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Completed

NCT Number: NCT01829984

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Verbal and Written Instruction

Other

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

Other

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.

Primary outcomes

  1. compare verbal and written teaching for injection teaching

    Time frame: 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 outcomes

  1. Assess for changes in patient self-reported

    Time frame: 1 year

    worry about injection before and after the injection teaching

  2. Compare nurses' perceptions of patient/caregiver confidence levels

    Time frame: 1 year

    after injection teaching to actual patient/caregiver reported confidence levels

  3. Compare the amount of nurses' time spent teaching

    Time frame: 1 year

    between the teaching modalities

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 11, 2013
Registry last updated
Sep 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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