Attitudes and Knowledge Regarding Clinical Trials in Underserved Populations Receiving Care at the Comprehensive Cancer Center of Wake Forest University

Completed

• Conditions: Malignant Neoplasm
• Interventions: Other: Medical Chart Review; Other: Questionnaire Administration; Other: Survey Administration

• Registration Number: NCT02444754
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

This pilot research trial studies minority patients receiving care at the Comprehensive Cancer Center of Wake Forest University (CCCWFU) to see what their attitudes are regarding the healthcare they receive and how much they know about clinical trials. Clinical trials are an important way to test healthcare treatments and need diverse participants to be most effective. Studying what minority patients think about healthcare and clinical trials may help researchers learn more about why minorities are less likely to enroll in clinical trials and create programs to help increase their enrollment.

Detailed Description

PRIMARY OBJECTIVES:

I. To describe perceived quality of care received in the CCCWFU adult oncology clinics by patients belonging to one of the racial/ethnic minority and underserved populations (Hispanic/Latino, Black/African American, rural, uninsured, or young adult).

II. To describe cancer-related health needs of racial/ethnic minority and underserved patients in the CCCWFU adult oncology clinics.

III. To describe attitudes towards, and knowledge regarding, clinical trials in racial/ethnic minority and underserved patients treated in the CCCWFU adult oncology clinics.

SECONDARY OBJECTIVES:

I. To compare levels of perceived quality of care, cancer-related health needs and attitudes towards and knowledge of clinical trials in racial/ethnic minority and underserved patients to a comparison group of non-minority/underserved patients treated in the CCCWFU adult oncology clinics.

II. To describe perceived quality of care received in the CCCWFU adult oncology clinics, cancer-related health needs, and attitudes towards, and knowledge regarding clinical trials by elderly patients.

OUTLINE:

Patients complete survey items across a number of domains (patient characteristics, access to health care, perceived quality of care, clinical trial knowledge and attitudes, and cancer related health needs). Patients also complete questionnaires to obtain demographics information including age, education, race and ethnicity, marital status, employment status, insurance coverage, and income, as well as health status/indicators. Cancer-related characteristics, including diagnosis, stage, time since diagnosis, and treatments received are obtained self-report and patients' medical records.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-05-12
• Study First Posted: 2015-05-14
• Study Start: 2016-01
• Primary Completion: 2019-09-25
• Study Completion: 2021-07-07
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

Inclusion Criteria

• Patients who have received a diagnosis of a malignant cancer
• Patients belonging to one of the minority/underserved populations: self-reported Hispanic/Latino or Black/African American, rural, uninsured, or young adult (ages 18-39) at the time of diagnosis, or are a randomly sampled patient with an upcoming scheduled appointment at CCCWFU that does not meet the definition of underserved for this study
• Patients who have a scheduled outpatient appointment physically located at a CCCWFU adult oncology clinic (main medical campus) and have completed at least three outpatient medical appointments at CCCWFU in the adult oncology clinics

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Exclusion Criteria

• Patients who receive their cancer care in clinics outside of adult oncology at CCCWFU
• Patients receiving care at the CCCWFU adult oncology clinics for screening, diagnostic or non-cancer related reasons only
• Unable or unwilling to consent or complete the survey

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Health services research (surveys, questionnaires)	Survey Administration	Patients complete survey items across a number of domains (patient characteristics, access to health care, perceived quality of care, clinical trial knowledge and attitudes, and cancer related health needs). Patients also complete questionnaires to obtain demographics information including age, education, race and ethnicity, marital status, employment status, insurance coverage, and income, as well as health status/indicators. Cancer-related characteristics, including diagnosis, stage, time since diagnosis, and treatments received are obtained self-report and patients' medical records.
Health services research (surveys, questionnaires)	Medical Chart Review	Patients complete survey items across a number of domains (patient characteristics, access to health care, perceived quality of care, clinical trial knowledge and attitudes, and cancer related health needs). Patients also complete questionnaires to obtain demographics information including age, education, race and ethnicity, marital status, employment status, insurance coverage, and income, as well as health status/indicators. Cancer-related characteristics, including diagnosis, stage, time since diagnosis, and treatments received are obtained self-report and patients' medical records.
Health services research (surveys, questionnaires)	Questionnaire Administration	Patients complete survey items across a number of domains (patient characteristics, access to health care, perceived quality of care, clinical trial knowledge and attitudes, and cancer related health needs). Patients also complete questionnaires to obtain demographics information including age, education, race and ethnicity, marital status, employment status, insurance coverage, and income, as well as health status/indicators. Cancer-related characteristics, including diagnosis, stage, time since diagnosis, and treatments received are obtained self-report and patients' medical records.

Primary Outcome Measures

Name	Time	Method
Cancer-related health needs	Baseline	Descriptive statistics will be used to summarize cancer-related health needs for each underserved group means and standard deviations for continuous variables and frequencies for categorical variables.
Attitudes towards and knowledge regarding clinical trials	Baseline	Descriptive statistics will be used to summarize patient attitudes towards and knowledge of clinical trials for each underserved group and for the elderly using means and standard deviations for continuous variables and frequencies for categorical variables.
Perceived quality of care	Baseline	Descriptive statistics will be used to summarize perceived quality of care for each underserved group using means and standard deviations for continuous variables and frequencies for categorical variables.

Secondary Outcome Measures

Name	Time	Method
Attitudes towards and knowledge regarding clinical trials by the elderly	Baseline	Descriptive statistics will be used to summarize attitudes towards and knowledge regarding clinical trials for the elderly using means and standard deviations for continuous variables and frequencies for categorical variables.
Perceived quality of care	Baseline	An analysis of variance (ANOVA) model will be used for continuous outcomes and a logistic model will be used for dichotomous outcomes with group (each underserved population or the comparison group) as the primary predictor to evaluate if the outcomes differ by group, utilizing contrasts to compare the underserved groups to each other, and the underserved groups as a whole to the comparison group. An overall alpha level of 0.05 will be used to indicate statistical significance for the comparison of the underserved group to the comparison group.
Attitudes towards and knowledge regarding clinical trials	Baseline	An ANOVA model will be used for continuous outcomes and a logistic model will be used for dichotomous outcomes with group (each underserved population or the comparison group) as the primary predictor to evaluate if the outcomes differ by group, utilizing contrasts to compare the underserved groups to each other, and the underserved groups as a whole to the comparison group. An overall alpha level of 0.05 will be used to indicate statistical significance for the comparison of the underserved group to the comparison group.
Cancer-related health needs by elderly patients	Baseline	Descriptive statistics will be used to summarize cancer-related health needs for the elderly using means and standard deviations for continuous variables and frequencies for categorical variables.
Cancer-related needs	Baseline	An ANOVA model will be used for continuous outcomes and a logistic model will be used for dichotomous outcomes with group (each underserved population or the comparison group) as the primary predictor to evaluate if the outcomes differ by group, utilizing contrasts to compare the underserved groups to each other, and the underserved groups as a whole to the comparison group. An overall alpha level of 0.05 will be used to indicate statistical significance for the comparison of the underserved group to the comparison group.
Perceived quality of care received by elderly patients	Baseline	Descriptive statistics will be used to summarize perceived quality of care for the elderly using means and standard deviations for continuous variables and frequencies for categorical variables.

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States