A Mixed Methods Investigation of Unmet Needs And Psychological Wellbeing During Active Surveillance For Prostate Cancer


 Purpose: While prostate cancer survivors experience unmet supportive care needs (USCNs) after definitive treatments, no study has measured USCNs during active surveillance (AS). This mixed-methods study aimed to identify and explore the USCNs and psychological wellbeing of AS patients.Methods: Patients 18+ years diagnosed with prostate cancer, who had been on AS for ≥6 months, were invited to complete a survey measuring USCNs, general and prostate cancer specific anxiety, and depression. A purposefully selected subset was also interviewed to explore USCNs and how needs during AS were addressed. Semi-structured interviews were transcribed verbatim and thematically analysed. Results: One hundred and three participants (n=47 currently on AS, n=54 on/had subsequent treatment, n=2 ceased all care) completed the survey, and 33 were also interviewed. Although most USCNs were considered low/moderate, 20% of participants reported high unmet informational needs around receiving information about monitoring and their test results. USCNs related to patient care (e.g., access to services in rural areas or after hours) and sexuality were also discussed in interviews. Anxiety, depression, and prostate cancer specific anxiety were generally very low. Fear of cancer progression/recurrence was the highest scoring prostate cancer specific worry and was frequently mentioned by interview participants.Conclusions: While unmet needs, anxiety and depression were generally low, one in five patients during AS experience unmet needs in psychological, physical, patient care, information, and sexual domains. Health professionals should be aware of common USCNs and offer appropriate support to address potential needs.


Background
Active surveillance (AS) is the recommended treatment option for people with low risk prostate cancer [1]. It involves routine surveillance of biological markers of the disease through the use of prostate speci c antigen (PSA) testing, digital rectal examinations, biopsies, and magnetic-resonance imaging (MRI) [1].
Transition to treatment is recommended upon identi cation of disease progression that constitutes reclassi cation [2]. Despite these recommendations and increased use of AS worldwide [2], there is no global consensus for AS initiation criteria, best practice for surveillance/follow-up, or triggers for intervention. As such, uptake and protocols vary greatly across clinics and countries [3][4][5]. This lack of consistency and consensus for best practice may impact patient's experiences, needs, and adherence during AS.
Approximately 12% of patients who begin AS will discontinue without evidence of disease progression, for largely unknown reasons [6], though factors such as anxiety, fearing mortality, and pressure from family/friends may contribute [4,7]. Approximately 4-17% and 6-8% of patients on AS report generalised anxiety and depression, which is similar to rates among those who have de nitive treatment [8-10].
However, much of this research has been conducted on samples recruited from cancer centres which specialise in AS management. Research which has recruited from a wider population has indicated that patients on AS consistently report high scores on anxiety and depression measures, which may actually increase over time [11]. Fear of progression may be a particular concern, as it is commonly reported in patients on AS [12][13][14][15] and is higher in patients on AS than in those who have undergone de nitive treatment [16]. Persistent fear of progression during AS and ongoing anxiety may lead patients to discontinue AS prematurely to receive de nitive treatments in an attempt to gain control of their health and disease [11].
Unmet supportive care needs may also contribute to discontinuation of AS, either directly or indirectly by negatively impacting psychological wellbeing [17][18][19]. A recent systematic review [20] suggests that patients on AS may experience a variety of unmet needs, most commonly related to inadequate and/or inconsistent information. However, only eight studies ( ve qualitative and three cross-sectional) were included in the review and the cross-sectional studies did not assess USCNs using a validated measure [20], such as the Supportive Care Needs Survey [21]. Just three of the studies had a primary aim of identifying unmet supportive care needs in patients on AS. Therefore, USCNs experienced by patients on AS, and their magnitude, are largely unknown, as is the extent of and ways in which unmet needs in uence discontinuation of AS.
Understanding patient's experiences and needs during AS is essential for targeting support, to inform future research on issues faced by AS patients, and potentially improve compliance to AS management when appropriate.

Aims
This mixed methods study aimed to measure and explore the USCNs and psychological wellbeing of patients currently or who had previously been on AS after a prostate cancer diagnosis. A mixed methods approach to this study was considered important given the limited research to date and to allow potential identi cation of unmet needs not included in validated measures. Additionally, it may help us explore the methods patients have utilised to address unmet needs and which of these methods patients felt were successful.

Sample
Participants were recruited as part of a larger case-control study designed to examine social-ecological factors associated with discontinuing AS [22]. The larger study, in which we had intended to recruit from multiple states in Australia, was paused due to COVID-19. Quantitative data collection from South Australia was completed prior to COVID-19. As such, this sub-study includes cross-sectional data from the South Australian participants.
Eligible participants were identi ed and recruited through the South Australian Prostate Cancer Clinical Outcomes Collaborative (SA-PCCOC), which captures 90% of all diagnosed prostate cancer survivors in the state [23]. All eligible cases (individuals who had left AS and received de nitive treatment without evidence of signi cant disease progression), and four matched controls (individuals still on active surveillance or who had received de nitive treatment following adverse risk reappraisal, as clinically recommended) were invited to participate in the study (N=270) based on a sample size calculation for the main study.
Eligibility criteria for the survey were: diagnosed with prostate cancer between January 2014 and October 2019, commenced AS after diagnosis, on AS for at least six months (could still be on AS or since received further treatment), 18+ years old. Patients were deemed ineligible if insu cient registry data was available to determine their treatment(s). Participants who completed the survey and provided their contact information on the consent form were considered for interviews and were selected using purposeful sampling [24]. Predetermined selection criteria were based on responses to the survey in regard to anxiety, depression, prostate speci c anxiety, USCNs, rural/regional location, and reasons for or considering AS discontinuation (see supplementary material). Ability to participate in a telephone interview in English was also required.

Procedure
Ethics approval was obtained from Southern Adelaide Local Health Network (HREC/19/SAC/88).

Survey
They survey could be completed on paper, online, or via phone. Following eligibility screening, two pilot tests on the survey were conducted. The rst assessed survey readability. Feedback was provided by four prostate cancer patients and two health professionals and adjustments to the survey were made accordingly. The second pilot test assessed response rate in a random sub-sample (n=32) prior to the main mail-out. Six completed surveys (18.8%) were returned. Given this low rate, changes were made in line with established methods for increasing response rates (i.e., use of a priming letter and unconditional monetary incentive) [25]. The remaining eligible participants (n=238) were mailed the priming letter and one week later, the survey package (containing information sheet, consent form, survey, reply-paid envelope, and unconditional incentive). If no response was received after two weeks, a reminder letter was mailed. Participant demographics, clinical data, and treatment information were retrieved from SA-PCCOC.

Interviews
Interviews were semi-structured and aimed to explore experiences on AS, USCNs, and psychological wellbeing (anxiety and depression) during AS (see supplementary material for interview guide). Participants were interviewed via phone, and interviews were audio recorded and transcribed verbatim.
Interviews lasted on average 31 minutes (range 15-63 minutes). We invited all participants who met sampling criteria; as per Braun and Clarke's recommendations [26], thematic saturation was not considered the primary aim of recruitment.

Outcome measures
Validated measures (see Table 1) were used to assess USCNs, general and prostate cancer-speci c anxiety, and depression. Demographic information was also assessed using standard items. Additional measures were included in the survey to assess potential predictors of adherence to AS (e.g., physical activity, coping strategies) and will be reported elsewhere. were re-analysed by MM to ensure all data was considered. Themes were then created, revised, and formally de ned. Finally, themes were summarised with quotes from the transcripts, and re ned by all authors.

Participants
One hundred and three participants returned a completed survey (38% response rate). Of these, fortyseven were currently on AS, and fty-four had received further treatment. Two participants indicated they had ceased all treatment and follow-up care. Most participants were married (83%), retired (64%), had completed post-secondary education (70%), and lived in a major city (71%; Table 2).

Unmet supportive care needs
An overview of the USCNs by domain is presented in Table 3. Moderate-high unmet needs were most common in the Health System and Information domain (e.g., being given written information about care, being informed of treatment side effects, informed of tests and monitoring results, provision of information and support from hospital staff), and Sexuality domains (e.g., changes in sexual feelings, relationships, and receiving sexual health information). Over one-fth of participants (21.6%) reported moderate-high unmet needs regarding fear of the cancer spreading (Psychological domain). Very few participants reported moderate-high unmet needs in the Physical and Daily Living and the Patient Care and Support domains. A complete summary of needs is presented in Table 4.  Prostate cancer 0.6 (0.6) Most were married (82%), retired (61%), completed post-secondary education (79%), and lived in a major city (64%), see Table 2. Nine (27%) participants lived in an outer regional or remote area, four (12%) met clinical thresholds for anxiety and/or depression, ve (15%) reported experiencing prostate-speci c anxiety (in at least one of the subscales), and 13 (39%) reported a moderate-high unmet need in at least one domain.

Overview of themes
Participants generally reported minimal USCNs and anxiety regarding their prostate cancer. Three overarching themes were identi ed. The rst, "Unmet needs on AS", explores the unmet needs discussed by participants, and includes four sub-themes of speci c unmet needs identi ed. The second theme, "How needs were addressed during AS", details the methods participants used to address needs and why they did not feel they experienced unmet needs after their cancer diagnosis. The nal theme, "Hindsight is 20/20", explores the perspectives of participants who had since received de nitive treatments on their unmet needs during AS. Illustrative quotes relevant to each theme/subtheme are presented in Table 5. • "And I think I raised it with a GP, but my GPs at that time were ladies and whether they were reluctant to do anything to take that up, or whether they just didn't think it was very important. That has become more of a signi cant issue for me in more recent years. I have to say, but having said that, my wife has very severe back pain. And is, you know, there really wouldn't be much opportunity for that side of life anyway." Participant 13235, De nitive Treatment/s Patient Care and Support Needs • "Maybe a little bit more time, perhaps with the actual urologist maybe would be good or, or one that speaks, and I don't mean this badly, but one who's perhaps a little bit more GP orientated, a little bit better bedside manner, rather than just the medical side of things." Participant 14695, Active Surveillance • "Oh yeah. That was really bad. And then if they want to do anything for country people, it would be to organise biopsies to be done in regional, country hospitals because it's not rocket science really." Participant 9107, Active Surveillance Psychological Needs and Anxiety • "Then the worry comes at the time that the numbers you know, when you keep going back to your PSA tests, and to see the results, you're hoping like hell, the numbers are gonna work out to be right, you know?" Participant 16058, De nitive treatment/s • "Um, I won't say anxiety, but the uncertainty was annoying. And this goes back to this grey area I keep talking about. Beside that, just that uncertainty… you couldn't get the degree of facts-based support that I would have been, you know, that I'm entirely comfortable with. So that causes some anxiety." Participant 15132, De nitive Treatment/s How needs were addressed during AS Unmet needs of patients during AS • "Mostly I relied on the discussions with the doctor himself, or herself… The communication between them provided everything I needed really. Basically, it was, there was nothing that I wasn't unclear about that, or had concerns about, or any needs that were unmet." Participant 13959, De nitive Treatment/s • "Pretty private dude. And I have my connections, friends and family who are, in in the systems and medical business side. It wasn't like I was out here by myself trying to work out what to do next. I had pretty good information. I didn't feel the need for anything other than my family support" Participant 9107, Active Surveillance • "It's very important thing, it's a lot of worry off your mind… one thing I didn't have to worry about was funding for all that, all the, the treatment. You know, for either biopsy or the proctectomy, and the follow up treatments, all those things. All that was funded by DVA. So I was very, very fortunate that that happened. Additionally, several participants expressed uncertainty about their understanding of test procedures (e.g., biopsy and PSA), their safety and e cacy, and their effect on their overall health.
Another participant described the lack of understanding of AS and prostate cancer treatment options in his (ethnic minority) culture. This participant explained needing to keep his diagnosis and treatment private due to the stigma associated with cancer in his culture and community. The participant reported a need for increased information dissemination about AS and prostate cancer to minority communities in Australia and overseas.

Physical and sexuality needs
Participants regularly mentioned that a physical di culty, such as erectile dysfunction and urinary incontinence, was the rst symptom investigated that led to their prostate cancer diagnosis. Most participants had spoken to their urologist and/or general practitioner (GP) regarding these issues, and whilst some experienced improvements, for others they continued throughout AS.

Patient care and support needs
A more holistic form of healthcare (addressing full-body health) within AS follow-up appointments was desired by several participants. Participants wanted care to address ongoing physical symptoms (such as incontinence or erectile dysfunction), and to check for other health issues in blood tests, not just PSA levels. These participants expressed wanting a doctor who was compassionate and considered their whole health, rather than just their prostate cancer.
Most rural participants felt their experience and needs during AS were not signi cantly affected by their location. However, many acknowledged that long-distance travel could be di cult due to urinary incontinence or pain after a biopsy. Several participants also mentioned that AS would be easier if they could have biopsies and MRIs in hospitals closer to home. Furthermore, accessing support services was reported as more di cult when living rurally, due to con dentiality concerns, work schedules, or distance.

Psychological needs and anxiety
Whilst most participants reported experiencing very little or no anxiety in regard to their cancer, some felt anxious or worried before their appointments while waiting for test results. Participants described worrying that their cancer had progressed and would require treatment, or in some cases, that the cancer had metastasised and it was too late for treatment.
Several participants described feeling uncertain about staying on AS due to the inability of doctors to predict outcomes. Participants expressed a desire to receive objective recommendations and information speci c to their diagnosis and expected future outcomes. Sometimes this uncertainty and unclear future left participants feeling anxious and worried.

How needs were addressed during AS
Information and support regarding prostate cancer and AS provided by the primary prostate cancer doctor was regularly described as su cient for the patient's needs. Many reported they did not feel the need to access additional support from practitioners such as psychologists, dietitians, or prostate cancer nurses. Participants often con rmed they would be comfortable asking for referrals for additional support if they desired it.
Many participants reported seeking additional information via "Dr. Google", research papers, prostate cancer-related programs on television, textbooks, and prostate cancer or cancer websites (e.g., Cancer Council). Others found it bene cial to speak to other prostate cancer survivors or friends who were also medical professionals to discuss their experiences, seek support, or ask questions, particularly regarding de nitive treatments.
Several men in the study had been members of the Australian Defence Force and held a Department of Veteran Affairs (DVA) healthcare card, providing them with nancial support for cancer treatment, among other healthcare bene ts [28]. Participants explained that holding a DVA card improved their experience and reduced their USCNs as it enabled them to access cancer treatment and other support services for free or at a discounted rate.
Many of the participants in the study reported experiencing very little to no anxiety or unmet psychological needs regarding their cancer, the AS protocol, or the future during AS. Participants attributed their comfortability and lack of anxiety/depression to having trust and a good relationship with their doctor, having adequate access to information and support, and because they experienced minimal or no physical AS symptoms. Maintaining a positive outlook and objectivity was also considered to aid in reduced anxiety and worry.

Hindsight is 20/20
For participants no longer on AS, re ecting on their unmet needs during AS helped them identify areas which they, in hindsight, thought would have helped to improve their AS experience. This was especially the case for psychological support -several participants had begun seeing a psychologist after undergoing de nitive treatment and wished they had done so sooner. Similarly, some participants felt they may have had fewer unmet needs post-de nitive treatment if they had accessed health professionals, such as a dietician, prostate cancer nurse, exercise physiologist, or physiotherapist, whilst on AS.

Discussion
Despite research demonstrating that 80% of patients experience USCNs after de nitive prostate cancer treatments [29], and over 35% experience at least one USCN 15 years post-diagnosis [30], no research has used validated measures to explore and identify the USCNs of patients on AS. Given the unique management style AS provides to patients diagnosed with low risk, localised prostate cancer (which is the most common prostate cancer diagnosis [31]), understanding the needs of these patients is imperative for providing them with adequate care, support, and information. This is the rst study to identify and measure the USCNs of patients on AS using a validated measure and a mixed-methods design. Within our sample, USCNs were reported across all domains, with moderate-high needs most commonly in informational, sexual, and patient care needs. However, average unmet needs per domain were re ective of low-moderate levels. In addition, our sample reported low levels of anxiety (general and prostate cancer-speci c) and depression. Ways in which healthcare practitioners might address the USCNs mentioned by participants are summarised in Table 6. Just over 20% of the sample reported moderate-high unmet needs in at least one item across information, sexuality, psychological, and patient care domains. Unmet informational needs were the most common; participants reported a desire for written information about AS care, treatment options and side effects, and receiving test results and explanations for these results. Similar unmet informational needs are often reported by prostate cancer patients after de nitive treatments [29,32], and were the most common reported need in a systematic review on USCNs in patients on AS [20]. Several unique unmet informational needs were identi ed in our qualitative analysis. Unmet needs related to the desire for information speci c to the role and functioning of the prostate and the ways in which it is affected by prostate cancer treatments and tests was mentioned by one participant. Another participant discussed unmet informational needs regarding the awareness of prostate cancer (i.e., treatment options including AS and de nitive treatments) in his minority ethnicity community. In line with recent recommendations for practitioners working with prostate cancer survivors [33], these unmet informational needs may be addressed through an increased focus on disseminating information on men's health and prostate cancer to primary care providers, community workers, and prostate cancer survivors and their families, especially those living in rural/remote areas and people from culturally and linguistically diverse (CALD) backgrounds. Ensuring messaging is consistent, readily available, evidence-based, culturally appropriate, and takes into account existing health literacy and preferences for information is essential for reducing unmet informational needs [33].
Sexuality needs were the second most common moderate-high USCN by patients in the present study.
Information on addressing sexual function and intimacy issues is a common unmet need for patients post-de nitive treatment, given that erectile dysfunction is a common side effect of most prostate cancer treatments [19]. The present study has identi ed that, like patients after de nitive prostate cancer treatment, patients on AS may also require information and support regarding their sexuality and sexual function. Similar again to USCNs seen after de nitive treatments [29,32], physical unmet needs relating to urinary incontinence were also reported by participants on AS. Health practitioners with patients on AS must ensure they provide information and support and routinely check-in with patients to identify if additional support or information regarding sexuality or physical function is required.
Finally, although generalised and prostate cancer-speci c anxiety scores were generally low across participants, over 20% of participants reported fear of cancer progression as an unmet psychological need while on AS. Feelings of fear, worry, and uncertainty were also regularly discussed by participants in interviews. Participants described feeling concerned and fearful of the cancer spreading too quickly, negating their ability to cure the cancer with de nitive treatments. Previous research has demonstrated that fear of progression and anxiety, whilst generally low and similar to levels reported by patients after de nitive treatment, are experienced by patients on AS [8, 34, 35]. Psychological unmet needs and fear of progression may be combatted by reducing unmet informational needs (e.g., providing clear and consistent information about AS, test results, treatment options, and triggers for de nitive treatment) and routinely discussing psychological wellbeing and providing referrals to psychological or other services when applicable. This is especially vital given that several participants in the present study reported di culties in accessing support services due to their rural location or work schedules. Furthermore, many participants in the study who had since received de nitive prostate cancer treatment shared that in retrospect, additional psychological support, access to a prostate cancer nurse, or referrals to a dietician or exercise physiologist may have been bene cial during AS to improve their experience and anxiety/fears.

Limitations and future research
Several limitations should be considered when interpreting these results. The original case-control study (which intended to recruit from multiple Australian states) was unable to proceed due to COVID-19 shutdowns. Consequently, our sample size was considerably lower than originally planned and prevented us from statistically investigating predictors of higher USCNs. Further research with larger samples is therefore required to understand the extent of USCNs in patients on AS both in Australia and worldwide.
With no global AS protocol and wide variations in healthcare services and systems, research is also to determine whether unmet needs differ by location. While our ndings suggest that patients from culturally and linguistically backgrounds may experience unique USCNs after prostate cancer diagnosis, as we only recruited participants who could communicate uently in English, these results are limited, and further investigation is needed.

Conclusions
This cross-sectional mixed-methods study is the rst to measure and explore the USCNs experienced by patients during AS using a validated measure and interviews. While unmet needs, anxiety and depression were generally low, one in ve patients during AS experience unmet needs in psychological, physical, patient care, information, and sexual domains. To reduce unmet needs, including anxiety and fears of cancer progression, and potentially prevent AS discontinuation prematurely, it is essential that health professionals provide consistent and clear information, and enquire about their patient's needs and psychological wellbeing regularly.

Declarations
Funding: This study was funded by a Below the Belt research grant through the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). Author MM was supported by an Australian Government Research Stipend during her PhD and received further support from well as the Freemasons Centre for Male Health and Wellbeing.
Con icts of Interests: The authors declare there are no relevant nancial or non-nancial interests to disclose.