2.1.1. Inclusion Criteria
This study recruited a wide range of cancer patients in different settings and at different stages of illness. Furthermore, participants with all types and sites of cancer were eligible for inclusion, in a deliberate contrast to much cancer research, which focuses on specific populations when measuring factors which affect quality of life and distress. Varied stages and sites of cancer helped to expand upon whether the utility of response styles varied with illness context, such as whether life was in imminent danger, or whether responses had an overall impact on the wider cancer population. As death anxiety theory implies that threats to life may increase anxiety and avoidant responses, the inclusion of a range of cancer stages and also a palliative sub-group allowed us to see whether results would vary by the stage of cancer; although it was also noted that the severity of illness perceptions would not necessarily be reflective of objective threat to life.
2.1.2. Recruitment Procedures
Participants were recruited from Nottingham City Hospital, Kingsmill Hospital, John Eastwood Hospice, and from Nottinghamshire county, via the Macmillan community support service team. Participants were approached by clinical gatekeepers, who were doctors and nurses within the cancer services. Gatekeepers were initially approached by email, and were met with several times to discuss the study, before agreeing to take part by approaching potential participants and handing out questionnaire packs. Clinical gatekeepers also helped to shape the demographic and clinical questions asked on the questionnaires, and also to delineate the processes involved with participants completing and sending back questionnaires. A prompt sheet was designed in consultation with the gatekeepers (Appendix A), so that they could each provide participants with consistent information about the study, before asking them to read the participant information sheets (Appendix B) and to fill out the consent forms and questionnaires if they wished to take part (Appendices C & D). It was decided that providing participants with stamped, addressed envelopes would
both preserve the confidentiality of responses in clinical settings, and potentially reduce any impact that the risk of clinicians seeing completed questionnaires might have on participants’ responses. Providing envelopes also eased the burden on clinicians’ workloads, as they were not involved with collecting questionnaires in or handing them back to the researcher; time-consuming activities which could have impacted upon their clinical duties and was therefore not optimal for patient care. Recruitment of participants took place between September 2015 and February 2016.
2.1.3. Online and Paper Participation
The recruitment strategy of using both paper and online versions of the questionnaire was designed to target maximum numbers of participants, in as broad a number of contexts as possible. The online questionnaire allowed recruitment to be extended beyond hospital settings, thereby targeting participants who no longer had cancer, and whose experiences may therefore have been different.
Participants were able to participate in the study online, and were targeted via advertisements placed on social media platforms (Facebook and Twitter), and online cancer fora, such as Cancer Chat. Permissions were sought from website administrators via email before advertisements were placed on these fora. Online participants were asked to create a pseudonym, by combining the month of their birth with the first three letters of their mother’s maiden name, for example ‘03FOR’. These pseudonyms were then used to record and track participants’ data, so that their responses could be matched up if they participated in a follow-up questionnaire three months later.
Paper questionnaires were each issued with an assigned code, pertaining to the hospital or hospice where they were given out, e.g. ‘NC31’ = Nottingham City Hospital, participant number 31. This identifier allowed the researcher to track which gatekeepers were issuing questionnaires, and to liaise with any who were not, to see whether they were experiencing issues. The unique identifiers also allowed for questionnaire responses to be stored separately from consent forms displaying participant names and contact details, in line with data
protection procedures. However, as both paper questionnaires and consent forms were labelled with corresponding codes, this allowed a participant’s data to be withdrawn if requested, by matching up their code with their named consent form. This was a precautionary process but was not required, as no participants requested the withdrawal of their data from the study.
2.1.4. Data Storage and Coding
Data were stored on an encrypted data stick, upon which was a password- protected spreadsheet. Data on the spreadsheet were identifiable only by participant codes, with the corresponding consent forms -listing names and contact details - stored in a locked filing cabinet at the University of Lincoln. The participant codes allowed for data tracking, in order to monitor when participants had first completed the battery of questionnaires, and when they should be issued with a follow-up three months later, provided they had consented to this. Follow-up participant information sheets, consent forms, and questionnaires (see Appendices E & F) were mostly issued online, via a link sent to participants in an email; with the exception of three participants who had opted to be sent a paper questionnaire by post.
Upon receipt of completed questionnaires and consent forms, the data were stored securely in a locked filing cabinet in the University of Lincoln, only accessible to the departmental administrators and research team. The data will be stored securely for five years before being destroyed, in line with the Data Protection Act (1998) and the British Psychological Society Code of Ethics and Conduct (2009). Online data was stored securely using an online survey tool called Qualtrics, where it was password-protected and inaccessible to any external party. Participant names were not required for the online arm of the study, as participants created and were tracked by their unique pseudonyms.
2.1.5. Ethics
The study was granted ethical approval by the University of Lincoln Ethics Committee, and the East Midlands Research Ethics Committee (REC reference 14/EM/1224), in January 2015 (Appendix G). Further amendments made to the
processes of recruitment and data collection received ethical approval in May 2015 (Appendix H).
Ethical considerations in this study were informed by feedback from the NHS ethics committee, meetings with clinical gatekeepers and research supervisors, and common practices in the literature. Research has suggested that cancer patients find participating in research to be beneficial, as they are able to share their experiences and contribute to future practice (Pessin et al., 2008). Evidence for this interest was shown by the 45 participants who opted to be notified of the study results once they had been analysed. However, the primary concern voiced by the NHS ethics committee was whether issuing participants with cancer-related questionnaires was likely to induce distress. Although the questionnaire battery comprised standardised measures which have been issued to cancer participants in previous research, the ethics committee’s concern required the inclusion of several statements throughout the questionnaire to preface the nature of the questions, and to emphasise that participants had the right to either leave out questions, or to withdraw from the study at any time. Furthermore, contact details for the research team were given in participant information sheets, alongside sources of support participants could consult if they felt distressed after completing the measures. Participants were asked to read information sheets about the study prior to signing consent forms, and filling out any questionnaires. The questionnaire was long enough to measure a range of processes and outcomes, but due consideration was given to its length, as participants may not have been feeling well. Short-form versions of two subscales were included in order to ensure participants were not over-burdened by a lengthy and very time-consuming questionnaire battery.
Clinical gatekeepers were appointed in order to mitigate the chances of vulnerable participants being approached and asked to participate in the study. It had also been agreed that participants’ consultants or lead professionals would be made aware that they were taking part, but as the gatekeepers held those roles, a separate process for this notification was not necessary. A further ethical process decided upon was that prior to follow-up, the names of
consenting participants would be checked with gatekeepers. This was to check whether it was still appropriate to contact that person, given that the nature of disease means their condition may have deteriorated. In three cases, participants had died between initial participation and follow-up, and this safeguard therefore prevented any inappropriate contact being made, e.g. sending out a follow-up questionnaire, if the participants had chosen to be contacted by post.