3.            Introduction 

The number of PC survivors in the United States has approached 2.9 million with approximately 164,690 patients expected to be diagnosed in 2018 alone [1]. For patients diagnosed with localized disease (Gleason score 6 or less, cT1/T2a, prostate specific antigen less than 10 ng/ml), cancer care options include definitive treatment (e.g, prostatectomy) and Active Surveillance (AS) [2,3]. However, recent randomized-controlled trials in PC patients have showed a significant amount of overtreatment leading to a potentially avoidable decrease in Health-Related Quality of Life (HRQOL) [3]. AS delays definitive treatment until it is warranted on the basis of defined clinical indicators of disease progression [4]. Ideally, an AS protocol involves: a) identification of low-risk patients; b) rigorous monitoring for PC progression and c) providing appropriate therapy to those whose disease has progressed [5]. While the impact of AS on patients’ HRQOL is less deleterious than for those who pursue definitive treatment, men on AS also experience substantial anxiety and distress [6,7]. Very few studies have examined barriers and facilitators of uptake of AS from the patient and provider perspectives [8,9]. These studies showed that patient factors affecting decisions about AS include younger age at diagnosis, higher educational level, desire for cancer control and cure, and avoidance of treatment side effects [2,8,9]. A national survey among 1,366 physicians showed that although the majority believe that AS is effective, only a minority would recommend it for eligible patients [10]. The present study aims to identify factors that influence patients’ decisions and adherence to AS from both the patient and the provider perspectives with the goal to inform supportive care of patients and their family caregivers (e.g, psychosocial, educational, and communication interventions) [2,10]. 

4.            Study Design 

4.1.              Selection and Recruitment of Participants

We used purposive sampling method [11] to recruit PC patients from the Icahn School of Medicine at Mount Sinai (ISMMS) between January and May 2016. Patients were eligible if they were 1) on AS protocol, able to communicate in English, and 2) between 18 and 85 years of age. Exclusion criteria included other cancer, metastasis, or cancer recurrence. This was done to reduce potential recall biases introduced by experiencing unmet informational needs unrelated to the AS experience. Patient data was collected though patient interviews, and via patient Electronic Health Records (EHR). Three ISMMS PC health care providers were interviewed to increase understanding of the challenges, barriers, and potential facilitators for the uptake of AS from their perspectives. This study was approved by the ISMMS Institutional Review Board. 

4.2.              Procedures

Eligible patients identified through EHR were sent invitation letters to participate in the study. Guided by literature reviews, our prior studies, and input from the research team [12,13], a semi-structured interview guide was developed to explore 3 major areas: 1) patients’ needs at time of diagnosis, 2) patients’ needs while on the AS protocol, and 3) patients’ recommendations for health care improvements and follow-up care (Appendix A in Supplementary material). Of the 60 patients approached, 32 (53%) agreed to participate, and 28 (47%) completed an interview on phone (n=17) or in person (n = 11). The median time for the interviews was 60 minutes (range: 30–90 min). Consent forms were obtained prior to each interview. Reasons for non-participation or inability to complete the study included lack of interest or time and a poor health condition. The patient interviews were conducted by the same member of the research team (NM). Providers were asked by a second member of the research team (TB) about challenges patients have with AS and suggested strategies to enhance patients’ decisions and adherence to AS (Appendix B in Supplementary material). All interviews were audio-taped and transcribed. Coding was conducted simultaneously with data collection and data collection ceased on reaching data saturation (i.e, when no new or relevant data emerged regarding the information/support needs categories) [14-16]. We used the Rapid Assessment Approach (RAA), to timely develop an understanding of AS patient experience and factors influencing adherence to AS. The RAA is an intensive qualitative inquiry using data triangulation [14] via conducting interviews, iterative qualitative data analysis via deductive coding, and utility of patient HER [14]. The utility of phone interviewing allowed inclusion of patients unable to participate in person due to geographical, medical or work-related restrictions to take part the study based on their time preferences. Alleviating these restrictions allowed us to increase the demographic (i.e, currently employed younger patients), and geographic heterogeneity of the study sample [17]. 

4.3.              Data Analyses

Content analysis of participant responses included checking for representativeness of the data (i.e, checking interpretations against raw data), data triangulation (i.e, use of both interviews [14] and confirmation of clinical data using EHR ), with an emphasis on contextually thick description (e.g, incorporating non-verbal responses and participants’ emotional state) [15,16,18]. Patient recruitment continued until we reached data saturation with 28 patients (i.e, when adding more participants to the study did not result in additional codes of themes) [19]. Digitally recorded interviews of patients and health care providers were structured based on two interview guides; one for patients and one for stakeholders Following the RAA guidelines, two members of the research team (HC and JH) used the interview guides while listening to each recording to create case summaries capturing patients’ and providers’ responses to main codes or domains of interest [16,20-23]. Summary accuracy was facilitated by verifying details from recordings and identifying rich segments for in-depth analysis. Summary points were then transferred to a matrix display to systematically identify response trends. Differences in interpretations and summary points were resolved through entire research team discussions until all discrepancies were resolved. 

5.            Results 

The majority of patients (N = 28; age range: 54-73 years) were married (78.6%), Caucasians (75%), and self-identified as heterosexual 89.3%; (Table 1). 

11 patients participated in in person interviews and 17 patients participated in phone interviews. Although the majority were low risk (89.3%) based on D'Amico criteria [24], 3 patients were intermediate risk (10.7%). A physician, a physician assistant, and a nurse practitioner participated in the stakeholder interviews. The summary points that emerged from the data analyses are listed in (Tables 2-6). 

5.1.              Factors that Influenced Patients’ Decisions about AS: Patient Perspective

39% of the patients reported unmet informational needs at time of diagnosis. These needs revolved around understanding AS; follow-up tests and frequency of testing; and side effects of frequent biopsies. 89% searched the internet, talked to other PC patients on AS, or read medical journals about AS. The information searched included comparing AS to PC definitive treatments, potential changes in sexual function, and AS selection criteria. Over three quarters (79%) of participants followed the physician’s recommendation for AS. Trust in the physician’s expertise and good intentions, spouses’ participation in the decision making, spouses’ age, and the desire to avoid sexual dysfunction associated with other PC treatments strongly influenced patients’ decisions. All but one reported feeling stressed about the possibility of PC progression and more than two-thirds (68%) felt that the major challenge with AS is losing the chance for a definitive treatment in the future. 

5.2.              Challenges Encountered During the AS protocol: Patient Perspective

Patients expressed no desire to discontinue AS or regret for their decisions. Patients, however, stated that felt more stressed around the time of repeat prostate specific antigen testing and prostate biopsies. Insufficient information about follow-up care and care management plans as well as missed or delayed follow-up appointments also contributed to patients’ stress levels. Moreover, financial and insurance barriers were reported as reasons for potential AS discontinuation in the future. 

5.3.              Factors that Could Enhance Patients’ Decisions About and Adherence to AS: Patient and Provider Perspective

Patients’ and providers’ input revealed several strategies that could enhance patient decision and facilitate adherence to AS. Patients’ suggestions included using different informational tools (e.g, brochures, Websites, patient portals) presented in different languages and formats; sending reminders to patients of follow-up appointments; and improving access to programs to help patients with lifestyle changes (e.g, physical activities, and dietary changes). Providers’ suggestions included matching patients with other survivors who are currently on AS based on patient demographic characteristics (e.g, age, race) and sexual orientation; improving the utility of mental health and social support resources within the health system and in the community to enhance patients’ self-regulation and control beliefs; increasing family caregivers’ involvement in PC treatment decision-making and follow-up care; and providing caregivers with access to the patient’s clinical test results and care plans (e.g, patient-and-caregiver portals). 

6.            Discussion 

Despite the uncertainty associated with AS, this management option remains a viable option for men with early stage, localized disease. Examining patient and provider factors that influence patients’ decisions about AS and their adherence to a life-long surveillance protocol are crucial steps in improving shared treatment decision making and follow-up care. However, data on factors that may hinder or increase the uptake of AS in eligible patients is limited. We have conducted personal interviews with PC patients on AS and their health care providers to identify salient issues and significant challenges associated with treatment decision making and adherence to AS protocols. In general, our study results mirror research findings in unmet informational needs among other cancer populations including AS patients (e.g, information on cancer prognosis, information on AS, information on alternative management options, lifestyle modification, access to support resources and interaction with other survivors, and financial and medical system information) [24-26]. Providers’ input confirmed unmet needs reported by AS patients and described several areas for care enhancement (e.g, utility of follow-up care plans, shared treatment decision and educational tools, and support resources). 

Our study results indicated that although the majority of patients followed their physician’s recommendation, they were dissatisfied with the information they received about AS and the follow-up protocol. Because patient engagement in AS decisions and follow-up care is imperative given the intensive follow-up surveillance plans and the uncertainty associated with AS outcomes, patients need to be fully informed about all aspects related to AS compared to other PC management options. There is evidence that informed PC patients are likely to make treatment decisions that reflect their values and preferences, adhere to treatment regimen, and experience improved outcomes (e.g, HRQOL, satisfaction) [27,28]. However, a major challenge for physicians that could influence their treatment recommendation and communication with patients about AS is the absence of a standardized criteria identifying patients best suited for this option. Due to the ambiguity of AS protocols, clinicians are often uncomfortable with the lack of a universal protocol and do not have a strict understanding of which patients are best a fit for AS. 

In our current work, we have categorized patient input according to 3 major areas: 1) unmet informational needs at time of diagnosis and during treatment decision making, 2) unmet needs during the AS protocol, and 3) patient input on strategies to facilitate both patients’ decisions and adherence to AS protocol. Several critical issues came to light, which, if addressed, could enhance patients’ experience and engagement in their health care. These issues include the need for full information about AS compared to other PC management options, the need for information about risk for PC progression while on AS protocol, and increased stress and worries specifically around the time of follow-up screening test. Patients and care providers in our study suggested several care enhancement strategies that could reduce the difficulties experienced by patients in treatment decision making and challenges experienced during follow-up care. These suggestions include greater involvement of family and caregivers in PC management and treatment, communication with physicians about PC management options; utilization of a variety of informational materials on AS (e.g, brochures, websites, patient portals presented in different languages); and follow-up reminders using phone calls, Emails, or text message. Prior research in cancer patients showed that the utility of similar tools and reminders has increased patients’ satisfaction with care, adherence to cancer screening, and reduced decisional regret [29-31]. Thus, it is likely that these tools, if implemented in AS standard care, may improve patient outcomes and reduce physicians’ burden of care. 

Additionally, both patients and care providers in our study suggested improving supportive care resources and programs to help patients with their emotional adjustment and lifestyle changes (e.g, physical activities, diet and nutrition, participating in support groups). The descriptive information of our sample showed that half of the study sample had other disease or health conditions for whom interventions and support may improve management of both PC and of other conditions comorbid with PC. Increasing evidence from recent cancer research points to the significant positive impact of lifestyle changes and social support on survival, cancer progression, and patient-centered reported outcomes (e.g, HRQOL, stress, fatigue) [32,33]. Engaging patients in positive lifestyle changes is likely to increase their control and self-efficacy beliefs, which will, in turn, boost their coping and emotional adjustment [34,35]. This is particularly relevant in circumstances where there is uncertainty regarding cancer progression and patient outcomes. Involvement of informal caregivers, particularly spouses and intimate partners, in treatment decision-making and follow-up care emerged as a significant theme confirming other research findings [36,37] Spouses and intimate partners play a significant role in cancer treatment decision making, adherence to follow-up recommendations, and provision of emotional, financial, and instrumental support [38]. A previous study in PC patients and their partners showed that decisions for AS were built on couples’ evaluation of the man's health condition, desire to avoid side effects (e.g, sexual dysfunction), and trust in the ability and accuracy of the AS protocol in identifying negative changes for a successful definitive treatment whereas couples’ decision for surgery was motivated by their desire to remove the cancer at all costs [39]. Thus, understanding the spouse/partner’s attitudes, beliefs, and expectations about AS is needed to facilitate dyadic (patient-spouse/partner) and triadic (patient-physician-spouse/partner) AS decision-making and adherence to AS. Furthermore, because of their caregiving roles and involvement in AS decision making, family caregivers could benefit from strategies that maximize their provision of support while reducing their stress levels and burden of care. Such strategies may include education about AS, increasing their participation in medical consultations, and utilization of medical supportive care services including access to patient’s lab results and care plans. The goal of these strategies is to help caregivers assume more active roles in patient disease management and reduce the emotional impact of both PC and patient care on their physical and emotional well-beings. 

7.            Limitations and Recommendations 

Our study has several limitations. Patients were recruited from a single institution. The majority of our study population was Caucasian; well-educated, married/with partners, and heterosexual. Thus, our sample is unlikely to reflect the general characteristics of all prostate cancer patients. In order to maximize participation rate and to minimize recall biases, we used purposive sampling and targeted PC survivors currently participating in AS. As a result, there was an absence of data with patients who discontinued AS based on personal preferences and without evidence for clinical cancer progression. Future research should explore the challenges and unmet needs of these patients to further shed light on their beliefs and concerns that led to their decisions to discontinue AS. It is apparent from patient reports that family caregivers significantly influenced the patients’ decisions. Therefore, evidence of information and support needs obtained from caregivers will further enhance our understanding of both patient and caregiver factors that affect shared treatment decision making, dyadic communication, and patients’ disease management. 

8.            Conclusions 

Meeting patients’ and their family caregivers’ informational needs is imperative to ensure their adequate involvement in PC management, and to enhance their emotional coping and adjustment to cancer. The relative paucity of research in this population and their caregivers strongly suggests the need for research to further improve understanding of factors that affect patients’ decision making and adherence to AS protocol. Such research should take into account the patient’s background and the involvement of family caregivers in decision-making processes and disease management.

Table 2: Factors that affect patients’ decisions about PC management at time of diagnosis.

Table 3: Factors that affect patients’ adherence to active surveillance protocol.

Table 4: Patients’ recommendations for health care improvements and follow-up care.

Table 5: Challenges in PC management and patient care: Provider perspective.

Table 6: Summary of the patients’ prominent challenges in decisions and adherence to AS.

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