NCT02906241

Brief Summary

This research has the overall goal of increasing rates at which African American and White men with prostate cancer make an informed decision to participate in a cancer clinical trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
316

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

2 active sites

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

September 8, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

September 20, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2021

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 17, 2023

Completed
Last Updated

January 17, 2023

Status Verified

December 1, 2022

Enrollment Period

4.8 years

First QC Date

September 8, 2016

Results QC Date

August 22, 2022

Last Update Submit

December 20, 2022

Conditions

Keywords

African Americansprostate cancerMinorityRacial /Ethnic disparityCancer carepatient-physician communicationcancer clinical trial accrual

Outcome Measures

Primary Outcomes (1)

  • Physician Offers of a Clinical Trial

    Single item: Did the physician offer a trial?

    Day of clinical interaction; up to 2 years following enrollment

Secondary Outcomes (7)

  • Patient Decisions to Enroll in a Trial

    1 week following clinical interaction

  • Patient Active Participation

    Day of clinical interaction; up to 2 years following enrollment

  • Quality of Informed Consent (Modified)

    1 week following clinical interaction

  • Patient Enrollment in Trial

    3 months following clinical interaction

  • Physician Patient-Centered Communication

    Day of clinical interaction; up to 2 years following enrollment

  • +2 more secondary outcomes

Study Arms (3)

Patients--Intervention

EXPERIMENTAL

Patients are randomized to an intervention group. They participate in all aspects of the study and also receive the intervention, which consists of a booklet.

Behavioral: Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor Teams

Patients--Usual Care

NO INTERVENTION

Patients are randomized to the standard of care arm and participate in all aspects of the study but receive no intervention.

Physicians

OTHER

Physicians receive the intervention approximately halfway through data collection for a within subjects, pre-post intervention comparison

Behavioral: Physicians: Educational Module

Interventions

This booklet encourages patients to view themselves as members of the patient-doctor team and to participate actively during clinical interactions by asking questions and stating concerns.

Patients--Intervention

Physicians will participate in an educational module and receive email prompts to encourage them to discuss trials with all patients who are eligible for a clinical trial, using patient-centered communication

Physicians

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Treat patients with prostate cancer
  • Able to recruit patients to clinical trials

You may not qualify if:

  • Do not treat patients with prostate cancer
  • Not able to recruit patients to clinical trials
  • Patient Participants
  • Black, African American or White; Non-hispanic confirmed diagnosis of prostate Cancer
  • Seeing a participating physician for less than a year and expect to see this physician at least once in the coming year
  • Able to read and write English well enough to understand and sign consent forms and respond to questionnaires
  • Not black, African American or White; non Hispanic
  • No confirmed diagnosis of prostate cancer
  • Not seeing a participating physician or seeing a participating physician for \> than one year
  • Not able to read and write English well enough to understand and sign consent forms and respond to questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins University/Sidney Kimmel Comprehensive Cancer

Baltimore, Maryland, 21287, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Related Publications (2)

  • Eggly S, Manning M, Senft N, Moore TF, Albrecht TL, Penner LA, Heath E, Carducci MA, Lansey DG, Hamel LM. Development and pilot test of a physician-focused cancer clinical trials communication training intervention. PEC Innov. 2021 Dec 16;1:100012. doi: 10.1016/j.pecinn.2021.100012. eCollection 2022 Dec.

  • Eggly S, Hamel LM, Heath E, Manning MA, Albrecht TL, Barton E, Wojda M, Foster T, Carducci M, Lansey D, Wang T, Abdallah R, Abrahamian N, Kim S, Senft N, Penner LA. Partnering around cancer clinical trials (PACCT): study protocol for a randomized trial of a patient and physician communication intervention to increase minority accrual to prostate cancer clinical trials. BMC Cancer. 2017 Dec 2;17(1):807. doi: 10.1186/s12885-017-3804-5.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Susan Eggly, PhD
Organization
Wayne State University/Karmanos Cancer Institute

Study Officials

  • Susan Eggly, Ph.D.

    Wayne State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 20, 2016

Study Start

September 20, 2016

Primary Completion

July 17, 2021

Study Completion

July 17, 2021

Last Updated

January 17, 2023

Results First Posted

January 17, 2023

Record last verified: 2022-12

Locations