Prostate CancerNCT02906241
PACCT: Partnering Around Cancer Clinical Trials
A study testing Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor Teams and Physicians: Educational Module in people with Prostate Cancer, run by Susan Eggly at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor Teams and Physicians: Educational Module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Sep 2016to 17 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treat patients with prostate cancer
- Able to recruit patients to clinical trials
- 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
Who cannot join
- Do not treat patients with prostate cancer
- Not able to recruit patients to clinical trials
- Patient Participants
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer
Baltimore, Maryland, 21287
Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor Teams, Physicians: Educational Module
- Keywords
- African Americans, prostate cancer, Minority, Racial /Ethnic disparity, Cancer care, patient-physician communication, cancer clinical trial accrual
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor TeamsBehavioural
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 ModuleBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Patients--Intervention | Experimental | 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. Receives: Behavioral: Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor Teams |
| Patients--Usual Care | No intervention | Patients are randomized to the standard of care arm and participate in all aspects of the study but receive no intervention. |
| Physicians | Other | Physicians receive the intervention approximately halfway through data collection for a within subjects, pre-post intervention comparison Receives: Behavioral: Physicians: Educational Module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Offers of a Clinical Trial
Single item: Did the physician offer a trial?
Measured: Day of clinical interaction; up to 2 years following enrollment
Secondary outcomes (7)
Patient Decisions to Enroll in a Trial
Single item: Did you agree to participate in this trial?
Measured: 1 week following clinical interaction
Patient Active Participation
Observers' global assessment of patients' participation in the interaction
Measured: Day of clinical interaction; up to 2 years following enrollment
Quality of Informed Consent (Modified)
12-item patient-self report on Quality of Informed Consent (QUIC)
Measured: 1 week following clinical interaction
Patient Enrollment in Trial
medical chart abstraction
Measured: 3 months following clinical interaction
Physician Patient-Centered Communication
Observers' rating of physician communication
Measured: Day of clinical interaction; up to 2 years following enrollment
Quality of Trial-Related Communication
Observers' assessment of physician communication related to clinical trials
Measured: Day of clinical interaction; up to 2 years following enrollment
Physician Patient-Centeredness
14-item patient self-report scale
Measured: Immediately following clinical interaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start20 Sep 2016
- Primary completion17 Jul 2021
- Study completion17 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susan Eggly
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Susan Eggly, Barbara Ann Karmanos Cancer Institute
- Investigators
- Susan Eggly, Ph.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906241
- Sponsor's protocol ID
- 2016-098
- Other IDs
- R01CA200718-01
- Status last verified
- Dec 2022
- First submitted
- 8 Sep 2016
- Last updated
- 17 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Liyanage JSS, Ong V, Hamel LM, Eggly S, Carducci MA, Lansey DG, Heath EI, Moore TF, Albrecht TL, Manning MA, Kim S. Interconnectedness of Factors Affecting Patient Willingness to Discuss Prostate Cancer Clinical Trials With Physicians. JCO Oncol Pract. 2026 Aug 24:OP2600036. doi: 10.1200/OP-26-00036. Online ahead of print.
PubMed 42636423Eggly S, Manning M, Senft N, Moore TF, Albrecht TL, Penner LA, Heath E, Carducci MA, Lansey DG, Hamel LM. Development and pilot test of a physician-focused cancer clinical trials communication training intervention. PEC Innov. 2021 Dec 16;1:100012. doi: 10.1016/j.pecinn.2021.100012. eCollection 2022 Dec.
PubMed 37364021Eggly 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.
PubMed 29197371
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PACCT: Partnering Around Cancer Clinical Trials
- ClinicalTrials.gov ID
- NCT02906241
- Acronym / sponsor ID
- 2016-098
- Conditions
- Prostate Cancer
- Keywords
- African Americans, prostate cancer, Minority, Racial /Ethnic disparity, Cancer care, patient-physician communication, cancer clinical trial accrual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Susan EgglyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- 17 Jul 2021 (actual)
- Study completion
- 17 Jul 2021 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Posted 17 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients--Intervention | Experimental | Behavioral: Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor TeamsPatients 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--Usual Care | No intervention | –Patients are randomized to the standard of care arm and participate in all aspects of the study but receive no intervention. |
| Physicians | Other | Behavioral: Physicians: Educational ModulePhysicians receive the intervention approximately halfway through data collection for a within subjects, pre-post intervention comparison |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Treat patients with prostate cancer
- Able to recruit patients to clinical trials
- 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
Key exclusion criteria (7 listed)
- Do not treat patients with prostate cancer
- Not able to recruit patients to clinical trials
- Patient Participants
- Not black, African American or White; non Hispanic
- No confirmed diagnosis of prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor TeamsThis 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. | Behavioural | Patients--Intervention |
| Physicians: Educational ModulePhysicians 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 | Behavioural | Physicians |
Primary outcome
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?
7 secondary outcomes
Patient Decisions to Enroll in a Trial
Time frame: 1 week following clinical interaction
Patient Active Participation
Time frame: Day of clinical interaction; up to 2 years following enrollment
Quality of Informed Consent (Modified)
Time frame: 1 week following clinical interaction
Patient Enrollment in Trial
Time frame: 3 months following clinical interaction
Physician Patient-Centered Communication
Time frame: Day of clinical interaction; up to 2 years following enrollment
Quality of Trial-Related Communication
Time frame: Day of clinical interaction; up to 2 years following enrollment
Physician Patient-Centeredness
Time frame: Immediately following clinical interaction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42636423Liyanage JSS, Ong V, Hamel LM, Eggly S, Carducci MA, Lansey DG, Heath EI, Moore TF, Albrecht TL, Manning MA, Kim S. Interconnectedness of Factors Affecting Patient Willingness to Discuss Prostate Cancer Clinical Trials With Physicians. JCO Oncol Pract. 2026 Aug 24:OP2600036. doi: 10.1200/OP-26-00036. Online ahead of print.
- Derived from this study: PubMed 37364021Eggly S, Manning M, Senft N, Moore TF, Albrecht TL, Penner LA, Heath E, Carducci MA, Lansey DG, Hamel LM. Development and pilot test of a physician-focused cancer clinical trials communication training intervention. PEC Innov. 2021 Dec 16;1:100012. doi: 10.1016/j.pecinn.2021.100012. eCollection 2022 Dec.
- Derived from this study: PubMed 29197371Eggly 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Eggly, Ph.D. principal investigator
Wayne State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor Teams and Physicians: Educational Module in people with Prostate Cancer, run by Susan Eggly at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician Offers of a Clinical Trial (time frame: Day of clinical interaction; up to 2 years following enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02906241, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.