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

Patient Experience Protocol (PEP): A Pilot Study of Underserved Populations at the Comprehensive Cancer Center of Wake Forest University (CCCWFU)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02444754
Enrollment
267
Registered
2015-05-14
Start date
2016-01-31
Completion date
2021-07-07
Last updated
2023-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Neoplasm

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.

Interventions

OTHERMedical Chart Review

Obtain medical data

OTHERQuestionnaire Administration

Complete demographics questionnaires

OTHERSurvey Administration

Complete surveys

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frameDescription
Attitudes towards and knowledge regarding clinical trialsBaselineDescriptive 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.
Cancer-related health needsBaselineDescriptive 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.
Perceived quality of careBaselineDescriptive 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

MeasureTime frameDescription
Cancer-related needsBaselineAn 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 trialsBaselineAn 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 patientsBaselineDescriptive 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.
Perceived quality of careBaselineAn 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 by the elderlyBaselineDescriptive 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.
Cancer-related health needs by elderly patientsBaselineDescriptive 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026