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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Verbal and Written Instruction; Other: Verbal and Written Plus Simulation

Study type: Observational

Funder types: Other

Identifiers

NCT01829984

13-057

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

51 participants in 2 patient groups

control injection teaching

Description:

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.

Treatment:

Other: Verbal and Written Instruction

intervention group

Description:

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.

Treatment:

Other: Verbal and Written Plus Simulation