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PACCT: Partnering Around Cancer Clinical Trials

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ClinicalTrials.gov Identifier: NCT02906241
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Susan Eggly, Barbara Ann Karmanos Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor Teams Behavioral: Physicians: Educational Module Not Applicable

Detailed Description:

This research utilizes two distinct research designs to evaluate two separate behavioral interventions.

The first is a between-subject randomized controlled trial to evaluate a patient-focused intervention. The intervention consists of a booklet designed to encourage patients to view themselves as part of the patient-physician team and to participate actively in clinical interactions by asking questions and stating concerns.

The second is a within-subject interrupted time series design to evaluate a physician-focused intervention. The intervention is an educational module and email reminders designed to encourage physicians to discuss trials with all eligible patients using patient-centered communication.In the patient-focused intervention, patients are randomized to an intervention or usual care group, and comparison of outcomes is made between groups.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 464 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: PACCT: Partnering Around Cancer Clinical Trials
Study Start Date : September 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients--Intervention
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
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.

No Intervention: Patients--Usual Care
Patients are randomized to the standard of care arm and participate in all aspects of the study but receive no intervention.
Physicians
Physicians receive the intervention approximately halfway through data collection for a within subjects, pre-post intervention comparison
Behavioral: Physicians: Educational Module
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




Primary Outcome Measures :
  1. Patient decisions to enroll in a trial [ Time Frame: 1 week following clinical interaction ]
    Single item: Did you agree to participate in this trial?


Secondary Outcome Measures :
  1. Physician offers of a clinical trial [ Time Frame: Day of clinical interaction; up to 2 years following enrollment ]
    Single item: Did the physician offer a trial?

  2. Patient Active Participation [ Time Frame: Day of clinical interaction; up to 2 years following enrollment ]
    Observers' global assessment of patients' participation in the interaction

  3. Quality of Informed Consent (modified) [ Time Frame: 1 week following clinical interaction ]
    12-item patient-self report on Quality of Informed Consent (QUIC)

  4. Patient enrollment in trial [ Time Frame: 3 months following clinical interaction ]
    medical chart abstraction

  5. Physician Patient-Centered Communication [ Time Frame: Day of clinical interaction; up to 2 years following enrollment ]
    Observers' rating of physician communication

  6. Quality of Trial-Related Communication [ Time Frame: Day of clinical interaction; up to 2 years following enrollment ]
    Observers' assessment of physician communication related to clinical trials

  7. Physician Patient-Centeredness [ Time Frame: Immediately following clinical interaction ]
    14-item patient self-report scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Physician participants

Inclusion criteria:

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

Exclusion criteria:

  • Do not treat patients with prostate cancer
  • Not able to recruit patients to clinical trials

Patient Participants

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906241


Contacts
Contact: Susan Eggly, Ph.D. (313) 576-8260 egglys@karmanos.org

Locations
United States, Maryland
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Michael Carducci, M.D.    410-955-8964      
Principal Investigator: Michael Carducci, M.D.         
Sub-Investigator: Dina Lansey, MSN         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Susan Eggly, Ph.D.    313-576-8260      
Principal Investigator: Susan Eggly, Ph.D.         
Sub-Investigator: Elisabeth I. Heath, M.D.         
Sub-Investigator: Louis A. Penner, Ph.D.         
Sub-Investigator: Terrance L. Albrecht, Ph.D.         
Sub-Investigator: Mark Manning, Ph.D.         
Sub-Investigator: Lauren Hamel, Ph.D.         
Sub-Investigator: Ellen Barton, Ph.D.         
Sub-Investigator: Seongho Kim, Ph.D         
Sponsors and Collaborators
Susan Eggly
National Cancer Institute (NCI)
Investigators
Principal Investigator: Susan Eggly, Ph.D. Wayne State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Susan Eggly, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT02906241     History of Changes
Other Study ID Numbers: 2016-098
R01CA200718-01 ( U.S. NIH Grant/Contract )
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by Susan Eggly, Barbara Ann Karmanos Cancer Institute:
African Americans
prostate cancer
Minority
Racial /Ethnic disparity
Cancer care
patient-physician communication
cancer clinical trial accrual

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases