Back to resultsPACCT: Partnering Around Cancer Clinical Trials
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor Teams
Physicians: Educational Module
Sponsored by
About this trial
This is an interventional other trial for Prostate Cancer focused on measuring African Americans, prostate cancer, Minority, Racial /Ethnic disparity, Cancer care, patient-physician communication, cancer clinical trial accrual
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
Sites / Locations
- Johns Hopkins University/Sidney Kimmel Comprehensive Cancer
- Karmanos Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
Other
Arm Label
Patients--Intervention
Patients--Usual Care
Physicians
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Physician Offers of a Clinical Trial
Single item: Did the physician offer a trial?
Secondary Outcome Measures
Patient Decisions to Enroll in a Trial
Single item: Did you agree to participate in this trial?
Patient Active Participation
Observers' global assessment of patients' participation in the interaction
Quality of Informed Consent (Modified)
12-item patient-self report on Quality of Informed Consent (QUIC)
Patient Enrollment in Trial
medical chart abstraction
Physician Patient-Centered Communication
Observers' rating of physician communication
Quality of Trial-Related Communication
Observers' assessment of physician communication related to clinical trials
Physician Patient-Centeredness
14-item patient self-report scale
Full Information
NCT ID
NCT02906241
First Posted
September 8, 2016
Last Updated
December 20, 2022
Sponsor
Susan Eggly
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02906241
Brief Title
PACCT: Partnering Around Cancer Clinical Trials
Official Title
PACCT: Partnering Around Cancer Clinical Trials
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 20, 2016 (Actual)
Primary Completion Date
July 17, 2021 (Actual)
Study Completion Date
July 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Susan Eggly
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
African Americans, prostate cancer, Minority, Racial /Ethnic disparity, Cancer care, patient-physician communication, cancer clinical trial accrual
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
316 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients--Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients--Usual Care
Arm Type
No Intervention
Arm Description
Patients are randomized to the standard of care arm and participate in all aspects of the study but receive no intervention.
Arm Title
Physicians
Arm Type
Other
Arm Description
Physicians receive the intervention approximately halfway through data collection for a within subjects, pre-post intervention comparison
Intervention Type
Behavioral
Intervention Name(s)
Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor Teams
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physicians: Educational Module
Intervention Description
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 Measure Information:
Title
Physician Offers of a Clinical Trial
Description
Single item: Did the physician offer a trial?
Time Frame
Day of clinical interaction; up to 2 years following enrollment
Secondary Outcome Measure Information:
Title
Patient Decisions to Enroll in a Trial
Description
Single item: Did you agree to participate in this trial?
Time Frame
1 week following clinical interaction
Title
Patient Active Participation
Description
Observers' global assessment of patients' participation in the interaction
Time Frame
Day of clinical interaction; up to 2 years following enrollment
Title
Quality of Informed Consent (Modified)
Description
12-item patient-self report on Quality of Informed Consent (QUIC)
Time Frame
1 week following clinical interaction
Title
Patient Enrollment in Trial
Description
medical chart abstraction
Time Frame
3 months following clinical interaction
Title
Physician Patient-Centered Communication
Description
Observers' rating of physician communication
Time Frame
Day of clinical interaction; up to 2 years following enrollment
Title
Quality of Trial-Related Communication
Description
Observers' assessment of physician communication related to clinical trials
Time Frame
Day of clinical interaction; up to 2 years following enrollment
Title
Physician Patient-Centeredness
Description
14-item patient self-report scale
Time Frame
Immediately following clinical interaction
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Eggly, Ph.D.
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29197371
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.
Results Reference
derived
Learn more about this trial
PACCT: Partnering Around Cancer Clinical Trials
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