Assessment of the Effectiveness of Chemotherapy Teaching: BrUOG 258

This study has been completed.
Sponsor:
Collaborators:
Rhode Island Hospital
The Miriam Hospital
Fatima Memorial Hospital
Roger Williams Medical Center
Lifespan
Information provided by (Responsible Party):
Dr Anthony Mega, Brown University
ClinicalTrials.gov Identifier:
NCT01827761
First received: April 4, 2013
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

This study will evaluate whether chemotherapy teaching sessions improves patient's knowledge, preparedness and anxiety in relation to chemotherapy. This study will also evaluate the effect of age, race, native language, education level, type of cancer and chemotherapy regimen on the oncology teaching session.


Condition Intervention
Cancer
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Effectiveness of Chemotherapy Teaching: BrUOG 258

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Evaluate whether chemotherapy teaching sessions improves patient's knowledge, preparedness and anxiety in relation to chemotherapy [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]

    To evaluate whether chemotherapy teaching sessions improves patient's knowledge, preparedness and anxiety in relation to chemotherapy

    After informed consent for this study is obtained, patients will be given questionnaire #1 that includes rating their knowledge of the side effects of treatment, their understanding of the treatment schedule, what do in the event of complication, how to reach the medical team and an assessment of the level of anxiety. The questionnaire will be repeated at day 1 of the first chemotherapy treatment to assess the effectiveness of the teaching session. In addition, questionnaire #3 will be administered at day 1 of cycle 2 of their first chemotherapy.



Secondary Outcome Measures:
  • Compare changes in patient's knowledge, preparedness and anxiety in relation to chemotherapy teaching sessions [ Time Frame: every 6 months up to two years ] [ Designated as safety issue: No ]
    To compare changes in patient's knowledge, preparedness and anxiety in relation to chemotherapy teaching sessions between participating Brown University Oncology Research Group Hospitals After informed consent for this study is obtained, patients will be given questionnaire #1 that includes rating their knowledge of the side effects of treatment, their understanding of the treatment schedule, what do in the event of complication, how to reach the medical team and an assessment of the level of anxiety. The questionnaire will be repeated at day 1 of the first chemotherapy treatment to assess the effectiveness of the teaching session. In addition, questionnaire #3 will be administered at day 1 of cycle 2 of their first chemotherapy.


Enrollment: 196
Study Start Date: October 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Questionnaire
After informed consent for this study is obtained, patients will be given questionnaire #1 that includes rating their knowledge of the side effects of treatment, their understanding of the treatment schedule, what do in the event of complication, how to reach the medical team and an assessment of the level of anxiety. The questionnaire will be repeated at day 1 of the first chemotherapy treatment to assess the effectiveness of the teaching session. In addition, questionnaire #3 will be administered at day 1 of cycle 2 of their first chemotherapy.
Behavioral: Questionnaire
After informed consent for this study is obtained, patients will be given questionnaire #1 that includes rating their knowledge of the side effects of treatment, their understanding of the treatment schedule, what do in the event of complication, how to reach the medical team and an assessment of the level of anxiety. The questionnaire will be repeated at day 1 of the first chemotherapy treatment to assess the effectiveness of the teaching session. In addition, questionnaire #3 will be administered at day 1 of cycle 2 of their first chemotherapy.

Detailed Description:

Chemotherapy teaching sessions, often coordinated in the outpatient setting by nursing personnel, are meant to educate patients about the chemotherapy they will be receiving. Education topics include an understanding of side effects, treatment schedule, medications to treat side effects and how to contact the oncology team if adverse events develop. Some of these issues are addressed in the American Society of Clinical Oncology's Quality Oncology Practice Initiative (QOPI). This study will perform an analysis of the teaching process that is provided prior to chemotherapy administration.

This study will provide data for each participating hospital to individually assess their teaching process. Multivariate analysis can be performed to evaluate whether age, sex, native, language, race highest level of education, cancer type, chemotherapy regimen, institution where chemotherapy will be administered, and type of personnel performing the teaching visit, influences the effectiveness of the teaching visit. In addition, results can be compared across different hospitals.This analysis may lead to improvements in each hospital's chemotherapy teaching practices and lead to advances in patient's cognitive and emotional preparedness.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cancer Clinics

Criteria

Inclusion Criteria:

  • Patients > 18 years of age who will be receiving chemotherapy (including targeted anticancer therapy) at a Brown University Oncology Research Group Affiliated Hospital for a period of 1-year after study activation.
  • Patients who will be undergoing a chemotherapy teaching session at an institution affiliated with the Brown University Oncology Research Group.
  • No prior chemotherapy or targeted anticancer treatment.
  • Signed informed consent

Exclusion Criteria:

Patients must meet eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01827761

Locations
United States, Rhode Island
Memorial Hospital
Pawtucket, Rhode Island, United States, 02860
Rhode Island Hospital (including Newport)
Providence, Rhode Island, United States, 02903
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Roger Williams Medical Center
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
Brown University
Rhode Island Hospital
The Miriam Hospital
Fatima Memorial Hospital
Roger Williams Medical Center
Lifespan
Investigators
Principal Investigator: Anthony Mega, MD Brown University
  More Information

No publications provided

Responsible Party: Dr Anthony Mega, Principal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT01827761     History of Changes
Other Study ID Numbers: 258
Study First Received: April 4, 2013
Last Updated: May 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brown University:
chemotherapy teaching
questionnaire

ClinicalTrials.gov processed this record on September 16, 2014