Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01CA200718-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Offers of a Clinical Trial | Single item: Did the physician offer a trial? | Day of clinical interaction; up to 2 years following enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Decisions to Enroll in a Trial | Single item: Did you agree to participate in this trial? | 1 week following clinical interaction |
| Patient Active Participation | Observers' global assessment of patients' participation in the interaction |
Not provided
Physician participants
Inclusion criteria:
Exclusion criteria:
Patient Participants
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan Eggly, Ph.D. | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University/Sidney Kimmel Comprehensive Cancer | Baltimore | Maryland | 21287 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37364021 | Derived | Eggly 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. | |
| 29197371 | Derived | 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. |
Not provided
Not provided
A total of 289 patients consented and completed baseline requirement. Of these, 54 qualified for randomization.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Patients--Intervention | 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: 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. |
| FG001 | Patients--Usual Care | Patients are randomized to the standard of care arm and participate in all aspects of the study but receive no intervention. |
| FG002 | Physicians | Physicians receive the intervention approximately halfway through data collection for a within subjects, pre-post intervention comparison 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 |
| FG003 | Patients Enrolled Not Randomized | Patients enrolled in the trial but did not qualify for randomization |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Patients--Intervention | 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: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Physician Offers of a Clinical Trial | Single item: Did the physician offer a trial? | Data were collected only from participants in the Intervention Group in Phase 1 for this outcome measure | Posted | Count of Participants | Participants | Day of clinical interaction; up to 2 years following enrollment |
|
|
2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients--Intervention | 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: 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Eggly, PhD | Wayne State University/Karmanos Cancer Institute | 313-576-8260 | egglys@karmanos.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2018 | Jul 26, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
|
| 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) | 1 week following clinical interaction |
| Patient Enrollment in Trial | medical chart abstraction | 3 months following clinical interaction |
| Physician Patient-Centered Communication | Observers' rating of physician communication | Day of clinical interaction; up to 2 years following enrollment |
| Quality of Trial-Related Communication | Observers' assessment of physician communication related to clinical trials | Day of clinical interaction; up to 2 years following enrollment |
| Physician Patient-Centeredness | 14-item patient self-report scale | Immediately following clinical interaction |
| Karmanos Cancer Institute |
| Detroit |
| Michigan |
| 48201 |
| United States |
| BG001 | Patients--Usual Care | Patients are randomized to the standard of care arm and participate in all aspects of the study but receive no intervention. |
| BG002 | Physicians | Physicians receive the intervention approximately halfway through data collection for a within subjects, pre-post intervention comparison 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Patient Decisions to Enroll in a Trial | Single item: Did you agree to participate in this trial? | Not Posted | 1 week following clinical interaction | Participants |
| Secondary | Patient Active Participation | Observers' global assessment of patients' participation in the interaction | Not Posted | Day of clinical interaction; up to 2 years following enrollment | Participants |
| Secondary | Quality of Informed Consent (Modified) | 12-item patient-self report on Quality of Informed Consent (QUIC) | Not Posted | 1 week following clinical interaction | Participants |
| Secondary | Patient Enrollment in Trial | medical chart abstraction | Not Posted | 3 months following clinical interaction | Participants |
| Secondary | Physician Patient-Centered Communication | Observers' rating of physician communication | Not Posted | Day of clinical interaction; up to 2 years following enrollment | Participants |
| Secondary | Quality of Trial-Related Communication | Observers' assessment of physician communication related to clinical trials | Not Posted | Day of clinical interaction; up to 2 years following enrollment | Participants |
| Secondary | Physician Patient-Centeredness | 14-item patient self-report scale | Not Posted | Immediately following clinical interaction | Participants |
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Patients--Usual Care | Patients are randomized to the standard of care arm and participate in all aspects of the study but receive no intervention. | 0 | 29 | 0 | 29 | 0 | 29 |
| EG002 | Physicians | Physicians receive the intervention approximately halfway through data collection for a within subjects, pre-post intervention comparison 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 | 0 | 27 | 0 | 27 | 0 | 27 |
Not provided
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |