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Decision Support Systems, ClinicalPACENCT03397160

Pioneering Advances in Care and Education (PACE)

A study testing Decision Support Intervention (DSI) in people with Decision Support Systems, Clinical and Prostate Cancer, run by University of California, San Francisco at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Decision Support Intervention (DSI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
4 sitesUnited States
Study dates
19 Jul 2018to 30 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Lancaster Urology

    Lancaster, Pennsylvania, 17604-3200

  • Palo Alto Medical Foundation

    Palo Alto, California, 94301

  • University of California San Francisco

    San Francisco, California, 94158

  • CentraCare Clinic Adult & Pediatric Urology

    Sartell, Minnesota, 56377

Other trials in United States

About this study

Official title: Development, Validation, and Dissemination of an Integrated Risk Prediction Model and Decision Aid to Discern Aggressive Versus Indolent Prostate Cancer

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.

Read the 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.

Being tested
Decision Support Intervention (DSI)
Keywords
Prostate cancer, Transformative Impact Award, Early stage, Active surveillance, Decision aid, Coaching session, Personalized, University of California, San Francisco (UCSF), Validation
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Decision Support Intervention (DSI)Behavioural

    Also called PCa SCOPED model

    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).

Study groups in NCT03397160
Study groupRoleWhat they receive
Usual careNo interventionParticipants 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 comparatorParticipants 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.
Receives: Behavioral: Decision Support Intervention (DSI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (2)

  1. 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).

    Measured: 12 months

  2. 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).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2018
  2. Study start19 Jul 2018
  3. Primary completion30 Sep 2020
  4. Study completion30 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
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)
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03397160
Sponsor's protocol ID
14-12951 / UCSF-HDFCC 17553
Other IDs
A-17812.5a,b,c,d,f, NCI-2018-01341
Acronym
PACE
Status last verified
Jun 2023
First submitted
30 Nov 2017
Last updated
12 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available through a formal data request

Publications

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

Questions about this trial

What is this clinical trial studying?

A study testing Decision Support Intervention (DSI) in people with Decision Support Systems, Clinical and Prostate Cancer, run by University of California, San Francisco at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decision Quality Index (DQI) scores (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03397160, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.

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