Scaled collection of socioEconomic and Quality of Life data from patients undergoing allogeneic haematopoietic cell transplantation (SEQoL)

Research summary

1. Study design 1.1. Patient and Public Involvement (PPI) PPI remains central to this project,with the Anthony Nolan Patient Services team co-developing the proposal alongside a Patient Advisory Group (PAG). The PAG,consisting of 6 allogeneic HCT patient representatives,has been expanded to include members from underserved and minority groups to ensure diverse perspectives. PAG members actively participated in online meetings and in-person workshops,contributing to research design and sampling timepoints,providing feedback on questionnaire content and measures,and assisting in the development of patient-facing study resources,such as participant information sheets and consent forms. The PAG will remain engaged throughout the study,providing input on decision-making,suggesting solutions for recruitment challenges,and offering feedback on proposed protocol amendments. As data analysis progresses,PAG members will actively participate in interpreting and discussing findings,co-presenting results. Their involvement will extend to shaping communication and dissemination strategies for diverse audiences,including patient groups. Furthermore,we plan to involve the PAG in contributing to publications,ensuring their input is appropriately reflected in all research outputs. 1.2. Research overview SEQoL is a multicentre,prospective,observational,non-randomised study in adult (≥18yrs) patients undergoing allogeneic HCT. The study will commence recruitment initially at 3 UK transplant centres: • Churchill Hospital,Oxford • King’s College Hospital,London • Manchester Royal Infirmary,Manchester The study will then progressively open recruitment to involve a minimum of 15 UK transplant centres. This expansion will be systematically carried out by planning site engagement and identifying potential Principal Investigators at each participating site. 1.3. Participant eligibility criteria The inclusion criteria are adult patients (≥18 years old) scheduled to undergo allogeneic HCT for both malignant and non-malignant conditions,provided they have the capacity to provide informed consent. Patients who are unable to read or write will be excluded. 1.4. Data collection • Self-reported data All study participants will be asked to complete an electronic questionnaire at each time interval of the study (Baseline,Day 0,Day 28,Day 100,Day 180,Day 270,and Day 365). The SEQoL questionnaire includes the following sections: a. Health characteristics: Participants will also be asked to self-report the type of cancer or blood disorder they were diagnosed with,date of their diagnosis,and the date of their transplant. b. Demographic and objective socioeconomic characteristics: Demographic data including age,sex,marital status,living arrangements,and ethnicity will also be collected via the self-report questionnaires. Individual postcode data will used to obtain the Index of Multiple Deprivation (IMD) score,a relative deprivation score based on residential location. IMD is the official measure of relative deprivation for small areas in the UK. It ranks every small area according to income,employment,health,education,housing,access and child poverty. Higher scores of IMD indicate higher SES. Data on individual socioeconomic position including (housing tenure,income,education and occupational status) will also be collected using items adapted from the Standard Occupational Classification from the UK Office of National Statistics (ONS). c. Subjective socioeconomic characteristics: Using the MacArthur Ladder scoring,data will be collected at each questionnaire interval to identify the participant’s personal belief of their own standing within a) UK Society and b) their own community. d. Quality of life (QoL): The Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) version 4 is a 50-item questionnaire designed to assess the QoL in HCT recipients. It evaluates several domains,including physical,social/family,emotional,and functional wellbeing,as well as transplantation-specific concerns. FACT-BMT completion times can be as short as 10 minutes when using online forms. e. Assessment of symptom burden: The Lee Symptom Scale (LSS) is a 30-item tool designed for assessing symptoms of cGVHD across seven domains: skin,mouth,eyes,lungs,psycho-emotional,vitality,and nutrition. Completing the scale may take as little as 2 minutes. Collection of this data will enable the exploration of the functional and systematic consequence of the long-term effects of HCT,including the impact of cGVHD using validated self-reporting measures. • Confirming participant information and vital status To ensure accurate self-reported data,research sites will verify information against hospital records. This process will guide the Anthony Nolan Patient Services Research team in distributing questionnaires effectively. Research sites will also confirm participant details and collect NHS numbers,facilitating data linkage with BSBMTCT or other registers. Each research site will be asked to confirm the following details: • Participant characteristics: o Initials o NHS number o Date of birth • Disease-related characteristics: o Date of transplant • Vital status: o Dead,alive o Main cause of death – relapse or progression/persistent disease,HCT related cause,unknown,other Study records will be provided to the site in accordance with the site visits and monitoring activities outlined in the protocol. Sites will be asked to cross-check the study records against clinical records to confirm participant characteristics,date of transplant,and vital status information of patients. • Alternative arrangements to complete the questionnaires It is recognised that some patients may not have an email address or access to one. Where this arises,a member of staff from the transplant centre team will contact the study team and arrangements will be made to support the patient in being able to participate in the study. Alternative arrangements to complete the questionnaire may include mail-out of paper copies with freepost return envelope,language line translation,and text links. • Discontinuation/withdrawal of participants In consenting to participate in the study,participants are consenting to data collection at each time-point. A participant can withdraw from the study at any time without providing a reason,but they will be given the opportunity to disclose their reasons if they wish. As outlined within the participant information sheet,if a participant withdraws or discontinues participating within the study any data collected up to that point will be included within the analysis. • End of Study The study will be closed to recruitment once 712 patients have been recruited across all research sites and all recruited patients have completed the Day 365 questionnaire. We anticipate the completion of recruitment in SEQoL (Phase 2) by April 2026. The period of data collection may be extended and additional HCT centres invited to participate in recruiting participants. • REDCap Data in this study will be collected via REDCap - a secure web application for building and managing online surveys and databases (https://www.project-redcap.org/). REDCap assigns each participant's data (a record) a unique identifier that is not otherwise linked to a participant's personal data. REDCap is HIPAA-compliant. Fields in REDCap provide users with the option of de-identifying their data. Once data collection is complete the project will be archived – data will be exported,and unless specifically requested for the purpose of linkage,validation or future analyses,any identifier fields will be removed from the data. An econsent form (consistent with the consent form submitted on IRAS for REC & HRA review) has been built on REDCap. To provide econsent,participants will be asked to complete the digital form on REDCap in the same manner as they would the paper copy including acknowledging the consent clauses,and providing their full name,signature,and date of consent. 2. Sampling: Sample size and sampling technique Data from PrEQoL (Phase 1) was used to inform the sample size calculation for SEQoL (Phase 2). As an indicative estimate,in SEQoL as data collection was refined and scaled from 3 HCT centres to 15 adult HCT centres,we will likely recruit a minimum of 712 HCT patients. This calculation was derived from our feasibility findings in PrEQoL showing an average recruitment rate of 1.5 patients per week per site,factoring in 10% of declines and drop-outs,and upon BSBMTCT register data,indicating that 1197 adult allogeneic HCT were undertaken in 2021 across 24 HCT centres. 3. Participant identification,recruitment and consent • Participant identification All adult patients who undergo allogeneic HCT at the study sites for the duration of the study will be considered potential participants for SEQoL. The Principal Investigator and/or designated research staff at each participating site will identify and approach patients due receive an allogenic HCT at their centre to identify potential participants. All potential participants will be reviewed against the study inclusion and exclusion criteria to ensure enrolment of suitable patients only. • Participant recruitment Potential study participants will be approached by approved research staff,who will offer them a choice between receiving the Participant Information Sheet (PIS) in either paper or electronic format based on their preference. Each site will receive electronic handheld tablets/devices from Anthony Nolan,enabling participants to access information on-site. Patients should be given a minimum of 24 hours to consider their participation in the study. If a patient is identified in the clinic without having received the PIS before their appointment,consent can be obtained on the same day,ensuring they have adequate time to understand their involvement in the study. This will ensure that patients can remain engaged in the study,preventing the need for them to return to the clinic for consent,particularly for those residing at a distance from the research centre. This should be clearly documented in the patient notes. Study sites will be given a screening log to track all patients approached for the study. • Participant consent Formal written/econsent will be obtained at study enrolment. Patients willing to take part in this study will be asked to review the study consent form and complete the consent process in the transplant centre either via traditional paper forms (written consent) or using a handheld tablet/device (econsent). In the study development and feasibility outcomes of PrEQoL,it was found that HCT centres effectively collected econsent with a high participant response rate. Therefore,econsent will be the primary collection method. Paper physical copies will also be available,allowing participants or HCT centres to express a preference for written consent if desired. If the participant consents electronically the econsent form will automatically be logged by the study office at Anthony Nolan. If a participant consents via paper physical copies of the consent forms will be posted or emailed via secure NHS.net email address to the main study office (Anthony Nolan,Heathgate,London,UK). A copy of the consent form will be sent to participants to retain in the same format they provided the original. At the beginning of each survey timepoint (Baseline,Day 0,Day 28,Day 100,Day 180,Day 270,Day 365) participants will be reminded that by submitting the questionnaire they are consenting to the use of their personal data for the SEQoL study. Participation in this study is voluntary and no expenses will be paid to patients for their participation in this study. Participants will be asked to provide their preferred contact details (name,address,telephone number,email) for communication and to receive questionnaires and reminders from the Anthony Nolan Patient Services Research team. 4. Rationale and Aim: In the UK,there is currently no standardised practice for collecting baseline socioeconomic status (including education,marital status,dependents,occupation,work status,household income),race and ethnicity,gender,and prospective QoL data for HCT patients. There is an urgent need to examine how this data can be systematically collected,analysed,and utilised within the UK transplant community to promote equity of access,help inform and understand differences in transplant outcomes,and improve transplant services,clinical outcomes,and patient experience. SEQoL aims to assess the effectiveness of prospective scaled collection of demographic (specifically ethnicity and socioeconomic status) and quality of life data among allogeneic HCT recipients via a digital web-based tool provided by Anthony Nolan. The primary objective is to evaluate the feasibility of this scaled collection,measuring percentage uptake (recruitment rate),percentage drop-out (participant retention),and data completeness at Baseline,Day 0,Day 28,Day 100,Day 180,Day 270,and Day 365.

Principal Investigator

Sally Springett

Contact us

Email: Latephasehaematology@ouh.nhs.uk

IRAS number

330195