Identification of participants
Prostate cancer patients
Patients diagnosed with favourable risk PCa (Gleason score ≤7, PSA <20 ng/mL and clinical stage T1-T2b) [16] who are eligible for AS will be recruited from the Northern Ireland Cancer Centre (NICC) and Belfast City Hospital (BCH). Potential participants will be identified at the regional Uro-Oncology Multi-disciplinary Team (MDT) Meeting by oncology and urology consultants. Eligible patients who present for their diagnosis/treatment decision appointment will be informed of the study by their consultant and with their permission, details passed to the research team. Potential participants will be sent an information pack including a participant information sheet and consent form, and written informed consent will be obtained prior to participation. Process consent will be used throughout the study.
Age-matched non-cancer men
The matched non-cancer men will be recruited using peer-nomination [17]; each participant that opts for AS will be asked to nominate a male family member or friend who meets appropriate inclusion and exclusion criteria. 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 [18, 19]. Should a participant be unable or unwilling to nominate someone, potential participants will be approached in the university and via researchers’ social circle who will then be matched to the AS patient as closely as possible in terms of their demographic profile [19].
Upon nomination of a suitable peer, the researcher will contact those nominated via telephone pending the permission of the potential non-cancer participant. Potential non-cancer participants will be sent an invitation pack which will include consent forms, information sheet and stamped addressed envelope for the return of consent form and questionnaire.
Phase 1—Quantitative
Outcome measures
Demographic information will include: age; marital status; relationship status; sexual orientation; education level; employment status; ethnicity; co-morbidities (physical or psychological); other major life events in addition to the PCa diagnosis, sexual activity and personality as measured by the Eysenck Personality Questionnaire (EPQ) [20]. To assess psychological and physical functioning, the Centre for Epidemiologic Studies Depression Scale (CES-D) [21]; State-Trait Anxiety Inventory (STAI-6) [11]; Memorial Anxiety Scale for Prostate Cancer (MAX-PC) [22]; Mishel Uncertainty in Illness Scale—Community version (MUIS-C) [23]; Decisional Regret Scale [24]; EuroQol (EQ-5D-5 L) [25] and a modified version of the Expanded Prostate Cancer Index Composite (EPIC) [26] will be used.
A number of the scales to be used in the proposed study (EPQ, STAI-6, CES-D, MAX-PC) are based on a previous AS study conducted in the Netherlands [14] and therefore are deemed to be suitable for use in the target population. In addition we will assess prostate specific function (EPIC), general quality of life (EQ-5D-5 L), illness uncertainty (MUIS-C) and decisional regret (DRS). With the exception of the Decisional Conflict Scale (DCS), the scales used in the Dutch study have reported acceptable psychometric properties [13, 14, 21, 27, 28] and have been used in both prostate cancer populations and the general population previously [14, 15]. The additional scales included in the present study have also demonstrated adequate psychometric properties in the target populations [24, 29–35].
Prostate cancer patients (AS and AT)
At baseline, (when participants have not yet decided on their treatment approach), demographic information, depression (CES-D), anxiety (STAI-6 and MAX-PC), prostate symptoms (EPIC) and general physical health (EQ-5D-5 L) will be assessed. Three months post-commencement of treatment/AS, patients will be asked to complete CES-D, STAI-6, MAX-PC, MUIS-C, Decisional Regret Scale, EPIC, EQ-5D-5 L, items assessing PCa knowledge and involvement of the physician in decision making. The same combination of questionnaires will be completed in 3-month intervals for up to 12 months with the exception of the involvement of the physician in decision making, pending continued process consent (see Fig. 1).
To detect potential selection bias, patients who opt not to participate and those who choose to drop out of follow-up will be asked to complete a one-item anxiety Likert scale (“Please indicate the number that shows how anxious you feel at the moment.”) [36]. This one-item scale was chosen due to its high correlation with the STAI-6 and other anxiety scales [37].
Age-matched non-cancer men
As can be seen in Fig. 1, non-cancer participants will be assessed in 3 month intervals up to 12 months, coinciding with their corresponding AS patient’s follow-up time, using CES-D, STAI-6, EPIC and EQ-5D-5 L. At initial assessment, i.e. T3 months, participants will also be asked to report demographic information and complete both the EPQ and PCa knowledge questionnaire. Selection bias will also be assessed using the one-item anxiety scale [36].
Phase 2—Qualitative
Following completion of Phase 1, 10–15 of those AS participants who have reported both the best and worst psychological functioning will be invited to participate in face-to-face in-depth semi-structured qualitative interviews (Fig. 1). Although participants will have provided written consent at study inception, potential Phase 2 participants will be informed of what is involved in the interviews, given an opportunity to ask questions/discuss any concerns and will be made aware of their right to refuse participation or withdraw at any point without providing an explanation.
The purpose of Phase 2 is to further explore the quantitative results of Phase 1, to gain a richer understanding of participants own interpretation of their illness and its impact on their psychological wellbeing [38], be it positive or negative. A recent systematic literature review conducted by the research team, along with the outcome of Phase 1, will be used to frame topics for the semi-structured interviews [10], however participants will also be encouraged to discuss issues that they feel are of importance to them. Transcripts of each interview will be audio recorded, and transcribed verbatim.
Participants will be asked to suggest an interview location where they feel most comfortable which may include their own homes or the designated research room in the cancer centres. Interviews are expected to last for approximately 60 min however this is dependent on the participants’ willingness to talk and the depth they wish to discuss the topics.
Although interviews will consist of a semi-structured format, with a range of predetermined topics, participants will be encouraged to discuss issues of personal importance that the quantitative phase or the phase 2 topic guide may not have addressed. Participants will be given the opportunity to articulate their own personal and unique experiences of PCa and AS. Participants will be viewed as ‘experiential experts’ while exploring their interpretations of their experiences of prostate cancer and active surveillance. Verbal and non-verbal observations will be recorded immediately post-interview in a field diary to document subtleties that may not be picked up via audio recorder e.g. mood, emotion, body language. This field diary will be used to aid data interpretation and analysis [39].
Participants may struggle to discuss issues, such as sexual symptoms or psychological distress, with the researcher. To overcome this, the researcher will place emphasis on developing rapport with the participant, assuming an open and non-judgemental approach and ensuring the participant is aware of the strict confidence within which their information will be kept. Previous research has shown that men with prostate cancer embrace the opportunity to discuss personal issues in a confidential research setting outside of their immediate social circle and medical team, and are willing to provide rich data on the topic [40].