Clinical trial NCT03397160: Pioneering Advances in Care and Education (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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: CentraCare Adult & Pediatric Urology
name: Lancaster Urology
name: San Francisco Veterans Affairs Medical Center
name: Palo Alto Medical Foundation
First posted: 2018-01-11
Enrollment: 119
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: SUPPORTIVE_CARE

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.

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:

  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.

Primary outcomes:
measure: Decision Quality Index (DQI) scores
timeFrame: 12 months
Secondary outcomes:
measure: Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scores
timeFrame: 12 months
measure: Decision Self-Efficacy (DSE) Scores
timeFrame: 12 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Sartell
country: United States
facility: CentraCare Clinic Adult & Pediatric Urology
state: Minnesota
city: Lancaster
country: United States
facility: Lancaster Urology
state: Pennsylvania
Study officials:
affiliation: University of California, San Francisco
name: Peter R Carroll, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: https://www.frontiersin.org/articles/10.3389/fruro.2023.1127089/full