Assessing The Impact Of Incorporating Charlson Comorbidity Scores On Patient Anxiety And Satisfaction

June 10, 2019 updated by: John Corman, MD, Benaroya Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with newly diagnosed prostate cancer were consented and randomized to receive standard of care counseling (SOC) versus the same counseling plus provision of their specific LE (PCCI). Patients were blinded to the specific content of their counseling session. After counseling, patients completed the Decisional Conflict Scale (DCS), Death Anxiety Scale (DAS), Memorial Anxiety Scale for Prostate Cancer (MAX-PC), and Patient Satisfaction Questionnaire (PSQ-18). Treatment preferences were assessed.

Study Type

Interventional

Enrollment (Actual)

277

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men 18 years and older
  • Newly diagnosed prostate cancer

Exclusion Criteria:

  • Non-English speaking
  • Prior history of prostate cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PCCI group
In 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.
Other: Prostate Cancer Comorbidity Index (PCCI) score
Life expectancy information
No Intervention: Standard care
Standard of care was defined as prostate cancer counseling reflecting the best practices of a multidisciplinary team of urologists, radiation oncologists and medical oncologists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Traditional Decisional Conflict Scale (DCS)
Time Frame: within 120 days of receiving counseling
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Modified 18-item Memorial Anxiety Scale for Prostate Cancer
Time Frame: within 120 days of receiving counseling
This is to assess anxiety about prostate cancer. Each of the 18 questions range from not at all (a score of 1) to often (a score of 4). The total score could range from 18 to 72. A lower total score indicates less anxiety about prostate cancer and a lower score represents the better the outcome.
within 120 days of receiving counseling

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benaroya Research Institute

Collaborators

Virginia Mason Hospital/Medical Center
Axio Research Corporation

Investigators

  • Principal Investigator: John M Corman, MD, Benaroya Research Institute at Virginia Mason

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2013

Primary Completion (Actual)

February 27, 2015

Study Completion (Actual)

February 27, 2015

Study Registration Dates

First Submitted

May 9, 2019

First Submitted That Met QC Criteria

May 13, 2019

First Posted (Actual)

May 15, 2019

Study Record Updates

Last Update Posted (Actual)

June 12, 2019

Last Update Submitted That Met QC Criteria

June 10, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB13054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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