Clinical trial NCT02347852: Assessment of Physical Activity During Therapy With Regorafenib for Metastatic Colorectal Cancer
Official title: Assessment of Physical Activity During Therapy With Regorafenib for Metastatic Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-01-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants of NIS CORRELATE (NCT02042144, Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings) in Austria

Brief summary: The purpose of this trial is to quantitatively assess the average amount of physical activity that patients are capable to perform while receiving regorafenib for the treatment of metastatic colorectal cancer. The assessment of this reference value, measured by CE (Conformité Européene)-certified pedometer and international physical activity questionnaire, will allow an estimation on the feasible amount of physical activity for patients in this therapeutic setting.

This study is available for patients who are included in the global non-interventional study CORRELATE (Safety and efficacy of regorafenib in metastatic colorectal cancer patients; NCT01843400) in Austria.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with mCRC who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator's routine treatment practice to prescribe regorafenib.
* Patients enrolled in NIS CORRELATE in Austria
* Signed patient informed consent for local OS

Exclusion Criteria:

* Subjects unwilling to complete all questionnaires involved in the local OS
* Subjects unwilling to wear the pedometer

Primary outcomes:
measure: Amount of physical activity assessed by a pedometer (smartLAB) and an international physical activity questionnaire
timeFrame: At 3 months
Secondary outcomes:
measure: Relation of the amount of physical activity to QoL (Quality of Life) data assessed in CORRELATE (NCT02042144, 'Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings')
timeFrame: At 3 months
measure: Relation of the amount of physical activity to fatigue data assessed in CORRELATE (NCT02042144, 'Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings')
timeFrame: At 3 months
measure: Relation of the amount of physical activity to DCR (Disease Control Rate) data assessed in CORRELATE (NCT02042144, 'Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings')
timeFrame: At 3 months
measure: Relation of the amount of physical activity to OS (Overall Survival) data assessed in CORRELATE (NCT02042144, 'Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings')
timeFrame: At 3 months
measure: Relation of the amount of physical activity to PFS (Progression Free Survival) data assessed in CORRELATE (NCT02042144, 'Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings')
timeFrame: At 3 months
Other outcomes:
Locations:
city: Multiple Locations
country: Austria
facility: Klinikum Kreuzschwestern Wels GmbH
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: