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Pioneering Advances in Care and Education (PACE) (PACE)

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ClinicalTrials.gov Identifier: NCT03397160
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : June 7, 2019
Sponsor:
Collaborators:
CentraCare Adult & Pediatric Urology
Lancaster Urology
San Francisco Veterans Affairs Medical Center
Palo Alto Medical Foundation
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Decision Support Systems, Clinical Prostate Cancer Behavioral: Decision Support Intervention (DSI) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Decision quality measured using the Decision Quality Index (DQI) [ Time Frame: 12 months ]
    Measured using the DQI survey


Secondary Outcome Measures :
  1. Prostate cancer specific anxiety measured using Memorial Anxiety Scale for Prostate Cancer (MaxPC) survey [ Time Frame: 12 months ]
    Measured using the MaxPC survey.

  2. Decision Self-Efficacy measured using Decision Self-Efficacy (DSE) survey [ Time Frame: 12 months ]
    Measured using the DSE survey



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male ≥18 years of age and newly diagnosed PCa (within 3-months).
  • Documentation of a low-risk PCa diagnosis as evidenced by clinical features of the following criteria:

    1. Prostate-specific antigen (PSA) test at diagnosis ≤15 ng/ml
    2. Localized prostate cancer (PCa) (clinical tumor staging 1/2,N0,M0)

    d. No treatment yet

  • English language proficient and ability to provide informed consent
  • Managing urologist considers them a candidate for active surveillance

Exclusion Criteria:

  • Participants will be ineligible if they: 1) have pursued any active therapy for prostate cancer will be excluded; 2) are unable to read/speak English; or 3) if their managing urologist does NOT deem them as a candidate for active surveillance.

Information from the National Library of Medicine

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


Contacts
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Contact: Jeffrey Belkora, PhD 415-964-0401 Jeff.Belkora@ucsf.edu
Contact: Jeanette M Broering, PhD, MPH 415-514-0203 Jenny.Broering@ucsf.edu

Locations
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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       delaraf1@sutterhealth.org   
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    pace@ucsf.edu   
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 Urology Recruiting
Lancaster, Pennsylvania, United States, 17604-3200
Contact: Christie Slaymacher    717-431-2285    christies@lancuro.com   
Contact: Jennifer Nonnemacher    717-431-2285    jennifern@lancuro.com   
Principal Investigator: Paul Sieber, MD         
Sponsors and Collaborators
University of California, San Francisco
CentraCare Adult & Pediatric Urology
Lancaster Urology
San Francisco Veterans Affairs Medical Center
Palo Alto Medical Foundation
Investigators
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Principal Investigator: Peter R Carroll, MD, MPH University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:

Additional Information:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03397160     History of Changes
Other Study ID Numbers: 14-12951 / UCSF-HDFCC 17553
A-17812.5a,b,c,d,f ( Other Identifier: HRPO-U.S. Army Medical Research and Materiel Command )
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available through a formal data request. For further guidance see: https://urology.ucsf.edu/research/cancer/study-proposals-and-working-with-data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:
Prostate cancer
Transformative Impact Award
Early stage
Active surveillance
Decision aid
Coaching session
Personalized
University of California, San Francisco (UCSF)
Validation

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases