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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01829984
Enrollment
51
Registered
2013-04-11
Start date
2013-04-30
Completion date
2015-09-30
Last updated
2015-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Injection Teaching, 13-057

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.

Interventions

OTHERVerbal 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.

OTHERVerbal 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.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
compare verbal and written teaching for injection teaching1 yearwith verbal and written teaching + simulation using an injection model, in terms of: * Patient/caregiver satisfaction * Patient/caregiver self-confidence * Nurse satisfaction

Secondary

MeasureTime frameDescription
Assess for changes in patient self-reported1 yearworry about injection before and after the injection teaching
Compare nurses' perceptions of patient/caregiver confidence levels1 yearafter injection teaching to actual patient/caregiver reported confidence levels
Compare the amount of nurses' time spent teaching1 yearbetween the teaching modalities

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026