Moving On - An RCT to Test Physical Therapy Education

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moving On After Breast Cancer

Behavioral

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.

Other names: Intervention arm

Primary outcomes

Change in active shoulder range of motion

Time frame: 3 months

Active 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.

Sponsors and collaborators

Lead sponsor

Northeastern University

Other

Collaborators

American Physical Therapy Association

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Feb 1, 2021
Registry last updated: Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed