Verbal and Written Instruction Versus Verbal and Written Plus Simulation in Patients With Breast Cancer and Their Caregivers
- Conditions
- Breast Cancer
- Interventions
- Other: Verbal and Written InstructionOther: Verbal and Written Plus Simulation
- Registration Number
- NCT01829984
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- 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.
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description control injection teaching Verbal and Written Instruction 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. intervention group Verbal and Written Plus Simulation 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.
- Primary Outcome Measures
Name Time Method compare verbal and written teaching for injection teaching 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 Outcome Measures
Name Time Method Assess for changes in patient self-reported 1 year worry about injection before and after the injection teaching
Compare the amount of nurses' time spent teaching 1 year between the teaching modalities
Compare nurses' perceptions of patient/caregiver confidence levels 1 year after injection teaching to actual patient/caregiver reported confidence levels
Trial Locations
- Locations (1)
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States