Patient perceptions and preferences about prostate fiducial markers and ultrasound motion monitoring procedures in radiation therapy treatment
Abstract
Introduction
Patient experiences and preferences of image-guidance procedures in prostate cancer radiotherapy are largely unknown. This study explored experiences and preferences of patients undergoing both fiducial marker (FM) insertion and Clarity ultrasound (US) procedures.
Methods
A sequential explanatory mixed method approach was used. A questionnaire (n = 40) ranked experiences from 0 to 10 (worst) in the domains of invasiveness; pain; physical discomfort; and psychological discomfort. Responses were analysed with descriptive and inferential statistics. Semi-structured interviews (n = 22) obtained further insights into their perspectives and preferences and were thematically analysed.
Results
Perceptions of invasiveness varied with 46% reporting FMs more invasive than US and 49% the same for the two procedures. The mean score for FM was 3.6 and 2.1 for US. Mean scores for pain, physical and psychological discomfort were higher for FMs with 3.3, 3.2 and 2.9, respectively, and 1.1, 1.2 and 1.7 respectively for US, only pain achieved significance (P < 0.05). Three themes emerged from the interviews: Expectations versus Experience; Preferences linked to Priorities; and Motivations. Eleven patients (50%) preferred US; however, 10 (45%) could not illicit a preference.
Conclusion
Participants found both of the FM and US image-guidance procedures tolerable and acceptable. Men’s preference was elusive, suggesting a more rigorous preference methodology is required to understand preferences in this population.
Introduction
Gaining perspectives from patients is important in healthcare provision and research and is gaining traction in the radiation oncology setting.1-3 Rapid technological advancements in radiation oncology present an opportunity to gain patient perspective into different techniques and technologies to complement the clinical and technical data, particularly those with equipoise. For example, options for monitoring prostate motion during external beam radiation therapy treatment delivery include gold seed fiducial markers, Calypso beacons and Clarity ultrasound. However, a paucity of literature exists regarding patient perspectives on these technologies.
Gold seed fiducial markers (FMs) are commonly utilised in prostate radiotherapy to accurately locate the prostate on daily imaging. FMs are surgically implanted using transrectal ultrasound guidance, and patients are not routinely sedated for the insertion.4, 5 Three electromagnetic beacons are inserted into the prostate for Calypso technology using the same technique as FMs.6
In contrast, Clarity involves the placement of an external ultrasound probe against the patient’s perineum every day for the duration of treatment delivery.7 While non-invasive, the placement of the probe requires treating staff to ensure the patients’ scrotum is out of the way and applying some pressure to gain a clear ultrasound image.8 Thus, the procedure may be considered ‘personally invasive’.
This study aimed to explore patient perceptions of the surgical procedure for FM insertion compared to the daily placement of the ultrasound probe using Clarity. Patients were asked for their preference of the two procedures. Additionally, we aimed to explore the factors patients considered when choosing between different technologies and procedures.
Methods
This sequential explanatory mixed methods study was completed as a subset of a larger randomised control trial [ACTRN12617001102369]. The study was approved through Townsville Hospital and Health Service HREC (HREC/17/QTHS/9) and James Cook University HREC (H6970), and all patients provided written informed consent. Patients were eligible if they had both FMs and Clarity ultrasound image-guidance performed during the study period.
Participants firstly completed a ‘Procedures Experience’ questionnaire. This questionnaire was developed by the investigators and included both open and closed questions, covering physical and psychological experiences. Closed questions used a 10-point Likert-type scale to assess patient perceptions of pain and invasiveness of both the FM insertion procedure and the Clarity procedure. Participants were provided with the questionnaire on the day of FM insertion and Clarity simulation. Five patients piloted the questionnaire to assess for comprehensibility prior to data collection which were not included in final analysis.
Semi-structured interviews were also conducted, with the aim of qualitatively exploring the patient’s procedural experiences and preference. Purposive sampling was used to ensure a breadth of demographics, experiences and views based on the questionnaire responses. Interviews took place between the day of insertion and the first week of treatment to limit recall bias. It was, however, ascertained in the interviews that the participants understood that Clarity was a daily application as part of their treatment. The interviews were conducted by one investigator (AB), with the use of an interview guide. The interviewer was a clinician, but not directly involved in the treatment of participants.
The interviews were performed in-person or by telephone (by choice of participant), recorded and transcribed verbatim. Participants could choose to have a support person present for the interview.
Data and Analysis
Descriptive statistics and Fisher’s exact test were used to analyse the questionnaire responses in R statistical software Version 3.6.1.9
The transcripts, interview recording and researcher notes were entered into NVivo (QSR) version 12 for analysis. The first five interviews were coded independently by two investigators (AB and TP), with the code list compared and ratified. Reflexive thematic analysis was performed, with both deductive and inductive coding.10, 11 The remainder of interviews were coded by one investigator (AB). Interviews and analysis were performed concurrently to maintain focus and develop analytical depth and integration of the data. Interviews were conducted until pragmatic saturation was reached.12 To confirm trustworthiness, the findings were discussed with and reviewed by a third team member not involved in data collection and analysis (RP).13 Excerpts of the transcripts are provided in the following results section to exemplify the identified themes, with all identifying information removed.
Setting
This study was conducted at a regional tertiary hospital and health service in Australia. The radiation oncology department services a large geographical catchment area, and patients may travel up to 800 kilometres from rural and remote regions for radiation therapy treatment. At our centre, both male and female health professionals perform the FM insertion and the Clarity set-up.
Results
Demographics
The demographics of participants in both the questionnaire (n = 40) and the interview (n = 22) are summarised in Table 1.
| Questionnaire | Interview | |
|---|---|---|
| Number of participants* | 40 | 22 |
| Mean age in years (range) | 73 (60 to 85) | 72 (62 to 84) |
| Staging | ||
| T1c | 4 (10.0%) | 2 (9.1%) |
| T2a | 3 (7.5%) | 2 (9.1%) |
| T2b | 9 (22.5%) | 7 (31.8%) |
| T2c | 12 (30.0%) | 7 (31.8%) |
| T3a | 10 (25.0%) | 4 (18.2%) |
| T3b | 1 (2.5%) | 0 |
| T3c | 1 (2.5%) | 0 |
| Androgen deprivation therapy | ||
| Yes | 35 (87.5%) | 21 (95.5%) |
| No | 5 (12.5%) | 1 (4.5%) |
| Number of biopsies | ||
| 1 | 32 | 16 |
| 2 | 5 | 5 |
| 4 | 1 | 1 |
- * Each participant had undergone both fiducial insertion and Clarity procedures at time of questionnaire and interview.
Questionnaire
A summary of the questionnaire results is presented in Table 2. The only domain which was statistically different between the two procedures was the pain median score (3 for FMs, 0 for Clarity). Perception of invasiveness varied with 46% reporting FMs more invasive than US and 49% considered the two procedures equivalent.
| Fiducial markers (n = 40) | Clarity (n= 40) | |
|---|---|---|
| Physical discomfort | 3 (0–8) | 1 (0–6) |
| Psychological Discomfort | 3 (0–9) | 1 (0–8) |
| Pain* | 3 (0–8) | 0 (0–8) |
| Invasiveness | 3 (0–10) | 1 (0–10) |
| Information (count) | ||
| Not informed | 1 (2.5%) | 0 |
| Somewhat | 0 | 3 (7.5%) |
| Well Informed | 37 (92.5%) | 34 (85.0%) |
| Not recorded | 2 (5.0%) | 3 (7.5%) |
- * Indicates statistically significant difference (P < 0.05).
Interviews
The interviews ranged from 10 to 54 minutes (mean of 27) in length. The majority (18) were performed in person, with six choosing to have someone present (wife/partner = 4; daughter = 1; and sister = 1). An additional three participants were invited to interview, however, two did not wish to proceed, and one could not commit to several times suggested.
Analysis of the interviews revealed three major themes: Expectations Versus Experience; Preferences linked to Priorities; and Motivations (Table 3).
| Major theme | Subthemes |
|---|---|
| Expectations versus experience |
Expectation based on past experiences Physical experiences Psychological experiences |
| Motivations |
Desire to cure cancer Acceptance Resolve Resignation |
| Preferences linked to priorities |
Doctor knows best Reasoning Understanding and Information |
Expectations Versus Experience
I’d had two biopsies before so I reckon they were worse. It would be different if I didn’t have them first. It was better than the biopsies. (P32)
There was probably a little bit of pain [with insertion] … But nothing, you know, nothing you couldn't put up with sort of thing. (P03)
All I felt there was when they pushed it [the Clarity probe] up it touched me, you know, pushed up. And when they got it in position, they just left it. Pretty sure I didn't even know it was there. (P01).
The only other thing with the treatment, I’ve solved this myself actually, you’ve got so much gel down there right? Now when you stand up, to go and get changed, it runs down between your legs. So, I go to the toilet now and clean myself off. (P32)
I was very apprehensive at first. I sort of had a rough idea of what to expect, because when they inserted the seeds, I had previously had a biopsy done, so I was assured that the biopsy was more painful than planting the seeds. I was still apprehensive. (P19)
I firmly believe that you leave your pride at the door and pick it up on your way out. So, I had no hassles. (P09)
Maybe some blokes would be embarrassed, things like that. You are lying on the table, getting the gold seeds in, you are naked sort of thing, and there are a lot of folk about you. (P20)
There’s no embarrassment. It’s got to be done. I’m […] lucky that they are doing it, that I can get it done, you know? (P18)
Motivations (Including Acceptance, Resolve or Resignation)
Then you have to set your mind to it – ok, I’m going to beat this thing. Use a lot of mind over matter. (P12)
You know you are sick; you know you have to get it cured. […] Aiming for a cure, so you take the best option, and to me, that is the best option at present. (P10)
I wasn’t happy, well, it’s got to be done, it’s got to be done. […] Yeah, leave to the professionals, and just do what you’ve got to do. (P22)
But you just accept this, if you want to get this treatment, and get over this cancer. That's the way I look at it. It's just one of those things. (P05)
My attitude is, I’m not going to die of it, I’m going to die with it, maybe, and when the treatment is finished, hopefully I’m going to be free and clear. […] Once treatment is finished, I am going to live life to the fullest. I’ve got a second chance. (P14)
I must admit it was a bit of a surprise… I had a stroke 5 years ago, so I'm thinking, why are all of these things rearing their head now, just as I'm retiring now, sort of thing. (P07)
Preferences linked to Priorities
With the motivation of actively seeking treatment and a cure for the prostate cancer, many men discussed their priority was to be cured. This then influenced perceptions and preferences for image guidance.
When asked to identify a preference, 11 participants preferred Clarity, one preferred FMs, and the remainder could not define a preference, even when presented with a vignette of describing the procedures to a friend and identifying their preferred procedure in the process. In those who could not define a preference, three said that they were ambivalent with both procedures, while seven indicated confusion about the need for both procedures, that is ‘Gold seeds and the Clarity Probe. They are tied up together aren’t they?’ (P20) and ‘I thought they were both to do with the whole procedure’. (P03).
I think it just comes down to perception really. I don't think that any guy likes to be laid down and have things inserted in them. […] It's just if… you've got some thoughts about invasive procedures, as a lot of guys do, then go for the Clarity. But if you're quite happy to go for the gold seeds, well… do it! (P06)
The internal thing is just not pleasant. (P17)
I did a navigation course years ago and to pinpoint your exact position on the earth, you had to have… to be more accurate, you had to have 3 … sightings of something and then you can pinpoint. And that's why I think that gold seeding is really accurate. (P03)
Main thing is to listen to those who are actually treating you, like the staff, and the doctor. (P19)
Too much information is too much problem… it's a problem for some people. And not enough is another problem for other people. So, you have to pick that balance. (P05)
And because it doesn't matter how much you read, you've still gotta go through with it. (P04)
Discussion
Overall, low scores across the questionnaire domains (physical discomfort, psychological discomfort, pain and invasiveness) were supported by the ‘gotta do’ attitude in the interviews. There was a statistically significant difference in the median pain score of the FMs and the Clarity procedures; however, it is noted that both procedures scored low overall. The low scores indicated the resolve of this patient population to treat and ‘beat’ the cancer. Robins et al (2018) similarly found low pain scores reported by patients who had undergone transrectal ultrasound-guided biopsies, with an overall median pain score of 3 (0-9).14 The main themes emerging from interviews illustrated the variety of ways the men faced and processed their prostate cancer treatment.
Results from the questionnaire showed no statistically significant difference in physical discomfort between the procedures. However, during interviews, most men only reported FM discomfort, with little mention of Clarity discomfort. Pang et al reported that patients found the Clarity positioning was acceptable.15 However, this was a cohort of patients who only experienced the Clarity set-up, with no other literature on the patient perspective of FMs and Clarity.
Reports of lack of embarrassment was at odds with clinical staff anecdotal observations of many patients expressing a fair degree of both verbal and non-verbal embarrassment during the FM procedure. Low embarrassment levels were also evident in the questionnaire’s psychological discomfort score. It is possible that embarrassment is acutely felt at the time of the FM procedure, but quickly forgotten or brushed aside by the men, particularly with the pragmatic approach of getting the procedures ‘over and done with’ to achieve cure. Chapple et al (2007) reported similar findings of downplaying of pain, discomfort and embarrassment in their qualitative study of patient experiences of prostate biopsies, a procedure similar to FMs.16 Similarly, the participants accepted any embarrassment associated with the Clarity procedure in the pursuit of cure, although the reports of this embarrassment were low in both the questionnaires and interviews. Future studies in this population may benefit from data collection closer to the procedure to validate whether there is acute embarrassment, or incorporating field observations into future studies.
Seemingly negative (Resignation) and positive (Resolve) mindsets were presented during interviews. Both mindsets led to the same outcome in this group of participants – the active pursuit of treatment with the desire to cure the cancer. The notion of proactivity in curing cancer was also identified in Saigal et al as an important attribute in prostate cancer treatment where undergoing treatment validated a proactive approach.17
The stoicism expressed by many participants is in keeping with hegemonic masculinity, reported in the broader male population and the prostate cancer-specific population.18-20 Kannan et al described the ‘Australian masculinity’ stereotype of stoicism, silent endurance and a reluctance for help-seeking behaviour.19 Stoicism was also reflected in the overall low scores of the questionnaire domains. A number of strategies employed by prostate cancer patients have been identified in the literature, including positive mindsets, using humour to diffuse the emotional situation and believing the cancer was non-invasive and non-aggressive.21
The desire to beat the cancer was reported by most interviewees as their priority. To this end, they were willing to be guided to the most appropriate treatment choices recommended by their treating team of health professionals. This finding is consistent with Smith et al demonstrating trust in the radiation oncology professionals was such that that patients would agree with their treatment recommendations without much questioning.22 Likewise, Scherr et al also found urology professionals opinions influenced prostate cancer patients treatment decisions.23 Literature about prostate cancer preferences is currently focussed on prostate cancer screening and treatment modality decision-making, rather than specificities of a treatment modality such as image-guidance.24-27
The inability of many participants to separate the two procedures may have influenced the viewpoints expressed. In particular, the 7 participants who could not give a preference could not do so because they could not separate the two procedures in the interview. As participants received both procedures, asking them to hypothetically choose one over the other departed from their lived experience making the choice difficult. Indeed, many participants were surprised to be asked, suggesting patients are unfamiliar with health professionals asking them about their health preferences.
Of note, most participants indicated they were well informed about both procedures. However, this was not evident in the interviews where many could not separate the necessity of the two procedures suggesting the educational information about the reasoning of the two procedures was not understood or retained by participants, or indeed may not have been adequately given by the health professionals. Disparate information needs of participants were noted with some wanting to know everything, while others were satisfied to know only the basics. This dichotomy of information needs was also found by Kannan et al amongst undiagnosed men.19 It is recognised that understanding the patient’s health literacy level, their preference for both information and treatment decision-making should not be overlooked by the healthcare community.28-30
Strengths and Limitations
This study was able to gain perspectives from patients who had undergone two image-guidance procedures. Our centre was in the unique position of using both procedures in routine care at the time of the study, giving the opportunity to directly compare both, which strengthens this study.
As the interviewer was a younger female, the male participants may have been reticent when discussing their prostate cancer experiences and preferences. To limit this influence and put them at ease as much as possible, the participants could choose to have a support person present. This may reflect the low reporting of embarrassment in interview, compared with clinical observations. Another limitation is ethnic homogeneity, with all participants of Caucasian decent.
Future Directions
With a large proportion of participants (45%) unable to initially identify a preference at interview, a discrete choice experiment (DCE) will be undertaken. This qualitative work will inform the DCE development. The importance of patient perspectives in health technology assessments is recognised, and this body of work will contribute to the assessment of the Clarity system.
Conclusion
Overall, both image-guidance procedures were well tolerated by patients, with low rates of pain, discomfort and embarrassment reported. Interviews revealed the majority were willing to follow the clinician’s recommendations regardless of their own personal preference, with a large percentage (45%) not able to express a personal preference.
These results could potentially be extrapolated to insertion of other markers such as electromagnetic beacons done in the same procedure as FMs. For radiation oncology departments considering the implementation of either of these two procedures, these results will be reassuring that patients find both of the image-guidance procedures tolerable and patient reflections could be considered along with the clinical and technical data.
Acknowledgements
This work was supported by the Townsville Hospital and Health Service Study, Education and Research Trust Account [2017_02]. The authors thank the participants who gave their time and offered their insights. The valuable contributions and guidance of Dr Alex Tan, A/Prof Emily Callander and A/Prof Kerrianne Watt to the larger study protocol development is gratefully acknowledged. Amy is grateful for the ongoing support of the James Cook University Doctoral Cohort program, and colleagues of the Townsville Cancer Centre.
