Pilot study of patient reported outcomes with Trabectedin
Research type
Research Study
Full title
A pilot study of patient reported outcomes when treated with Trabectedin for unresectable and/or metastatic soft tissue sarcoma
IRAS ID
196733
Contact name
Daniel PH Stark
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Trabectedin improves cancer outcomes in advanced soft tissue sarcoma, in particular lipo- and leiomyo- sarcomas after failure of conventional chemotherapy, with a low level of symptomatic toxicity. However most patients who benefit do so by the cancer stopping growing (becoming stable) rather than it shrinking.
Patient reported outcome measures (PROMs) are central to understanding the impact of cancer treatments on patients. Treatment may control cancer growth, and even sometimes modestly improve the length of life, but at the expense of disruption of lifestyle, and of toxicities. It is very important we use PROMs to evaluate the balance between these risks and benefits to understand the overall impact of the treatment.It remains poorly described whether patients report improved outcomes during palliative chemotherapy with trabectedin, using high quality questionnaires, and how this may vary with the clinical effects and duration of the treatment and characteristics of the patient.
Therefore we intend to examine how feasible it is to collect patient reported outcome measures prospectively during English NHS administration of Trabectedin and with this to explore the pattern of patient reported outcomes.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0446
Date of REC Opinion
21 Oct 2016
REC opinion
Favourable Opinion