Moving On - An RCT to Test Physical Therapy Education
28. januar 2021 opdateret af: Ann Marie Flores, Northeastern University
"Moving On" - A Randomized Controlled Trial for Acceptability and Feasibility of an Early Physical Therapy Education Intervention for Breast Cancer Surgical Candidates
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
50
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
21 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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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.
Andre navne:
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Ingen indgriben: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in active shoulder range of motion
Tidsramme: 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.
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3 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ann M Flores, PhD, Northeastern University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Warren C. Physical therapy intervention suggestions for women following breast cancer surgery. Journal of Women's Health Physical Therapy. 2005;29(1):21-24.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
23. maj 2012
Primær færdiggørelse (Faktiske)
22. maj 2015
Studieafslutning (Faktiske)
22. maj 2015
Datoer for studieregistrering
Først indsendt
24. januar 2021
Først indsendt, der opfyldte QC-kriterier
28. januar 2021
Først opslået (Faktiske)
1. februar 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. februar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. januar 2021
Sidst verificeret
1. januar 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 12-04-17
Plan for individuelle deltagerdata (IPD)
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