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.
|
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
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.