NCT02451345

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)).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

2.3 years

First QC Date

May 19, 2015

Last Update Submit

July 21, 2020

Conditions

Prostate Cancer

Keywords

Prostate cancerTranformative Impact AwardEarly stageActive SurveillanceDecision aidCoaching sessionPersonalizedUCSFvalidation

Outcome Measures

Primary Outcomes (1)

  • Decision Quality measured using the Decision Quality Index

    measured using the Decision Quality Index

    12 months

Secondary Outcomes (2)

  • Prostate Cancer Specific Anxiety measured using MAXPC survey

    12 months

  • Decision Self- Efficacy measured using Decision Self-Efficacy survey

    12 months

Study Arms (1)

Intervention

EXPERIMENTAL

Personalized risk model+website+phone coaching

Behavioral: Personalized risk model+website+coaching intervention

Interventions

Personalized risk model+website+coaching interventionBEHAVIORAL

A health coach (members of the Patient Support Corps at the University of California San Francisco) will contact each subject individually to discuss his tailored/personalized web-portal report on his risk of aggressive disease and the pro/cons of treatment versus active surveillance. The contact between subject and the health coaches will be done before subject's visit with his primary urologist. Subjects will be asked to complete different questionnaires on four different occasions: one at first visit to the interactive secure web portal; one before coach's call; one after the coaching (after the urologist visit), and one at 6 months. The questionnaire after subject's visit with the urologist includes discussion about their management choice, decision quality, anxiety and satisfaction with care.

Intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men \>18 years of age with newly diagnosed (within 3 month) low risk prostatecancer , who have not yet received cancer-directed therapy, Or Men who are at risk of prostate cancer and coming to have a diagnostic biopsy, and diagnosed with low grade of prostate cancer
  • Biopsy Gleason score \< 3+3,
  • Has localized (clinical stage \< T2N0M0) prostate cancer with a PSA \<10ng/ml
  • Consent to research follow-up

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

University of California, San Francisco (SFGH)

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Peter Carroll, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 21, 2015

Study Start

March 25, 2015

Primary Completion

June 30, 2017

Study Completion

April 30, 2020

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)