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

A Comparison of Strategies for Injection Teaching: Verbal and Written Instruction Versus Verbal and Written Plus Simulation in Patients With Breast Cancer and Their Caregivers

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Verbal and Written Instruction; Other: Verbal and Written Plus Simulation

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All breast cancer medical oncology clinics at MSKCC will serve as recruitment clinics for the proposed study. Nurses will notify the PI of any patient due to start adjuvantadjuvant or neoadjuvant treatment when the regimen includes pegfilgrastim.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control injection teaching; The first 25 subjects recruited into the study will be that control group. Subjects accrued during the control phase will receive the control injection teaching, which at MSKCC is verbal instruction. To minimize practice variation, the teaching will be provided by the office-practice nurse guided by a verbal script. The consented subjects will complete a questionnaire before the teaching, immediately after the teaching, and after performing the injection the following day. The nurse who administered the teaching will also complete an evaluation immediately following the teaching.	Other: Verbal and Written Instruction; Pre-teaching Evaluation: Patient; Pre-teaching Evaluation: Caregivero To be completed immediately before the teaching. Administered by the nurse who will provide the teaching. The form utilized will depend on if the patient or caregiver will be administering the injection.; Post-teaching Evaluation: Patient Post-teaching Evaluation: Caregiver To be completed immediately after the teaching. Administered by the nurse who provided the teaching. The form utilized will depend on if the patient or caregiver will be administering the injection.
intervention group; The subsequent 25 subjects enrolled into the study will be in the intervention group. Subjects accrued during the intervention phase will receive the verbal and written injection teaching, plus demonstration and return demonstration using an injection model. It is anticipated that the intervention teaching will take no longer then 5 additional minutes, however time will be evaluated as a secondary objective as well in both groups. The consented subjects will complete a questionnaire before the teaching, immediately after the teaching, and after performing the injection the following day. The nurse who administered the teaching will also complete an evaluation immediately following the teaching.	Other: Verbal and Written Plus Simulation; Post-injection Evaluation: Patient; Post-injection Evaluation: Caregivero To be completed after the injection is administered (outside of MSKCC) by the patient or caregiver. The form utilized will depend on if the patient or caregiver has administered the injection. They will return this evaluation at the patient's next visit (2 weeks later).; Nurse Evaluation: Control; Nurse Evaluation: Model o To be completed immediately following the completion of the teaching by the nurse. The form utilized will depend on if the teaching was part of the control or intervention phase of the study.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Erica Fischer-Cartlidge, RN, MSN, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan-Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: April 9, 2013
• First Submitted That Met QC Criteria: April 9, 2013
• First Posted (Estimate): April 11, 2013

Study Record Updates

• Last Update Posted (Estimate): September 4, 2015
• Last Update Submitted That Met QC Criteria: September 3, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Injection Teaching; 13-057
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 13-057