Moving On - An RCT to Test Physical Therapy Education

NCT ID: NCT04731805

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-23

Study Completion Date

2015-05-22

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial, longitudinal and prospective
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Moving On After Breast Cancer - Intervention Arm

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.

Group Type EXPERIMENTAL

Moving On After Breast Cancer

Intervention Type 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.

Usual Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Moving On After Breast Cancer

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Intervention arm

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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American Physical Therapy Association

OTHER

Sponsor Role collaborator

Northeastern University

OTHER

Sponsor Role lead

Responsible Party

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Ann Marie Flores

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ann M Flores, PhD

Role: PRINCIPAL_INVESTIGATOR

Northeastern University

References

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Warren C. Physical therapy intervention suggestions for women following breast cancer surgery. Journal of Women's Health Physical Therapy. 2005;29(1):21-24.

Reference Type BACKGROUND

Mustian KM, Peppone L, Darling TV, Palesh O, Heckler CE, Morrow GR. A 4-week home-based aerobic and resistance exercise program during radiation therapy: a pilot randomized clinical trial. J Support Oncol. 2009 Sep-Oct;7(5):158-67.

Reference Type BACKGROUND
PMID: 19831159 (View on PubMed)

McNeely ML, Campbell K, Ospina M, Rowe BH, Dabbs K, Klassen TP, Mackey J, Courneya K. Exercise interventions for upper-limb dysfunction due to breast cancer treatment. Cochrane Database Syst Rev. 2010 Jun 16;(6):CD005211. doi: 10.1002/14651858.CD005211.pub2.

Reference Type BACKGROUND
PMID: 20556760 (View on PubMed)

Torres Lacomba M, Yuste Sanchez MJ, Zapico Goni A, Prieto Merino D, Mayoral del Moral O, Cerezo Tellez E, Minayo Mogollon E. Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial. BMJ. 2010 Jan 12;340:b5396. doi: 10.1136/bmj.b5396.

Reference Type BACKGROUND
PMID: 20068255 (View on PubMed)

Schmitz KH, Ahmed RL, Troxel A, Cheville A, Smith R, Lewis-Grant L, Bryan CJ, Williams-Smith CT, Greene QP. Weight lifting in women with breast-cancer-related lymphedema. N Engl J Med. 2009 Aug 13;361(7):664-73. doi: 10.1056/NEJMoa0810118.

Reference Type BACKGROUND
PMID: 19675330 (View on PubMed)

Other Identifiers

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12-04-17

Identifier Type: -

Identifier Source: org_study_id

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