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Single arm study for Breast Cancer (iPIVAP Trial)

N/A
Waitlist Available
Led By Deborah H Allen, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years.
Awards & highlights

iPIVAP Trial Summary

This trial will study staff attitudes towards a new practice of inserting IVs on the same side as lymph node removal.

Eligible Conditions
  • Breast Cancer
  • Lung Cancer
  • Melanoma
  • Lymphedema

iPIVAP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Identify facilitators and barriers that impact staff uptake for implementation of practice change involving ipsilateral IV insertion in patients with axillary lymphadenectomy/dissection.
Secondary outcome measures
Lymphedema symptoms; patient reported outcomes (PRO)
Lymphedema
Study participation acceptance
+1 more

iPIVAP Trial Design

1Treatment groups
Experimental Treatment
Group I: Single arm studyExperimental Treatment1 Intervention
Patients with a history of axillary surgical lymph node procedures (SLNP) presenting for routine radiographic scan will complete baseline measures: bilateral volumetric measurements and self-reported symptoms. Patients will undergo SOC contralateral arm intravenous access attempt. After one failed attempt, ipsilateral intravenous access instead of pedal or neck access will be offered per research protocol. Nursing documentation will reflect the failed venipuncture and categorize a reason for the failed attempt.

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Who is running the clinical trial?

Duke UniversityLead Sponsor
2,381 Previous Clinical Trials
3,427,710 Total Patients Enrolled
54 Trials studying Breast Cancer
10,217 Patients Enrolled for Breast Cancer
Deborah H Allen, PhDPrincipal InvestigatorDuke Health
1 Previous Clinical Trials
25 Total Patients Enrolled
~1 spots leftby Jun 2025
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