An exploration of men’s experiences of undergoing active surveillance for favourable-risk prostate cancer: A mixed methods study protocol: Beyond the Abstract

The present study was designed following completion of a systematic literature review [1, 2] which established that there was a paucity of high quality, methodologically appropriate research on the psychological wellbeing of men undergoing active surveillance (AS) for favourable-risk prostate cancer (PCa). Findings of the review indicated that appropriate comparison/control groups were lacking. Several studies included patients opting for active treatment (AT), others compared their results to reference values from general population normative data.

We however argue that it would be more appropriate to include a comparison group of men opting for curative treatment as well as a group of matched men with no PCa diagnosis; due to the high incidence of undiagnosed lower-risk PCa in men over 60 years [3], therefore those men in the control group will have similar physical functioning to those who had their PSA tested. From this it could then be extrapolated that any psychological differences between patients and age-matched volunteers would be attributable to PCa and the AS experience rather than physical symptoms of this age group or PCa.  

The outcome of previous studies should be queried as participants had already selected AS as a treatment course prior to study recruitment and it is therefore reasonable to hypothesise that patients with better psychological adjustment chose AS due to inherent increased ability to cope thus giving the studies an inherent selection bias. We are currently only aware of one study that attempted to manage this bias [4] by observing that AS participants who completed follow-up in the longitudinal study reported greater psychological dysfunction than those lost to follow-up, illustrating an additional potential bias in terms of the type of patient that remains involved in psychological studies.   

We are not aware of any study that utilised a mixed-methods (MM) design and only a limited number in the area are qualitative [5-7]. Uncertainty was explored qualitatively but the full range of psychological difficulties that can be present following a diagnosis of cancer were neglected. The lack of qualitative and MM research is limiting in that men on AS are potentially not being afforded the opportunity to express their interpretation of their own personal experiences. MM research would be of particular benefit in this area; maintaining generalisability while still providing an opportunity to gain a deeper understanding of patients’ experiences of AS and PCa generally [8]. The value of a MM design can be illustrated when we look at how men on AS describe uncertainty; qualitatively, participants describe overwhelming uncertainty that continued throughout AS [5-7], whereas in quantitative studies, uncertainty reportedly decreased over time [9-12], this discrepancy warrants further exploration. Our systematic review returned no qualitative papers relating to anxiety or depression; a qualitative study examining these outcomes may have presented different findings to the quantitative findings. This contradiction between qualitative and quantitative findings was found to be the case with sexual dysfunction in a previous study that used both qualitative and quantitative data collection methods [13]; this study found that in qualitative interviews participants discussed sexual dysfunction yet they reported favourable sexual function in quantitative questionnaires. A similar pattern emerged in the theme of illness uncertainty in our systematic review [1, 2]. 

We concluded that future research should include appropriate comparison groups, earlier baseline measures, and steps to minimise selection bias [1, 2]. Ideally, baseline assessment should occur prior to treatment decision-making with the aim of assessing patients over time to determine potential temporal variability thereby controlling for individual differences.  The value of longitudinal data was highlighted in the review, evident in the non-linear declines in anxiety observed in the included papers.

The published study protocol was designed to directly address the limitations highlighted in the systematic review. Patients will be recruited immediately post-diagnosis and prior to treatment decision making. These patients will then be followed up in 3 month intervals for a period of 12 months, therefore capturing the experiences of AS men in the same pattern of follow-up as the AS protocol until their first re-biopsy at 12 months. Due to the early baseline, i.e. prior to treatment decision making, it will not be possible to know which participants will opt for AS until the 3 month time-point, therefore all men eligible to undergo AS (Gleason score ≤7, PSA <20 ng/mL, T1a-T2b) [14] will be included and followed up in the same intervals regardless of treatment decision (i.e. AS or AT), to directly compare the psychological and physical impact of AT and AS. A control group of men with no diagnosis of cancer will also be recruited using peer-nomination to provide additional information with which to interpret the patients’ data. Peer-nomination is a recruitment strategy that involves patients nominating a male family member or friend within 5 years of their age who meets the appropriate inclusion/exclusion criteria [15]. Peer-nomination primarily matches participants based on age however previous studies have demonstrated that this method of recruitment also matches participants on other demographic factors e.g. education, relationship status [16, 17], and thereby minimising differences between patient and non-cancer groups. 

Anxiety, Depression, Illness Uncertainty, Decisional Regret, personality, Quality of Life (QoL), and prostate specific QoL will be assessed. Once follow up is complete, data will be analysed at both a between-groups level, i.e. AS patients, AT patients, and non-cancer men, and a within-groups level, i.e. individual differences in PCa group to identify potential predictors of treatment choice and/or resultant psychological adjustment. 

Quantitative Data from men opting for AS will be analysed, and using extreme case sampling 10-15 men will be identified and invited to participate in an in-depth qualitative semi-structured interview. This interview will allow us to further explore the results of Phase 1 surveys, and allow men to speak freely about their experience. By inviting those who demonstrate psychological adjustment at both ends of the spectrum it will therefore allow us to identify potential reasons for the differential adjustment with the view to develop methods of supporting those men who may struggle with the AS experience. 

To our knowledge, this study will be the first to include an early baseline measurement taken before treatment modalities have been decided; adopt a control group of men not diagnosed with cancer; use power calculations to ascertain required sample size; and combine qualitative and quantitative methodologies. The purpose of adopting these innovative methodological strategies is to attain a more complete picture of these men's experiences. Study results can be expected in 2017. 

Written by: Eimear Ruane-McAteer, Joe O'Sullivan, Sam Porter, Lionne Venderbos, Gillian Prue

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