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Completed

NCT Number: NCT02444754

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

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.

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Key information

Conditions

Malignant Neoplasm Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

medical chart review

Other

Obtain medical data

Other names: Chart Review

Questionnaire Administration

Other

Complete demographics questionnaires

Survey Administration

Other

Complete surveys

Primary outcomes

  1. Attitudes towards and knowledge regarding clinical trials

    Time frame: 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.

  2. Cancer-related health needs

    Time frame: 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.

  3. Perceived quality of care

    Time frame: 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 outcomes

  1. Attitudes towards and knowledge regarding clinical trials

    Time frame: 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.

  2. Attitudes towards and knowledge regarding clinical trials by the elderly

    Time frame: 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.

  3. Cancer-related health needs by elderly patients

    Time frame: 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.

  4. Cancer-related needs

    Time frame: 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.

  5. Perceived quality of care

    Time frame: 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.

  6. Perceived quality of care received by elderly patients

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
May 14, 2015
Registry last updated
Sep 8, 2023

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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