Assessing The Impact Of Incorporating Charlson Comorbidity Scores On Patient Anxiety And Satisfaction
1 other identifier
interventional
277
0 countries
N/A
Brief Summary
The purpose of this study was to determine whether providing patients with life expectancy (LE) information in the form of their Prostate Cancer Comorbidity Index (PCCI) scores impacted their decisional conflict or anxiety about prostate cancer or death.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Jul 2013
Shorter than P25 for not_applicable prostate-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2015
CompletedFirst Submitted
Initial submission to the registry
May 9, 2019
CompletedFirst Posted
Study publicly available on registry
May 15, 2019
CompletedJune 12, 2019
June 1, 2019
1.6 years
May 9, 2019
June 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Traditional Decisional Conflict Scale (DCS)
This is to assess the ability to implement decisions. Each of the 16 questions range from strongly agree (a score of 1), to strongly disagree (a score of 5). The total score could be as low as 16 or as high as 80. A lower total score represents a better outcome, with a score of \<25 associated with the ability to implement decisions and a score of \>37.5 associated with decision delay and feeling unsure.
within 120 days of receiving counseling
Secondary Outcomes (1)
The Modified 18-item Memorial Anxiety Scale for Prostate Cancer
within 120 days of receiving counseling
Study Arms (2)
PCCI group
ACTIVE COMPARATORIn addition to standard of care counseling the additional provision of the patient's specific Prostate Cancer Comorbidity Index score and life expectancy estimation was provided.
Standard care
NO INTERVENTIONStandard of care was defined as prostate cancer counseling reflecting the best practices of a multidisciplinary team of urologists, radiation oncologists and medical oncologists.
Interventions
Eligibility Criteria
You may qualify if:
- Men 18 years and older
- Newly diagnosed prostate cancer
You may not qualify if:
- Non-English speaking
- Prior history of prostate cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benaroya Research Institutelead
- Virginia Mason Hospital/Medical Centercollaborator
- Axio Research Corporationcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John M Corman, MD
Benaroya Research Institute at Virginia Mason
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 9, 2019
First Posted
May 15, 2019
Study Start
July 12, 2013
Primary Completion
February 27, 2015
Study Completion
February 27, 2015
Last Updated
June 12, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share