Intensive Education in Increasing Understanding of Lymphedema in Patients With Breast Cancer Undergoing Surgery
Effect of Intensive Education on Breast Cancer Patient's Understanding of Lymphedema
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
PRIMARY OBJECTIVES:
I. To assess the patient's increased knowledge of lymphedema signs/symptoms after education.
SECONDARY OBJECTIVES:
I. The participant may detect lymphedema signs/symptoms at an early stage by having a pre-surgery comparison of bilateral upper extremities (BUE) circumferential measures to the 3 month post-surgery measures.
OUTLINE:
Participants complete a five question survey, designed by the Occupational Therapy staff, as an instrument to assess a patient's knowledge of lymphedema signs/symptoms before surgery. An Occupational Therapist (OT), Physical Therapist (PT), and/or Certified Lymphedema Therapist (CLT) provide written handouts to participants on the pathophysiology, signs, symptoms, and treatment of lymphedema. Participants repeat the survey at 3 months post-surgery. BUE circumferential measurements are also collected before surgery and at 3 months post-surgery.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Ohio
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Cleveland, Ohio, Forente stater, 44106-5065
- Case Comprehensive Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Participants will be diagnosed with breast cancer; the participants will be scheduled for a lumpectomy or a mastectomy at UH GMC Seidman Cancer Center
- They must understand written, verbal, and/or recorded survey questioning English
Exclusion Criteria:
- Individuals with previous radiation treatments to the breast or axilla areas
- Prior diagnosis of lymphedema
- Persons that do not speak English
- Those unwilling to participate in the follow-up call 3 months post-surgery
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Supportive care (lymphedema education)
In an educational intervention, participants complete a five question lymphedema survey, designed by the Occupational Therapy staff, as an instrument to assess a patient's knowledge of lymphedema signs/symptoms before surgery.
An OT, PT, and/or CLT provide written handouts to participants on the pathophysiology, signs, symptoms, and treatment of lymphedema.
Participants repeat the survey at 3 months post-surgery.
BUE circumferential measurements are also collected before surgery and at 3 months post-surgery.
|
Receive educational handouts
Andre navn:
Ancillary studies
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Improvement in participant's knowledge of lymphedema
Tidsramme: Baseline to 3 months post-surgery
|
Quantitative data regarding number of correct answers to the survey questions pre-surgery and at the post-surgery 3 month re-test will be compared to assess if the lymphedema education improved the participant's knowledge of lymphedema.
|
Baseline to 3 months post-surgery
|
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Total girth differences as assessed by BUE circumferential measurements using the National Lymphedema Network (NLN) guidelines
Tidsramme: Baseline to 3 months post-surgery
|
If a > 2 cm difference is noted in girth from pre to post surgery measures, a referral will be forwarded to the physician by the study investigators and treatment options provided to the participant.
|
Baseline to 3 months post-surgery
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Dotti Thompson, Case Comprehensive Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CASE1113
- P30CA043703 (U.S. NIH-stipend/kontrakt)
- NCI-2014-00348 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- CASE 1113 (Annen identifikator: Case Comprehensive Cancer Center)
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