- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02754427
Pilot Study for a Prospective Surveillance Program for Rehabilitation Following Surgery for Breast Cancer
23. oktober 2019 opdateret af: Kristin Campbell, University of British Columbia
Breast cancer treatment often results in long-term arm morbidity.
A prospective surveillance model with arm assessment pre-surgery followed by ongoing surveillance and targeted physiotherapy treatment after breast cancer surgery may improve early detection and management of arm morbidity.
This study aims to determine the effect of prospective surveillance to target physiotherapy on the prevalence of arm morbidity in the surveillance group compared to control group at 12-months after breast cancer surgery.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
41
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
30 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- age 30-75 years; receiving surgery for breast cancer, including those who will have immediate breast reconstruction.
Exclusion Criteria:
- prior breast cancer surgery; a pre-existing shoulder pathology on the side of breast surgery that limits shoulder range of motion <75% of non-affected side; or a diagnosis of primary lymphedema
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Prospective Surveillance Group
Women assigned to surveillance group were assessed for arm morbidity at pre-surgery and at 3, 6, and 9 months post-surgery.
If arm morbidity was detected at any time-point post-surgery, then a physiotherapy intervention was prescribed.
|
Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume.
Same assessment was repeated at 12 months post-surgery.
After surgery, participants randomized to the surveillance group underwent the same arm assessment at 3, 6, and 9 months post-surgery.
If arm morbidity was detected at any of those time points, then the participant was referred to individual physiotherapy treatment until the issue was resolved.
Andre navne:
|
Aktiv komparator: Education Group
Participants in the education group received the usual post-operative follow-up.
|
Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume.
Same assessment was repeated at 12 months post-surgery.
After surgery, participants randomized to the education group were asked to attend three patient education sessions on nutrition, stress management, and fatigue management of approximately 1 hour, delivered at 3, 6, and 9 months by study staff.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Shoulder Mobility
Tidsramme: 12 months
|
Arm morbidity due to decreased shoulder mobility was defined as ≥10% decrease in mobility from pre-surgery.
This was measured using a goniometer and evaluated the degrees of shoulder mobility in flexion, abduction and external rotation.
|
12 months
|
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Muscle Strength
Tidsramme: 12 months
|
Arm morbidity due to decreased upper body muscle strength was defined as ≥25% decrease in muscle strength from pre-surgery.
This was measured using a hand-held dynamometer and evaluated in kilograms.
|
12 months
|
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Function
Tidsramme: 12 months
|
Arm morbidity due to decreased upper body function was defined as ≥10 points decrease in function from pre-surgery.
This was measured using the Upper Extremity Functional Index that scores 0 to 80, with higher scores indicating greater level of function.
|
12 months
|
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Arm Volume
Tidsramme: 12 months
|
Arm morbidity due to increase in arm volume was defined as a ≥200 mL increase from pre-surgery.
Arm volume was measured using a perometer.
|
12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Kristin Campbell, PhD, kristin.campbell@ubc.ca
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
1. februar 2013
Primær færdiggørelse (Faktiske)
1. august 2015
Studieafslutning (Faktiske)
1. august 2015
Datoer for studieregistrering
Først indsendt
22. april 2016
Først indsendt, der opfyldte QC-kriterier
25. april 2016
Først opslået (Skøn)
28. april 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. oktober 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. oktober 2019
Sidst verificeret
1. oktober 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H12-01773
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Uafklaret
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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