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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01829984
• Other study ID #: 13-057
• Status: Completed
• Phase: N/A
• First received: April 9, 2013
• Last updated: September 3, 2015
• Start date: April 2013
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Verbal and Written Instruction
Pre-teaching Evaluation: Patient Pre-teaching Evaluation: Caregiver o 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.
• Verbal and Written Plus Simulation
Post-injection Evaluation: Patient Post-injection Evaluation: Caregiver o 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Assess for changes in patient self-reported	worry about injection before and after the injection teaching	1 year	No
Secondary	Compare nurses' perceptions of patient/caregiver confidence levels	after injection teaching to actual patient/caregiver reported confidence levels	1 year	No
Secondary	Compare the amount of nurses' time spent teaching	between the teaching modalities	1 year	No

External Links

•   Memorial Sloan-Kettering Cancer Center