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
Sponsor study identifier
observational
51
1 country
1
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2015
Actual (reported)Study Completion
September 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2015
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
April 9, 2013
Actual (reported)April 11, 2013
Actual (reported)September 2015
Actual (reported)September 2015
Actual (reported)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
Assess for changes in patient self-reported
1 year
Compare nurses' perceptions of patient/caregiver confidence levels
1 year
Compare the amount of nurses' time spent teaching
1 year
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.
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.
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.
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.
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Erica Fischer-Cartlidge, RN, MSN
Memorial Sloan Kettering Cancer Center
51 participants (actual enrollment reported by the registry).
First Submitted
April 9, 2013
First Posted
April 11, 2013
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions
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.
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Primary Completion
September 2015
Actual (reported)Study Completion
September 2015
Actual (reported)Last Updated
September 4, 2015
Record last verified: 2015-09
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Source: ClinicalTrials.gov.
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