Quality of Life of Patients With Locally Advanced and Metastatic Prostate Cancer

Prospective Epidemiological Study to Determine the Variation in the Quality of Life of Patients With Locally Advanced and Metastatic Prostate Cancer (PROS-PROSQoLI Study)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02853409

Acronym

PROS-PROSQoLI

Enrollment

628

Registered

2016-08-02

Start date

2014-01-31

Completion date

2015-12-31

Last updated

2018-12-21

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 is to evaluate possible changes in quality of life related to health (HRQL) in locally advanced and metastatic prostate cancer patients, after one year of follow-up.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Men ≥ 18 years old * Symptomatic prostate cancer patients who present symptoms due to prostate cancer disease * Capacity to comply with the protocol * Patient with an expected survival \> 12 months

Exclusion criteria

* Patients who are also participating in any other clinical study * Patient with other malignant diseases, apart from prostate cancer

Design outcomes

Primary

Measure	Time frame
Quality of life evolution, using the validated Prostate Cancer Specific Quality of Life Instrument (PROSQOLI)	12 months

Secondary

Measure	Time frame	Description
Anthropometric Characteristics - Body Mass Index	Baseline	—
Prostate-specific Antigen (PSA)	Baseline, 12 months	—
Testosterone level	Baseline, 12 months	—
Digital rectal examination	Baseline, 12 months	—
Socio-demographic characteristics (percentage of patients (a) living married or living with a partner, (b) had completed primary studies, (c) retired or pensioners, (d) patients had a family history of PrCa)	12 months	—
Anxiety questionnaire (Hospital Anxiety and Depression scales-HAD)	12 months	—
Change in general health status perception (from either patient or physician perspective)	12 months	Assessment of health in relation to Prostate Cancer, the options are: very good, quite good, slightly good, neither good nor bad, slightly bad, quite bad or very bad.
Quality of life using EQ-5D questionnaire	12 months	—
Percentage of patients who have undergone previous treatment (surgery, radiotherapy and hormonotherapy)	12 months	—

Countries

Spain

Outcome results