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Completed

NCT Number: NCT01827761

Assessment of the Effectiveness of Chemotherapy Teaching: BrUOG 258

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Hospital, Pawtucket, Rhode Island, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Behavioral

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.

Primary outcomes

  1. Evaluate whether chemotherapy teaching sessions improves patient's knowledge, preparedness and anxiety in relation to chemotherapy

    Time frame: up to 1 month

    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 outcomes

  1. Compare changes in patient's knowledge, preparedness and anxiety in relation to chemotherapy teaching sessions

    Time frame: every 6 months up to two years

    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.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • Fatima Memorial Hospital
  • Lifespan
  • Rhode Island Hospital
  • Roger Williams Medical Center
  • The Miriam Hospital

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 10, 2013
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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