Clinical trial NCT02906241: PACCT: Partnering Around Cancer Clinical Trials
Official title: PACCT: Partnering Around Cancer Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: African Americans
prostate cancer
Minority
Racial /Ethnic disparity
Cancer care
patient-physician communication
cancer clinical trial accrual
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-09-20
Enrollment: 316
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Physician Offers of a Clinical Trial
timeFrame: Day of clinical interaction; up to 2 years following enrollment
Secondary outcomes:
measure: Patient Decisions to Enroll in a Trial
timeFrame: 1 week following clinical interaction
measure: Patient Active Participation
timeFrame: Day of clinical interaction; up to 2 years following enrollment
measure: Quality of Informed Consent (Modified)
timeFrame: 1 week following clinical interaction
measure: Patient Enrollment in Trial
timeFrame: 3 months following clinical interaction
measure: Physician Patient-Centered Communication
timeFrame: Day of clinical interaction; up to 2 years following enrollment
measure: Quality of Trial-Related Communication
timeFrame: Day of clinical interaction; up to 2 years following enrollment
measure: Physician Patient-Centeredness
timeFrame: Immediately following clinical interaction
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University/Sidney Kimmel Comprehensive Cancer
state: Maryland
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Wayne State University
name: Susan Eggly, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.