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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03950180
Enrollment
277
Registered
2019-05-15
Start date
2013-07-12
Completion date
2015-02-27
Last updated
2019-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

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.

Interventions

OTHERProstate Cancer Comorbidity Index (PCCI) score

Life expectancy information

Sponsors

Virginia Mason Hospital/Medical Center
CollaboratorOTHER
Axio Research Corporation
CollaboratorINDUSTRY
Benaroya Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Men 18 years and older * Newly diagnosed prostate cancer

Exclusion criteria

* Non-English speaking * Prior history of prostate cancer

Design outcomes

Primary

MeasureTime frameDescription
Traditional Decisional Conflict Scale (DCS)within 120 days of receiving counselingThis 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.

Secondary

MeasureTime frameDescription
The Modified 18-item Memorial Anxiety Scale for Prostate Cancerwithin 120 days of receiving counselingThis 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026