surgery as first line of cancer treatment
• Undergo breast cancer surgery at Brigham and Woman's Hospital, Boston, Massachusetts
• Female
• English speaking
• Greater than or equal to 21 years old

Exclusion criteria

• Previous history of breast cancer and/or recurrent/metastatic disease
• Receiving neoadjuvant chemotherapy treatment
• Bilateral breast cancer
• History of shoulder impairments or severe upper quarter scarring
• Pregnancy
• Central nervous system damage
• Dementia
• History of other previous cancers (except non-melanoma skin)
• Systemic medical conditions (e.g.: fibromyalgia, rheumatoid arthritis, etc.)
• Amputation of either upper extremity

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Moving On After Breast Cancer - Intervention Arm

Experimental group

Description:

Participants are randomized to the intervention arm after their breast cancer diagnosis (but before cancer surgery) and baseline measurements (T0) are taken. They are followed up again at 2 weeks after their breast cancer surgery (T1), and again at 3 months after surgery (T2). Participants are given the patient education materials (booklet, therapeutic exercise DVD, small ball, range of motion wand). The research assistant orients the participant to the education materials and summarizes each section of the booklet. The research assistant also teaches the participant how to do the therapeutic exercises in the booklet. All participants in the intervention also receive usual care.

Treatment:

Behavioral: Moving On After Breast Cancer

Usual Care

No Intervention group

Description:

Participants are randomized to the usual care arm after their breast cancer diagnosis (but before cancer surgery) and baseline measurements (T0) are taken. They are followed up again at 2 weeks after their breast cancer surgery (T1), and again at 3 months after surgery (T2). Usual care consists of pre-operative testing, pre-operative nursing education on care of the surgical incision and pain management followed by breast cancer surgery.