Trial Outcomes & Findings for PACCT: Partnering Around Cancer Clinical Trials (NCT NCT02906241)
NCT ID: NCT02906241
Last Updated: 2023-01-17
Results Overview
Single item: Did the physician offer a trial?
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
316 participants
Primary outcome timeframe
Day of clinical interaction; up to 2 years following enrollment
Results posted on
2023-01-17
Participant Flow
A total of 289 patients consented and completed baseline requirement. Of these, 54 qualified for randomization.
Participant milestones
| Measure |
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.
|
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
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
|
Patients Enrolled Not Randomized
Patients enrolled in the trial but did not qualify for randomization
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
29
|
27
|
235
|
|
Overall Study
COMPLETED
|
25
|
29
|
19
|
235
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
8
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PACCT: Partnering Around Cancer Clinical Trials
Baseline characteristics by cohort
| Measure |
Patients--Intervention
n=25 Participants
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.
|
Patients--Usual Care
n=29 Participants
Patients are randomized to the standard of care arm and participate in all aspects of the study but receive no intervention.
|
Physicians
n=27 Participants
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
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
Age, Continuous
Patients
|
66.2 years
STANDARD_DEVIATION 8.9 • n=99 Participants
|
66.52 years
STANDARD_DEVIATION 7.6 • n=107 Participants
|
0 years
STANDARD_DEVIATION 0 • n=206 Participants
|
66.36 years
STANDARD_DEVIATION 8.15 • n=7 Participants
|
|
Age, Continuous
Physicians
|
0 years
STANDARD_DEVIATION 0 • n=99 Participants
|
0 years
STANDARD_DEVIATION 0 • n=107 Participants
|
47.58 years
STANDARD_DEVIATION 11.61 • n=206 Participants
|
47.58 years
STANDARD_DEVIATION 11.61 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
77 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
29 participants
n=107 Participants
|
27 participants
n=206 Participants
|
81 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day of clinical interaction; up to 2 years following enrollmentPopulation: Data were collected only from participants in the Intervention Group in Phase 1 for this outcome measure
Single item: Did the physician offer a trial?
Outcome measures
| Measure |
Intervention and Offer
n=14 Participants
Patients who received the intervention and offer of a trial
|
|---|---|
|
Physician Offers of a Clinical Trial
|
14 Participants
|
SECONDARY outcome
Timeframe: 1 week following clinical interactionSingle item: Did you agree to participate in this trial?
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day of clinical interaction; up to 2 years following enrollmentObservers' global assessment of patients' participation in the interaction
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 week following clinical interaction12-item patient-self report on Quality of Informed Consent (QUIC)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months following clinical interactionmedical chart abstraction
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day of clinical interaction; up to 2 years following enrollmentObservers' rating of physician communication
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day of clinical interaction; up to 2 years following enrollmentObservers' assessment of physician communication related to clinical trials
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Immediately following clinical interaction14-item patient self-report scale
Outcome measures
Outcome data not reported
Adverse Events
Patients--Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients--Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Physicians
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Susan Eggly, PhD
Wayne State University/Karmanos Cancer Institute
Phone: 313-576-8260
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place