Pioneering Advances in Care and Education (PACE)

NCT03397160 | Completed

• 3 other identifiers: 14-12951 / UCSF-HDFCC 17553A-17812.5a,b,c,d,fNCI-2018-01341
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (2)

• Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scores

  12 months

• Decision Self-Efficacy (DSE) Scores

  12 months

Study Arms (2)

Usual care

NO INTERVENTION

Participants assigned to the control arm will receive usual care, including whatever information materials are provided to them by their urologist.

Decision Support Intervention (DSI)

ACTIVE COMPARATOR

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.

Behavioral: Decision Support Intervention (DSI)

Interventions

Decision Support Intervention (DSI) BEHAVIORAL

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).

Also known as: PCa SCOPED model

Decision Support Intervention (DSI)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• CentraCare Adult & Pediatric Urology: collaborator
• Lancaster Urology: collaborator
• San Francisco Veterans Affairs Medical Center: collaborator
• Palo Alto Medical Foundation: collaborator

Study Sites (4)

Palo Alto Medical Foundation

Palo Alto, California, 94301, United States

Location

University of California San Francisco

San Francisco, California, 94158, United States

Location

CentraCare Clinic Adult & Pediatric Urology

Sartell, Minnesota, 56377, United States

Location

Lancaster Urology

Lancaster, Pennsylvania, 17604-3200, United States

Location

Related Publications (1)

• https://www.frontiersin.org/articles/10.3389/fruro.2023.1127089/full

  BACKGROUND

Related Links

• UCSF Department of Urology - Study Proposals and Working with Data

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Peter R Carroll, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: January 11, 2018
• Study Start: July 19, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

US (4)