PrEQoL: prospective collection of QoL data among HCT recipients
Research type
Research Study
Full title
PrEQoL: A Prospective study to Evaluate the collection of SocioEconomic and Quality of Life data in patients undergoing allogeneic haematopoietic cell transplant
IRAS ID
314390
Contact name
Robert Danby
Contact email
Sponsor organisation
Anthony Nolan
Duration of Study in the UK
0 years, 8 months, 0 days
Research summary
Background: There is growing recognition that inequities in patient outcome and quality of life following haematopoietic cell transplant (HCT) may be due to social and demographic factors. To improve understanding about the impact of social determinants of health on patient outcomes, routine collection of patient demographic status (including age, gender, race, ethnicity, socioeconomic status) and patient-reported outcomes is required. Only with these data can strategies to level-up and reduce inequity be developed.
Aims & objectives: The purpose of this project (PrEQoL) is to pilot the 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.
As PrEQoL (Phase 1) will inform the methods used during (SEQoL an SEQoL & Co (Phase 2 and 3), this protocol only refers to Phase 1 ‘Pilot study to Evaluate the 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 and QoL questionnaire at four timepoints: before transplant conditioning, on the day of their transplant, 28 days post-transplant and 100 days post-transplant. Patient-reported outcome measures of demographic status (including objective and subjective SES) and QoL domains of anxiety, depression, fatigue, pain, physical function, sleep disturbance, satisfaction with participation in social roles will be collected.
Planned analysis: Data from PrEQoL will provide insight on the feasibility of undertaking prospective demographic and QoL data collection among allogeneic HCT patients. The primary outcomes of PrEQoL is percentage uptake (recruitment rate) at baseline and percentage drop-out (participant retention) at each data collection interval (Day 0, Day 28, and Day 100). Secondary outcomes include completion rates of outcome measures and patterns of missing data and participant experience and satisfaction with participation within the study (collected via feedback forms).
Impact: We anticipate the findings from PrEQoL, SEQoL and SEQoL & CO will influence planning and provision of future HCT services. Specifically, this research programme will inform targeted service improvements to address inequity at both the individual patient level and the system level across NHS transplant services. The findings from this research will be particularly relevant to NHS commissioning and providers of transplant services.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0027
Date of REC Opinion
17 Jan 2023
REC opinion
Favourable Opinion