Assessment of the Effectiveness of Chemotherapy Teaching: BrUOG 258

Cancer Clinical Trial

Official title:

Assessment of the Effectiveness of Chemotherapy Teaching: BrUOG 258

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827761
• Other study ID #: 258
• Status: Completed
• Start date: October 2011
• Est. completion date: May 2014

Study information

• Verified date: February 2022
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Hospital	Pawtucket	Rhode Island
United States	Rhode Island Hospital (including Newport)	Providence	Rhode Island
United States	Roger Williams Medical Center	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (6)

Lead Sponsor	Collaborator
Brown University	Fatima Memorial Hospital, Lifespan, Rhode Island Hospital, Roger Williams Medical Center, The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate whether chemotherapy teaching sessions improves patient's knowledge, preparedness and anxiety in relation to chemotherapy	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.	up to 1 month
Secondary	Compare changes in patient's knowledge, preparedness and anxiety in relation to chemotherapy teaching sessions	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.	every 6 months up to two years