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

NCT ID: NCT01829984

Last Updated: 2015-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-09-30

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

control injection teaching

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.

Verbal and Written Instruction

Intervention Type: 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.

intervention group

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.

Verbal and Written Plus Simulation

Intervention Type: 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.

Interventions

Verbal 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.

Intervention Type: OTHER

Verbal 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erica Fischer-Cartlidge, RN, MSN

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org/

Memorial Sloan-Kettering Cancer Center

Other Identifiers

13-057

Identifier Type: -

Identifier Source: org_study_id