Pioneering Advances in Care and Education (PACE)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Decision Support Systems, Clinical; Prostate Cancer

Treatments: Behavioral: Decision Support Intervention (DSI)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03397160

14-12951 / UCSF-HDFCC 17553

A-17812.5a,b,c,d,f (Other Identifier)

NCI-2018-01341 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

Usual care

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Decision Support Intervention (DSI)