Pioneering Advances in Care and Education (PACE) (PACE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03397160|
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : June 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Decision Support Systems, Clinical Prostate Cancer||Behavioral: Decision Support Intervention (DSI)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Crossover Assignment|
|Intervention 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)|
|Primary Purpose:||Supportive Care|
|Official Title:||Development, Validation, and Dissemination of an Integrated Risk Prediction Model and Decision Aid to Discern Aggressive Versus Indolent Prostate Cancer|
|Actual Study Start Date :||October 10, 2017|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||September 30, 2019|
No Intervention: Usual care
Participants assigned to the control arm will receive usual care, including whatever information materials are provided to them by their urologist.
Active Comparator: Decision Support Intervention (DSI)
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 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.
Behavioral: Decision Support Intervention (DSI)
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).
Other Name: PCa SCOPED model
- Decision quality measured using the Decision Quality Index (DQI) [ Time Frame: 12 months ]Measured using the DQI survey
- Prostate cancer specific anxiety measured using Memorial Anxiety Scale for Prostate Cancer (MaxPC) survey [ Time Frame: 12 months ]Measured using the MaxPC survey.
- Decision Self-Efficacy measured using Decision Self-Efficacy (DSE) survey [ Time Frame: 12 months ]Measured using the DSE survey
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397160
|Contact: Jeffrey Belkora, PhD||415-964-0401||Jeff.Belkora@ucsf.edu|
|Contact: Jeanette M Broering, PhD, MPH||415-514-0203||Jenny.Broering@ucsf.edu|
|United States, California|
|Palo Alto Medical Foundation||Recruiting|
|Palo Alto, California, United States, 94301|
|Contact: Quan Truong, MPH 650-330-4528 TruongQ1@pamf.org|
|Contact: Frank Delarama, RN, MS email@example.com|
|Principal Investigator: Daniel Yao, MD|
|San Francisco VA Medical Center||Recruiting|
|San Francisco, California, United States, 94121|
|Contact: Ada F Sanchez, BA 800-526-4433 firstname.lastname@example.org|
|Principal Investigator: Matthew R Cooperberg, MD, MPH|
|University of California San Francisco||Recruiting|
|San Francisco, California, United States, 94158|
|Contact: Imelda Tenggara 415-353-7348 Imelda.Tenggara@ucsf.edu|
|Contact: Karen Stevenson 415-514-9398 Karen.Stevenson@ucsf.edu|
|Principal Investigator: Peter R Carroll, MD, MPH|
|United States, Minnesota|
|CentraCare Clinic Adult & Pediatric Urology||Recruiting|
|Sartell, Minnesota, United States, 56377|
|Contact: Dawn Bauerly-Pieper, BSN 320-229-4547 Dawn.Bauerly-Pieper@centracare.com|
|Principal Investigator: Lori A Pinke, MD|
|United States, Pennsylvania|
|Lancaster, Pennsylvania, United States, 17604-3200|
|Contact: Christie Slaymacher 717-431-2285 email@example.com|
|Contact: Jennifer Nonnemacher 717-431-2285 firstname.lastname@example.org|
|Principal Investigator: Paul Sieber, MD|
|Principal Investigator:||Peter R Carroll, MD, MPH||University of California, San Francisco|