Clinical trial NCT01827761: Assessment of the Effectiveness of Chemotherapy Teaching: BrUOG 258
Official title: Assessment of the Effectiveness of Chemotherapy Teaching: BrUOG 258
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: chemotherapy teaching
questionnaire
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Rhode Island Hospital
name: The Miriam Hospital
name: Fatima Memorial Hospital
name: Roger Williams Medical Center
name: Lifespan
First posted: 2013-04-10
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer Clinics

Brief 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.

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 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

Primary outcomes:
measure: Evaluate whether chemotherapy teaching sessions improves patient's knowledge, preparedness and anxiety in relation to chemotherapy
timeFrame: up to 1 month
Secondary outcomes:
measure: Compare changes in patient's knowledge, preparedness and anxiety in relation to chemotherapy teaching sessions
timeFrame: every 6 months up to two years
Other outcomes:
Locations:
city: Pawtucket
country: United States
facility: Memorial Hospital
state: Rhode Island
city: Providence
country: United States
facility: Rhode Island Hospital (including Newport)
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Providence
country: United States
facility: Roger Williams Medical Center
state: Rhode Island
Study officials:
affiliation: Brown University
name: Anthony Mega, MD
role: PRINCIPAL_INVESTIGATOR
References: