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OpenTrials
Completed

NCT Number: NCT02906241

PACCT: Partnering Around Cancer Clinical Trials

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University/Sidney Kimmel Comprehensive Cancer, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

Behavioral

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.

Physicians: Educational Module

Behavioral

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 outcomes

  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?

Secondary outcomes

  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?

  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

Sponsors and collaborators

Lead sponsor

Susan Eggly

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Sep 20, 2016
Registry last updated
Jan 17, 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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