NCT02444754

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
267

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2019

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2021

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

3.7 years

First QC Date

May 12, 2015

Last Update Submit

September 7, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Attitudes towards and knowledge regarding clinical trials

    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.

    Baseline

  • Cancer-related health needs

    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.

    Baseline

  • Perceived quality of care

    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.

    Baseline

Secondary Outcomes (6)

  • Attitudes towards and knowledge regarding clinical trials

    Baseline

  • Attitudes towards and knowledge regarding clinical trials by the elderly

    Baseline

  • Cancer-related health needs by elderly patients

    Baseline

  • Cancer-related needs

    Baseline

  • Perceived quality of care

    Baseline

  • +1 more secondary outcomes

Study Arms (1)

Health services research (surveys, questionnaires)

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.

Other: Medical Chart ReviewOther: Questionnaire AdministrationOther: Survey Administration

Interventions

Obtain medical data

Also known as: Chart Review
Health services research (surveys, questionnaires)

Complete demographics questionnaires

Health services research (surveys, questionnaires)

Complete surveys

Health services research (surveys, questionnaires)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have received a diagnosis of a malignant cancer belonging to one of the minority/underserved populations.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Jimmy Ruiz

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 14, 2015

Study Start

January 1, 2016

Primary Completion

September 25, 2019

Study Completion

July 7, 2021

Last Updated

September 8, 2023

Record last verified: 2023-09

Locations