Back to resultsPioneering Advances in Care and Education (PACE) (PACE)
Primary Purpose
Decision Support Systems, Clinical, Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Support Intervention (DSI)
Sponsored by
About this trial
This is an interventional supportive care trial for Decision Support Systems, Clinical focused on measuring Prostate cancer, Transformative Impact Award, Early stage, Active surveillance, Decision aid, Coaching session, Personalized, University of California, San Francisco (UCSF), Validation
Eligibility Criteria
Inclusion Criteria:
- Male >=18 years of age and newly diagnosed prostate cancer (PCa) (within 3-months).
Documentation of a low-risk PCa diagnosis as evidenced by clinical features of the following criteria:
- PSA test at diagnosis <=15 ng/ml
- Localized PCa (cT1/T2,N0,M0)
Biopsy Gleason grade 2-6 OR (or 3+4 AND <=33% cores are positive for adenocarcinoma)
***A minimum of 10 diagnostic cores taken by a systematic directed approach. Sampling may be obtained by target transrectal ultrasound (TRUS) or MRI imaging.
No treatment yet
- No previous radiation or simultaneous use of androgen deprivation
- Prior use of 5-alpha reductase inhibitor is allowed if they have been stopped for 6 or more months and biopsy performed when patient was not taking the drug
- English language proficient and ability to provide informed consent
- Managing urologist considers them a candidate for active surveillance
- Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study, including the ability to read and speak English.
Exclusion Criteria:
Participants will be ineligible if they:
- have pursued any active therapy for prostate cancer will be excluded;
- are unable to read/speak English; or
- if their managing urologist does NOT deem them as a candidate for active surveillance.
Sites / Locations
- Palo Alto Medical Foundation
- University of California San Francisco
- CentraCare Clinic Adult & Pediatric Urology
- Lancaster Urology
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Usual care
Decision Support Intervention (DSI)
Arm Description
Participants assigned to the control arm will receive usual care, including whatever information materials are provided to them by their urologist.
Participants assigned to the intervention will receive Decision Support Intervention in the form of a decision aid plus health coaching. The decision aid (delivered by internet and as a Portable Document Format (PDF) document) provides participants with a report on options and outcomes as described in the literature; along with more tailored risk information. The tailored risk information will include their estimated risk of harboring more aggressive prostate cancer based on their clinical/pathologic features (i.e., "My Clinical Risk"). The DSI was developed and piloted at UCSF according to the International Patient Decision Aid Standards (see http://ipdas.ohri.ca/) (IRS# 14-13332), and incorporates tailored risk models developed and validated.
Outcomes
Primary Outcome Measures
Decision Quality Index (DQI) scores
The DQI measures patient Knowledge, Concordance, and Decision process. For each fact about prostate cancer item, a correct response = 1 point. Missing responses=0 points. Total score is calculated for all patients who complete at least half of the items and scaled from 0-100%, with higher scores indicating greater knowledge. Patients rate their goals and concerns on an 11-point importance scale from 0 (not important at all) to 10 (extremely important). These questions + one question about patient's treatment preference can be used to calculate a concordance score. Patients are asked about whether they were offered a choice, how much pros and cons were discussed, and whether the health care provider asked for their preferences. Participants get 1 point for a response of "yes" / "a lot/some.", total points are summed, then divided by total number of items for a decision making process score from 0-100%. Higher scores indicate a more shared decision making process.
Secondary Outcome Measures
Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scores
The MAX-PC is an 18-item questionnaire with a 4-point Likert-type scale asking how frequently certain "comments made by men about prostate cancer" were true of the respondent (Roth et al., 2003). Each item is scored from 0 to 4 with anchors ranging from "Not at all" to "Often." The scale can be scored in its entirety by summing all the items or summary scores can be grouped into Prostate Cancer Anxiety (11 items), Prostate-specific antigen (PSA) Anxiety (3 items), or Fear of Re-occurrence (4 items).
Decision Self-Efficacy (DSE) Scores
The DSE measures self-confidence or belief in one's ability to make informed decisions and participate in shared decision making with health professionals. It is a 11-item instrument with a five-point response scale ranging from 0 (not at all confident) to 4 (very confident).
Full Information
NCT ID
NCT03397160
First Posted
November 30, 2017
Last Updated
June 8, 2023
Sponsor
University of California, San Francisco
Collaborators
CentraCare Adult & Pediatric Urology, Lancaster Urology, San Francisco Veterans Affairs Medical Center, Palo Alto Medical Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03397160
Brief Title
Pioneering Advances in Care and Education (PACE)
Acronym
PACE
Official Title
Development, Validation, and Dissemination of an Integrated Risk Prediction Model and Decision Aid to Discern Aggressive Versus Indolent Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 19, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
CentraCare Adult & Pediatric Urology, Lancaster Urology, San Francisco Veterans Affairs Medical Center, Palo Alto Medical Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This clinical trial evaluates the use of novel decision support educational materials and services using health coaches. The study includes men newly diagnosed with low-risk prostate cancer. A 160 men will be recruited. Half of the men will receive a call from a health coach before their initial consultation visit with their urologist to review their treatment concerns and questions. The other half will receive usual care provided by the urologist, such as educational materials and services provided by the urologist.
Detailed Description
A critical public health need exists for improved prognostic tools to distinguish aggressive from slow growing prostate cancer at diagnosis, and for better support systems to guide patients in decision-making regarding management options.
Decision support interventions that are tailored to specific clinical conditions are known to have increased patient self-efficacy, knowledge, question-asking, and satisfaction; and decreased decisional conflict, regret, anxiety, and distress.
To reduce the risk of over-treatment, our team has developed individual risk prediction models that we have now integrated into our decision support intervention (DSI).
Delivering such decision support intervention should increase patient knowledge and question-asking by the patient to their doctor.
The decision support intervention can be delivered by telephone and or the Internet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decision Support Systems, Clinical, Prostate Cancer
Keywords
Prostate cancer, Transformative Impact Award, Early stage, Active surveillance, Decision aid, Coaching session, Personalized, University of California, San Francisco (UCSF), Validation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is a site-randomized, cluster-crossover clinical trial of a decision support intervention (DSI) vs. usual care, among men with low prognostic risk prostate cancer, to assess differences in informed decision making (i.e., knowledge), anxiety, and decision quality and self-efficacy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants assigned to the control arm will receive usual care, including whatever information materials are provided to them by their urologist.
Arm Title
Decision Support Intervention (DSI)
Arm Type
Active Comparator
Arm Description
Participants assigned to the intervention will receive Decision Support Intervention in the form of a decision aid plus health coaching. The decision aid (delivered by internet and as a Portable Document Format (PDF) document) provides participants with a report on options and outcomes as described in the literature; along with more tailored risk information. The tailored risk information will include their estimated risk of harboring more aggressive prostate cancer based on their clinical/pathologic features (i.e., "My Clinical Risk"). The DSI was developed and piloted at UCSF according to the International Patient Decision Aid Standards (see http://ipdas.ohri.ca/) (IRS# 14-13332), and incorporates tailored risk models developed and validated.
Intervention Type
Behavioral
Intervention Name(s)
Decision Support Intervention (DSI)
Other Intervention Name(s)
PCa SCOPED model
Intervention Description
A question list (QL) that includes areas of patient concern are created by the health coach for use by the patient and the urologist at their first consultation visit where they discuss the extent of their cancer and consider treatment options. The coach uses the Prostate Cancer SCOPED model to complete a "Prostate Cancer SCOPED Model Form". The SCOPED model uses concepts such as the situation, choices (treatment), objectives (personal goals and priorities), people (involved in supporting a treatment decision), evaluation and decisions (clarifying which choice is best and next steps).
Primary Outcome Measure Information:
Title
Decision Quality Index (DQI) scores
Description
The DQI measures patient Knowledge, Concordance, and Decision process. For each fact about prostate cancer item, a correct response = 1 point. Missing responses=0 points. Total score is calculated for all patients who complete at least half of the items and scaled from 0-100%, with higher scores indicating greater knowledge. Patients rate their goals and concerns on an 11-point importance scale from 0 (not important at all) to 10 (extremely important). These questions + one question about patient's treatment preference can be used to calculate a concordance score. Patients are asked about whether they were offered a choice, how much pros and cons were discussed, and whether the health care provider asked for their preferences. Participants get 1 point for a response of "yes" / "a lot/some.", total points are summed, then divided by total number of items for a decision making process score from 0-100%. Higher scores indicate a more shared decision making process.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scores
Description
The MAX-PC is an 18-item questionnaire with a 4-point Likert-type scale asking how frequently certain "comments made by men about prostate cancer" were true of the respondent (Roth et al., 2003). Each item is scored from 0 to 4 with anchors ranging from "Not at all" to "Often." The scale can be scored in its entirety by summing all the items or summary scores can be grouped into Prostate Cancer Anxiety (11 items), Prostate-specific antigen (PSA) Anxiety (3 items), or Fear of Re-occurrence (4 items).
Time Frame
12 months
Title
Decision Self-Efficacy (DSE) Scores
Description
The DSE measures self-confidence or belief in one's ability to make informed decisions and participate in shared decision making with health professionals. It is a 11-item instrument with a five-point response scale ranging from 0 (not at all confident) to 4 (very confident).
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male >=18 years of age and newly diagnosed prostate cancer (PCa) (within 3-months).
Documentation of a low-risk PCa diagnosis as evidenced by clinical features of the following criteria:
PSA test at diagnosis <=15 ng/ml
Localized PCa (cT1/T2,N0,M0)
Biopsy Gleason grade 2-6 OR (or 3+4 AND <=33% cores are positive for adenocarcinoma)
***A minimum of 10 diagnostic cores taken by a systematic directed approach. Sampling may be obtained by target transrectal ultrasound (TRUS) or MRI imaging.
No treatment yet
No previous radiation or simultaneous use of androgen deprivation
Prior use of 5-alpha reductase inhibitor is allowed if they have been stopped for 6 or more months and biopsy performed when patient was not taking the drug
English language proficient and ability to provide informed consent
Managing urologist considers them a candidate for active surveillance
Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study, including the ability to read and speak English.
Exclusion Criteria:
Participants will be ineligible if they:
have pursued any active therapy for prostate cancer will be excluded;
are unable to read/speak English; or
if their managing urologist does NOT deem them as a candidate for active surveillance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter R Carroll, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palo Alto Medical Foundation
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
CentraCare Clinic Adult & Pediatric Urology
City
Sartell
State/Province
Minnesota
ZIP/Postal Code
56377
Country
United States
Facility Name
Lancaster Urology
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604-3200
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available through a formal data request
IPD Sharing URL
https://urology.ucsf.edu/research/cancer/study-proposals-and-working-with-data
Citations:
Citation
https://www.frontiersin.org/articles/10.3389/fruro.2023.1127089/full
Results Reference
background
Links:
URL
https://urology.ucsf.edu/research/cancer/study-proposals-and-working-with-data
Description
UCSF Department of Urology - Study Proposals and Working with Data
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Pioneering Advances in Care and Education (PACE)
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