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

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ClinicalTrials.gov Identifier: NCT01829984
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : September 4, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Breast Cancer Other: Verbal and Written Instruction Other: Verbal and Written Plus Simulation

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Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : April 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: 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 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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829984


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Erica Fischer-Cartlidge, RN, MSN Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01829984    
Other Study ID Numbers: 13-057
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: September 4, 2015
Last Verified: September 2015
Keywords provided by Memorial Sloan Kettering Cancer Center:
Injection Teaching
13-057
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases