SEQoL: scaled collection of QoL data among HCT recipients
Research type
Research Study
Full title
Scaled collection of socioEconomic and Quality of Life data from patients undergoing allogeneic haematopoietic cell transplantation
IRAS ID
330195
Contact name
Robert Danby
Contact email
Sponsor organisation
Anthony Nolan
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Background: There is a growing consensus that inequities in patient outcomes following haematopoietic cell transplant (HCT) may result from social and demographic factors. Routine collection of patient demographic data (age, gender, race, ethnicity, socioeconomic status) and patient-reported outcomes is essential to understand the impact of social determinants of health on patient outcomes and develop strategies to address and reduce inequity.
Aims & objectives: The purpose of SEQoL is to examine the effectiveness of scaled prospective collection of demographic (namely ethnicity and socioeconomic status, SES) and Quality of Life (QoL) data among allogeneic HCT recipients using a digital web-based tool hosted by Anthony Nolan.
The programme of research is planned in three phases:
Phase 1: PrEQoL - A Pilot study to Evaluate the collection of socioeconomic and Quality of Life data among patients undergoing allogeneic haematopoietic cell transplantation.
Phase 2. SEQoL - Scaled collection of Socioeconomic and Quality of Life data among patients undergoing allogeneic haematopoietic cell transplantation.Phase 3. SEQoL & CO - Linking Socioeconomic and Quality of Life data to routinely collected Clinical Outcomes data.
PrEQoL (Phase 1) informed the methods to be used in SEQoL and SEQoL & Co (Phase 2 and 3). This protocol only refers to Phase 2 ‘SEQoL - Scaled collection of Socioeconomic and Quality of Life data among patients undergoing allogeneic haematopoietic cell transplantation.’
Method: Adult (≥18 years) allogeneic HCT patients will be invited to complete a brief demographic, QoL and symptom burden questionnaire at seven timepoints: before transplant conditioning, on the day of their transplant, and at 28, 100, 180, 270, and 365 days post-transplant. Patient-reported outcome measures of demographic status (including objective and subjective SES), QoL domains of physical wellbeing, social/family wellbeing, emotional wellbeing, functional wellbeing and transplantation-related concerns, as well as symptom burden of GVHD will be collected.
Planned analysis: Data from SEQoL will provide insight on the feasibility of undertaking prospective demographic and QoL data collection on a large scale among allogeneic HCT patients. The primary outcome of SEQoL is the percentage uptake (recruitment rate) at baseline, percentage drop-out (participant retention) and data completeness (completion rate) at each data collection interval (Baseline, Day 0, Day 28, Day 100, Day 180, Day 270 and Day 365). Secondary outcomes include the temporal change in QoL outcomes and symptom burden of cGVHD in the first year post-transplant.
Impact: We anticipate the findings from PrEQoL, SEQoL and SEQoL & CO will shape the planning and delivery of future HCT services. This research programme will guide targeted service improvements to address inequity at both the individual patient level and the system level across NHS transplant services. The research outcomes will be particularly relevant to NHS commissioning and transplant service providers.
REC name
London - Riverside Research Ethics Committee
REC reference
24/PR/0206
Date of REC Opinion
30 Apr 2024
REC opinion
Further Information Favourable Opinion