Prostate Cancer
Conditions
Brief summary
The objective of the study is to compare the evolution over 6 months of Health-Related Quality of Life (HRQOL) among different age groups in subjects with prostate cancer treated with GnRH agonist therapy.
Detailed description
Relevant data collected as part of routine medical care will be captured on an electronic Case Report Form (eCRF). Investigator-subject questionnaires and subject self-questionnaires answers will be collected in a paper booklet. This study is non-interventional, thus if some assessments, are not routinely performed by the investigator, he/she will not complete the corresponding sections in the eCRF.
Interventions
OTHERData collection
Subjects will be treated in accordance with usual medical practice during their participation in this study. No additional assessments or tests will be required.
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject presenting with histologically confirmed prostate cancer * Subject of 60 years and older * Subject eligible to start GnRH agonist therapy, either as monotherapy or adjuvant therapy, and for whom one of these treatments was selected voluntarily by the investigator, prior to the start of the study * Subject giving his written consent to participate in the study * Subject able to complete questionnaires
Exclusion criteria
* Subject simultaneously participating in a clinical trial * Subject who previously received a hormonal therapy during the last 6 months before inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QOL) as evaluated by Quality of Life Questionnaire-Elderly 14 items (QLQ-ELD-14) | Change from baseline at 6 months | Evolution overall and in subgroups of age (\[60-\<70\], \[70- \<75\] and ≥ 75 years). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HRQOL Visual Analog Scale (VAS) score | Baseline and 6 months | Subjects evaluate level of satisfaction with their general health status by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'. |
| Health status scores as evaluated by G8 questionnaire | Baseline and 6 months | — |
| Overall condition VAS score | Baseline and 6 months | Subjects evaluate level of satisfaction with their general health status by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'. |
| Urinary function scores as evaluated by QOL question of the International Prostate Symptom Score (IPSS) | Baseline and 6 months | Subjects will be asked to indicate the score corresponding to their evaluation of their quality of life related to urinary symptoms in response to the following question 'If you were to live the rest of your life with this way of urinating, would you say you would be:' on a scale from 0 (very satisfied) to 6 (very upset). |
| Urinary function score VAS | Baseline and 6 months | Subjects evaluate level of satisfaction with their urinary function by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'. |
| Sexual function scores as evaluated by 3 questions on sexual domain of the Urolife Benign Prostatic Hyperplasia-Quality Of Life 9 (BPH-QoL 9) questionnaire | Baseline and 6 months | — |
| Sexual function VAS score | Baseline and 6 months | Subjects evaluate level of satisfaction with their sexual function by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'. |
| Cognitive status scores as evaluated by Mini Mental State (MMS) | Baseline and 6 months | — |
| Memory VAS score | Baseline and 6 months | Subjects evaluate level of satisfaction with memory (your capacity to remind events or persons you meet) by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'. |
| Mood scores as evaluated by mini Geriatric Depression Scale (GDS) questionnaire | Baseline and 6 months | Subjects will be asked four questions and their responses 'Yes' or 'No' will be scored from 0 to 1. |
| Mood VAS score | Baseline and 6 months | Subjects evaluate level of satisfaction with mood (your feeling of happiness, confidence and serenity) by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'. |
| Motricity scores as evaluated by G8 questionnaire specific domain (3rd item) | Baseline and 6 months | Mobility will be scored as follows 'Bed or chair bound' = 0, 'Able to get out of bed/chair but does not go out' = 1, 'Goes out' = 2 |
| VAS motricity score | Baseline and 6 months | Subjects evaluate level of satisfaction with motricity (your ability to move by yourself in your home or outside) by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied' |
| Autonomy question | Baseline and 6 months | Subjects respond either 'yes' or 'no' to the following autonomy question 'Is the patient living independently at home?' |
| Autonomy VAS score | Baseline and 6 months | Subjects evaluate level of satisfaction with autonomy (your ability to manage your life alone at home or outside) by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'. |
Countries
France
Contacts
STUDY_DIRECTORIpsen Medical Director
Ipsen
Outcome results
None listed