The EASEMENT Study

• Research type

  Research Study

• Full title

  Observational study to evaluate the burden of injected and oral treatment formulations in the treatment of multiple myeloma patients. The EASEMENT Study.

• IRAS ID

  235992

• Contact name

  Neil Rabin

• Contact email

  neil.rabin@nhs.net

• Sponsor organisation

  Takeda

• Duration of Study in the UK

  0 years, 11 months, 1 days

• Research summary

  In order to understand the burden of multiple myeloma and to identify the patients’, caregivers’ and physicians’ perspective on currently available treatment options, this study has been designed in real-world settings across several countries (including the UK).
  This study has 3 components:
  1) Cross-sectional collection of patients' and caregivers' self-reported health outcomes. This information will be collected via different study questionnaires which measure treatment satisfaction and preferences, health-related quality of life, productivity loss and non-health care related costs such as travel to health care center or professional caregivers.
  2) Retrospective chart review of the patients' medical files will be reviewed in order to collect information on health care resource use from the time of multiple myeloma treatment initiation to date of study inclusion.
  3) Time and motion will be a questionnaire targeted to pharmacists and nurses who prepare the chemotherapy treatment for multiple myeloma patients in order to understand the time and cost in hospital associated with each of the different multiple myeloma treatment options.

  Only the cross-sectional and retrospective chart review components will involve patients with diagnosed with multiple myeloma and their caregivers. Patients must have received at least one anticancer therapy at the study inclusion date. It will also involve informal caregivers (at least 18 years of age or older) of the included patients with multiple myeloma.
  In the UK arm of the study, NHS hospital sites will be recruited to participate in the study. The study is expected to last 12 months (this includes 5 months for regulatory affairs and contracting/study set-up at sites, 4 months for enrolment and 3 months for data collection).

• REC name

  London - Bromley Research Ethics Committee

• REC reference

  18/LO/0256

• Date of REC Opinion

  13 Feb 2018

• REC opinion

  Favourable Opinion