Verbal and Written Instruction Versus Verbal and Written Plus Simulation in Patients With Breast Cancer and Their Caregivers

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01829984
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to compare two different ways of teaching people how to give injections at home. The first is what we do now, which is teaching patients and/or their caregivers verbally and by giving written instructions. The second is what we do now (verbal and written instructions) along with a demonstration and practice using a needle and an injection pad that feels similar to skin and fat. This is being done to find the best method for teaching people to give an injection at home.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-09
• Study First Posted: 2013-04-11
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-03
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• English speaking
• Over 18 years of age
• No history of performing injections
• Patient must be receiving pegfilgrastim during adjuvant or neoadjuvant chemotherapy
• Patient will have the pegfilgrastim administered at home either by self administering or by a caregiver.

Exclusion Criteria

• Patient or caregiver desire to inject (with saline) during or immediately following the injection teaching
• Prior self-injection or injection administration experience of any type
• Patients with history of anaphylaxis or other severe reactions to latex
• Patients that required pegfilgrastim injection be administered in clinic

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
compare verbal and written teaching for injection teaching	1 year	with verbal and written teaching + simulation using an injection model, in terms of: * Patient/caregiver satisfaction; * Patient/caregiver self-confidence; * Nurse satisfaction

Secondary Outcome Measures

Name	Time	Method
Assess for changes in patient self-reported	1 year	worry about injection before and after the injection teaching
Compare the amount of nurses' time spent teaching	1 year	between the teaching modalities
Compare nurses' perceptions of patient/caregiver confidence levels	1 year	after injection teaching to actual patient/caregiver reported confidence levels

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States