PACCT: Partnering Around Cancer Clinical Trials
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02906241|
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : December 13, 2018
|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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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 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
- Patient decisions to enroll in a trial [ Time Frame: 1 week following clinical interaction ]Single item: Did you agree to participate in this trial?
- 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?
- Patient Active Participation [ Time Frame: Day of clinical interaction; up to 2 years following enrollment ]Observers' global assessment of patients' participation in the interaction
- Quality of Informed Consent (modified) [ Time Frame: 1 week following clinical interaction ]12-item patient-self report on Quality of Informed Consent (QUIC)
- Patient enrollment in trial [ Time Frame: 3 months following clinical interaction ]medical chart abstraction
- Physician Patient-Centered Communication [ Time Frame: Day of clinical interaction; up to 2 years following enrollment ]Observers' rating of physician communication
- 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
- Physician Patient-Centeredness [ Time Frame: Immediately following clinical interaction ]14-item patient self-report scale
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
|Contact: Susan Eggly, Ph.D.||(313) firstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins University/Sidney Kimmel Comprehensive Cancer||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|
|Principal Investigator:||Susan Eggly, Ph.D.||Wayne State University|