Decision Support Tools for Men With Prostate Cancer- Clinical & Lifestyle Model

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: Personalized risk model+website+coaching intervention

• Registration Number: NCT02451345
• Lead Sponsor: University of California, San Francisco

Brief Summary

A UCSF PI-initiated study with a primary goal to improve decision quality, anxiety, and uncertainty, thereby increasing appropriate uptake of active surveillance and reducing over-treatment of low-risk prostate cancer.

This study involves: completion of questionnaires through the secure website; consultation by a health coach to aid men with prostate cancer in making informed treatment decision (personalized coaching session(s)).

Detailed Description

A UCSF PI-initiated study which includes comprehensive decision support intervention that may incorporate clinical, lifestyle, tumor genomic, and germline gene variant data.

The web and coaching intervention will: 1) summarize key prognostic data elements, 2) communicate relative and absolute risks of upgrading/upstaging based on each of these elements, individually and in aggregate, and 3) provide tailored educational information for informed decision making on treatment options. A key aspect of the intervention will be provision of tiered coaching to the men prior to their physician visits to help them enter information accurately into the system, understand the results of the prediction model, document their questions for their physicians, and prepare them to make better-informed treatment decisions. UCSF research team will develop the decision support intervention in phases, initially using only clinical variables, BMI (body mass index), and smoking data;and then extend it to include information from genomic and genetic inputs, as validation work progresses. Variables will be retained based on statistical evaluation of the predictive values.

Study Timeline

• Study Start: 2015-03-25
• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-20
• Study First Posted: 2015-05-21
• Primary Completion: 2017-06-30
• Study Completion: 2020-04-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

1. men with missing data on PSA, stage, Gleason, or extent of biopsy core involvement; no baseline (diagnostic) biopsy or germline DNA sample for research; or no follow-up pathology (from biopsy or RP) after diagnosis.
2. men unable to consent, prisoners, those with ECOG performance status >2, or psychiatric illness/social situations that would limit compliance with study requirements, or inability to read English or Spanish.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Personalized risk model+website+coaching intervention	Personalized risk model+website+phone coaching

Primary Outcome Measures

Name	Time	Method
Decision Quality measured using the Decision Quality Index	12 months	measured using the Decision Quality Index

Secondary Outcome Measures

Name	Time	Method
Prostate Cancer Specific Anxiety measured using MAXPC survey	12 months	Measured using MAXPC survey
Decision Self- Efficacy measured using Decision Self-Efficacy survey	12 months	Measured using Decision Self-Efficacy survey

Trial Locations

Locations (2)

UCSF Helen Diller Family Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

University of California, San Francisco (SFGH); 🇺🇸 San Francisco, California, United States