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Moving On - An RCT to Test Physical Therapy Education

Moving On - A Randomized Controlled Trial for Acceptability and Feasibility of an Early Physical Therapy Education Intervention for Breast Cancer Surgical Candidates

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04731805
Enrollment
50
Registered
2021-02-01
Start date
2012-05-23
Completion date
2015-05-22
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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.

Detailed 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.

Interventions

Patient education intervention that is evidence-based, physical therapy, patient & family centered through the use of face to face instruction, a booklet, and therapeutic exercise DVD. The education materials are designed to deliver information on short term, long term, and late physical and functional effects of breast cancer treatment and given to breast cancer survivors before beginning cancer treatment. The education materials are designed to be used before, during, and after breast cancer treatment.

Sponsors

American Physical Therapy Association
CollaboratorOTHER
Northeastern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Randomized controlled trial, longitudinal and prospective

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in active shoulder range of motion3 monthsActive shoulder range of motion is measured with a standard goniometer in degrees. Change from baseline to 3 months for shoulder flexion, extension, abduction, and internal and external ranges are measured.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026