Treatments and assessments
The decision to prescribe treatment must have been freely
undertaken by the clinician prior to considering enrolling a
patient in the study. Treatment administration was, therefore,
independent and dissociated from participation in the study.
No study-specifi clinical tests were required; all medical
data collected on electronic case report forms (eCRFs) were
expected to be part of standard patient records. Common
chemotherapy regimens for each cancer type were prespecifid in the eCRF. For simplicity, these were referred to as
“standard” regimens. Regimens not listed in the eCRF could
be added manually by the treating clinician and were referred
to as “non-standard” regimens.
FACT-F subscale scores and fatigue VAS scores were
used to assess QoL. FACT-F scores range from 0 to 52, with
higher scores indicating better QoL. VAS scores range from
0 to 100, with 0 being least fatigued. Patients completed electronic fatigue assessments during visits (no more frequently
than every 7 days) for receipt of chemotherapy and/or ESA
treatment.