A Study to Investigate the Impact of Abiraterone Acetate and Enzalutamide on Health-related Quality of Life, Participant-Reported Outcomes, and Medical Resource Use in Metastatic Castration-resistant Prostate Cancer Participants (AQUARiUS)
|ClinicalTrials.gov Identifier: NCT02813408|
Recruitment Status : Active, not recruiting
First Posted : June 27, 2016
Last Update Posted : February 8, 2018
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||187 participants|
|Official Title:||Prospective Multi-country Observational Study to Investigate the Impact of Abiraterone Acetate and Enzalutamide on Health-related Quality of Life, Patient-reported Outcomes, and Medical Resource Use in Metastatic Castration-resistant Prostate Cancer Patients|
|Actual Study Start Date :||June 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||April 2018|
Participants with Prostate Cancer (abiraterone acetate)
Participants with metastatic castration resistant prostate cancer (mCRPC) will receive abiraterone acetate at the discretion of his treating physician.
Participants with Prostate Cancer (enzalutamide)
Participants with metastatic castration resistant prostate cancer (mCRPC) will receive enzalutamide at the discretion of his treating physician.
- Health Related Quality of Life (HRQoL) [ Time Frame: 12 months ]
- Fatigue (BFI-SF) [ Time Frame: 12 months ]Brief Fatigue Inventory-Short Form (BFI-SF) assess the severity of fatigue and the impact of fatigue on daily functioning. BFI-SF is a 4 item questionnaire. Each item is assessed on a 11point scale, ranges from 0 (No Fatigue) to 10 (As bad as you can imagine). Average from all 4 items will be used to derive the final score.
- Pain (BPI-SF) [ Time Frame: 12 months ]Brief Pain Inventory-Short Form (BPI-SF) measures severity of pain, impact of pain on daily function, locations of pain, pain medications, and amount of pain relief in the past 24 hours or the past week. The BPI-SF includes 4 items measuring the intensity of pain which make up the pain intensity sub scales, assessed using 11 point numerical rating scales from "0"= no pain to "10" = pain as bad as you can imagine; 7 items that assess how much pain has interfered with 7 daily activities which make up the pain interference sub scale, assessed on a scale of 0, "Does not interfere" to 10, "completely interferes." This sub scale is typically scored as the mean of the 7 interference items; An additional item on the extent of pain relief.
- Cognitive Function (FACT-Cog) [ Time Frame: 12 months ]The Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) is a validated, 37 item, subjective neuro-psychological instrument designed to evaluate cancer participants perceived cognitive deterioration on their quality of life. The FACT-Cog is composed of 37 single items ranging from 04. Based on these single items 4 sub scales are calculated as perceived Cognitive Impairments (20 items; score range 0-80), impact On QOL (4 items; score range 0-16), comments From Others (4 items; score range 0-16), perceived Cognitive Abilities (9 items; score range 0-36).
- Medical Resource Use (MRU) [ Time Frame: 6 months prior to baseline until the end of the follow-up period (up to 18 months) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813408
|Holstebro N/A, Denmark|
|Besancon Cedex, France|
|Chalon Sur Saône, France|
|Saint Mande, France|
|Berkshire, United Kingdom|
|Birmingham, United Kingdom|
|Bolton, United Kingdom|
|Derby, United Kingdom|
|Glasgow, United Kingdom|
|Lancaster, United Kingdom|
|Middlesbrough, United Kingdom|
|Oldham, United Kingdom|
|Sutton, United Kingdom|
|Wolverhampton., United Kingdom|
|Study Director:||Janssen Pharmaceutica N.V., Belgium Clinical Trial||Janssen Pharmaceutica N.V., Belgium|