Assessment of Patient Experience During Active Surveillance for Prostate Cancer

Abstract

Active surveillance is a preferred strategy for patients with low-risk prostate cancer to delay and/or avoid side effects of treatment. While its impact on health-related quality of life (HRQOL) has been studied, factors influencing follow-up adherence and patient involvement in active surveillance protocols remain less understood. This study aimed to explore patient perspectives on testing modalities, frequencies, and satisfaction with active surveillance. HRQOL surveys and active surveillance-specific questions assessed patients undergoing active surveillance at a US academic medical center between 2019 and 2021 after Institutional Review Board approval. Respondents were invited to interviews and thematic analysis identified key themes. Forty-six participants completed surveys and 12 were interviewed. Satisfaction with active surveillance was reported by 93.3%, and 97.7% indicated a willingness to opt for the same treatment again. Anxiety and urinary function were key factors influencing quality of life. Trust in the doctor's recommendations, avoiding side effects, and feeling it is a good way to monitor their cancer were common reasons for choosing active surveillance. Addressing organizational factors, treatment equity, and evolving patient perspectives can refine active surveillance protocols. Understanding patient experiences can inform tailored protocols and improve patient–provider communication, enhancing patients’ well-being and adherence.

Introduction

Prostate cancer (PCa) is the most commonly diagnosed and second leading cause of cancer-specific mortality among men in the United States. ¹ The prostate is a small gland that surrounds the urethra beneath the bladder, and treatment for prostate cancer with surgery or radiation can have significant urinary and sexual side effects that can affect quality of life (QOL). While certain cases display aggressive traits, many follow a slow-progressing trajectory. As a result, slower-progressing PCa often does not require immediate intervention such as radiation therapy or surgery (radical prostatectomy), both of which involve inherent risks of treatment-related side effects. This has led to controversy regarding the potential overtreatment of indolent cancers and a desire for management that can potentially avoid or delay side effects of treatment. Active surveillance (AS) has emerged as the preferred management strategy for low-risk PCa. AS is a pre-specified testing program to monitor patients for evidence of cancer progression which may warrant treatment aiming to defer radical intervention while preserving long-term disease-specific survival. ² Of note, men with indolent PCa managed with AS demonstrate comparable disease-specific mortality to those opting for curative therapy. ³

AS involves vigilant monitoring through periodic examinations, imaging, PSA (prostate-specific antigen) testing, and prostate biopsies. ³ The utilization of AS among low-risk PCa patients increased from 26.5% in 2014 to 59.6% in 2021. ⁴ However, despite this increase, adherence to follow-up testing consistent with established guidelines remains suboptimal, with fewer than one-third of patients receiving recommended assessments. ⁵ AS protocols have been developed using current evidence-based testing modalities rather than relying only on patient preferences, though the factors influencing guideline adherence remain unclear.

While validated questionnaires have been used to assess health-related quality of life (HRQOL) in AS patients,^6–8 factors influencing adherence to follow-up among PCa AS patients have not been thoroughly studied and patient input may be often overlooked in the development of AS protocols. This goal of this single-site study of low-risk PCa patients was to improve our understanding of their perspectives on undergoing AS for prostate cancer, including their view on testing modalities and frequencies, as well as their satisfaction with the decision to pursue AS, through the use of both surveys and interviews.

Methods

We used both surveys and semi-structured interviews of men with low-risk PCa to learn to investigate their perceptions regarding various facets of AS. The Institutional Review Board of Ohio State University approved all study materials prior to study initiation. All participants voluntarily consented to participate and provided written consent.

Study Participants

All male patients over the age of 18 diagnosed with prostate cancer at a single US academic medical center between 2019 and 2021 who met the criteria for low-risk PCa as described by the National Comprehensive Network^® (NCCN^®) were retrospectively identified using both ICD-9 and ICD-10 codes. These criteria included diagnosis of low-risk PCa with defined parameters encompassing biopsy results, PSA density, clinical stage, and Gleason score (≤6). ⁹ Additionally, patients were required to have documented AS as their chosen management strategy without opting for definitive treatment within the initial 12 months post-diagnosis; as a result, patients who underwent radical prostatectomy or radiotherapy during this time period were excluded. Once identified, patient records were manually reviewed to confirm their choice of AS as their preferred initial treatment.

Survey Data Collection

Upon identification, patients were invited to complete validated HRQOL surveys from the National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) toolkit. ¹⁰ Data collection was conducted between April 2021 and August 2021. The PROMIS Global Health v1.2 is a publicly available measure of patient-reported markers of physical, mental, and social well-being, and is supported by the NIH. ¹⁰ This scale was used to assess general mental health and physical health with higher scores indicating better HRQOL. The San Francisco-8b (SF-8b) is a short-form assessment of HRQOL that targets eight key domains: general health, physical functioning, role physical, bodily pain, vitality, social functioning, mental health, and role emotional. ¹¹ We also administered the Hospital Anxiety and Depression Scale (HADS), a self-assessment scale designed to detect states of anxiety and depression. ¹² The HADS is comprised of two components: HADS-A (anxiety) and HADS-D (depression). The total score for each subscale ranges from 0 to 21 with a score of ≥11 used to distinguish between cases of normal or moderate-to-severe levels of anxiety and depression. ¹² Questions were also administered asking about patients’ perspectives on AS and satisfaction with their treatment decisions. Survey respondents received a $10 gift card in appreciation for their time and participation. Data collection used the Research Electronic Data Capture platform, ensuring secure and streamlined procedures.^13,14

Survey Data Analysis

Descriptive statistics were computed utilizing median and interquartile range for continuous variables and frequencies for categorical variables using Microsoft Excel (Microsoft Corporation, Redmond, WA).

Interview Process

Upon completing the survey, respondents were invited to participate in a 30-minute in-person or telephone interview. The interview portion of this study was guided by a qualitative descriptive approach, which was well-suited for our aim of describing a phenomenon, namely patients’ perspectives about AS. ¹⁵ Interviews were conducted by trained qualitative interviewers utilizing a semi-structured interview guide that included questions about AS including about the AS monitoring protocols and about their care for PCa. All interviews were audio-recorded and transcribed verbatim. Interviewees received a $20 gift card in appreciation for their time and participation.

Interview Data Analysis

Interview transcripts were analyzed using deductive dominant thematic analysis. ¹⁶ This allowed for categorization of data based on pre-specified themes derived from the interview guide as well as identification of emergent themes. First, an initial codebook was developed based on the topics covered by questions in the interview guide. Two members of the research team coded a single transcript using the initial coding dictionary and then met to compare coding decisions, supervised by the lead qualitative investigator. Regular discussions among the coders informed refinement of and consistent application of the coding dictionary to the remaining transcripts. These weekly meetings enabled research team members to discuss concerns, discrepancies, and emergent themes as the coding proceeded. Using reflexive thematic analysis we compared themes across interviews to characterize perspectives about AS protocols. ¹⁷ We used ATLAS.ti 23.1.1 qualitative software (ATLAS.ti Scientific Software Development GmbH, Berlin, Germany) to support the coding and analysis process.

Results

Survey Study Participants

From a total of 214 patients undergoing AS who met the criteria for study inclusion, 46 participants consented and completed the initial survey item. Subsequently, 12 of these individuals agreed to be interviewed. Baseline characteristics of the study cohort are presented in Table 1. The median age at enrollment was 69 years. Patients were predominantly white (95.1%); retired (55.8%); married (79.1%); and insured (93.0%). Participants reported a median duration of PCa at the time of survey administration as 3.0 years [IQR 2.0, 4.0].

Table 1.

Demographic Characteristics and General Health-Related Quality of Life of Survey Participants (N = 46).

	N or Median [Range]	%	Missing N (%)
Age (years)
	69 [57-74]
Race
White	39	95.1%	5 (10.9%)
Black	2	4.9%
Highest level of education completed
High School	1	2.3%	3 (6.5%)
Vocational/Technical	1	2.3%
Some College	7	16.3%
College Graduate	13	30.2%
Postgraduate	21	48.8%
Employment status
Employed	19	44.2%	3 (6.5%)
Retired	24	55.8%
Marital status
Married	34	79.1%	3 (6.5%)
Living as married	1	2.3%
Divorced	6	14.0%
Single	2	4.7%
Household income
$20,000 - $34,999	1	2.5%	6 (13.0%)
$35,000 - $49,999	2	5.0%
$50,000 - $74,999	7	17.5%
$75,000 - $99,999	6	15.0%
$100,000 - $199,999	19	47.5%
$\ge$ $200,000	5	12.5%
Household size
1	6	14.0%	3 (6.5%)
2	29	67.4%
3 to 4	6	14.0%
4 to 5	2	4.7%
Insurance status
No	3	7.0%	3 (6.5%)
Yes	40	93.0%
Duration of prostate cancer (Years) [IQR]
	3.0 [2.0-4.0]

IQR = interquartile range.

Treatment Experience and Satisfaction

With respect to treatment, 91.3% and 58.6% of the cohort underwent PSA and DRE examinations within 12 months, respectively; 93.4% had undergone biopsy/magnetic resonance imaging (MRI) within 3 years. The majority of patients reported satisfaction with their treatment course (93.3%) and indicated a willingness to opt for the same treatment regimen again (97.7%; Supplemental Figure S1). Most participants also reported expressed satisfaction with the AS of various monitoring tests, including follow-up PSA testing (90.9%), rectal exams (70.7%), prostate biopsies (76.7%), and MRI scans (70.7%; Supplemental Figure S2a). Regarding suggested changes in the frequency and modality of monitoring tests, over half of the patients expressed a preference to maintain the current frequency for PSA tests (86.4%), rectal exams (83.7%), prostate biopsies (68.2%), and MRI scans (68.3%; Supplemental Figure S2b).

Health-Related Quality of Life

Based on the PROMIS Scale v1.2, self-reported measures showed a mean score of 3.7 for general health, 3.9 for general QOL, 3.7 for general physical health, and 4.0 for general mental health on a 5-point Likert scale, where 5 indicates excellent. Additionally, 63.04% of the cohort rated their QOL to be “very good” or “excellent” and 65.2% rated their satisfaction with social activities and relationships to be “very good” or “excellent.” The majority of the cohort reported experiencing “mild (37.0%)” or “moderated (30.4%)” fatigue on average. The average pain score was 2.5 (SD = 1.5), ranging from 1 to 6 out of 10 (Supplemental Figure S3). Results from the SF-8b showed patients experienced no significant limitations in daily, social, or physical activity (Supplemental Figure S4). In addition, 50.0% of the cohort reported “mild” to “moderate” pain based on this measure, and 64.9% of patients reported having “some” or “a little” energy, results which are aligned with findings based on the PROMIS Scale described above.

Depression and Anxiety

In the HADS survey, which assessed patient-reported depression and anxiety subscales, many participants did not feel “wound-up,” while 55.6% reported “sometimes” feeling slowed down. Additionally, 71.1% of the cohort reported they had “definitely” lost interest in their appearance (Supplemental Figure S5). Other metrics of depression and anxiety, such as worrying thought and sudden feeling of panic, were “very seldomly” or “not at all” experienced by a large portion of patients.

Urologic Symptoms

With respect to urinary frequency, 24.4% of patients reported experiencing it “quite a bit” and 6.7% “very much” during the day; 31.1% reported “quite a bit” at night; 26.7% reported increased urgency. All other measures of urological health including dysuria, use of urinary aid, fecal incontinence, hematochezia, edema, and limitations in activities were not frequently experienced by our cohort (Supplemental Figure S6).

Sexual Quality of Life

Nearly half (47.7%) of participants reported “quite a bit” of interest in sex, and a majority (54.6%) reported having engaged in sexual intercourse “a little.” Difficulty “getting/maintaining an erection,” was reported by 20.6%%, while 9.1% experienced issues with ejaculation, and 8.8% felt uncomfortable with sexual intimacy (Supplemental Figure S7).

Interview Study Participants

We interviewed 12 patients who had a median age of 69 years (range = 57-74 years).

Perspectives About Receiving Prostate Cancer Diagnosis

When describing feelings about receiving their prostate cancer diagnosis, patients reported a mix of emotions including both being shocked and “pretty much” expecting it. As one interviewee explained about the diagnosis, it was “Not too surprising. My, both my two brothers had prostate cancer as well and so with a high prostate specific antigen before that, I was kind of prepared for the shock so to speak and so forth.” During AS, their perspectives were similarly mixed, ranging from essentially ignoring the diagnosis to making one nervous. One participant reflected, “it’s not, I don’t, doesn’t keep me awake at night or anything like that. But I just think about that occasionally.” Additional representative comments from study participants are presented in Table 2.

Table 2.

Perspectives on Prostate Cancer Diagnoses.

Timing	Perspectives of Patients
At time of diagnosis	I really didn’t have any reaction in negative or positive. I pretty much expected it. It’s my understanding that your age is a percentage of chance that you have that, have cancer. So, I’m 72, I’ll be 73 this year. I figured it out sooner or later something’s going to pop up. I’ve had a father that had prostate cancer and an uncle that did. So, when I first received the diagnosis, it was at least a low-risk cancer so that was a relief in itself. Well, that, so yeah, I mean, certainly not good news. I’m a physician. So, I’m familiar with, you know, the disease process and so forth. But still kind of hits you like a ton of bricks, you know. And my brother had prostate cancer at age 58. So, I knew that it was a good chance that I was going to end up with it someday but still it, it kind of stuns you at first.
During Active Surveillance	I really don’t look at this that I have prostate cancer. And that’s I’m not ignoring that there is a problem but until I start really, until it starts affecting my lifestyle, I don’t have it. Well, I’ll be honest it makes you a little nervous because you wonder in like the months between your last visit to your next visit, okay, is this thing, has it started to become more aggressive and so forth? I’m comfortable with it right now, because I don’t have no indication that I have a major problem yet, or if I could get a major problem because you never know.

Perspectives About Choosing Active Surveillance

When asked about choosing AS for PCa, all interviewees described a process of informed decision-making that involved conversations with their doctor. As one participant explained, “Because when they did the biopsy, they did a very good job of explaining to me what the results really meant and truly meant. And, I felt comfortable and confident that that was the best way to go.” The most common reasons noted for choosing AS included: (a) trust in doctor's recommendation, (b) wanting to avoid side effects of treatments, and (c) feeling AS was a good way to keep track of their cancer. With respect to the first reason, trust, an interviewee reflected, “I trust him fully. I mean you know, again give our level of knowledge about prostate cancer, I don’t think I could do it any better. I have a lot of trust in what he’s saying.” Another interviewee summarized the second concern about side effects: “I looked at the surgery option and obviously there’s some big risks to that. It was the fear of impotence and/or incontinence.” The third common reason, a good way of keeping track of the cancer, was described by a participant: “I follow up with the doctor, on a regular basis on the recommended time frames to make sure that thing didn’t progress to the point where it would be a problem.” Additional example quotations about these reasons for choosing AS are included in Table 3.

Table 3.

Reasons for Choosing Active Surveillance.

Reason	Perspectives of Patients
Trust in doctor's recommendation	I already had a level of comfort with, with his diagnosis and, and his recommendation. So, you know, I didn’t think too far past it to be quite honest with you. Well, I was comfortable with the doctor, I trusted her. She was a professional and I was at [Institution]. I wasn’t at a just a local family doctor, I was up at, you know, the [Institution] Urology and I trusted. You know it’s a research hospital and I don’t know I was just comfortable with the doctor and where I was and said okay, you know you’re, you have the experience, and I trust you, so that’s what I base it on.
Desire to avoid potential side effects of treatments	Worried about incontinence. I guess after the fact, that more so than the removal of it, versus the radiology piece of it. At that point I was again still deep into doing athletic stuff and didn’t want to have to deal with that. I think the complications of surgery with like incontinence with it was the biggest thing that I was concerned about.
Feeling this is a good way to keep track of prostate cancer	It made sense to me that I mean if there was an active treatment, if there’s something that would be more active or aggressive treatment that I would need to deal with symptoms or deal with a more serious diagnosis, like the higher score, then I would have been interested in knowing more about it and digging into it and making a decision based on it but that kind of wait and see made sense for me. And if I was, I mean, if my, if I really had a lot of symptoms and my score was high, I would think about something that would be more, a treatment that was more aggressive.

Perspectives About Satisfaction With Active Surveillance

When asked about their experience with AS, a majority of interviewees described general satisfaction with AS, with individuals expressing confidence in the monitoring process and the prioritization of QOL. As one patient explained, “At this point, I’m not concerned with anything. I think the program is right on, but you never know with this disease I guess you could just pop up at any time, ravage your body at any time but you never know that. And you can’t go there daily obviously. So, I just, I think that the program and I have right now an active surveillance is spot on until something happens.” Another concurred, noting, “I like the name of it, you know, whoever, whoever coined that it makes a lot of sense it fits together. That look, you know, were we’re not forgetting about this, we’re going to stay active. But we’re just watching it and everything's going to be okay because we’re, you know, where they’re keeping an eye on it. So that's kind of comforting in itself, versus, just say, you know, I’ll see you next year.”

Discussion

AS for PCa requires active patient participation and engagement, therefore we sought to explore factors that might influence the HRQOL and participants’ experiences with AS. We found patients on AS were generally satisfied and reported minimal negative impacts on their HRQOL. However, many participants also experienced depression and anxiety, along with significant challenges related to urinary frequency, and low sexual QOL. We also learned that factors such as trust in their physicians, wanting to avoid side effects, and feeling AS could help keep track of their cancer were key reasons for choosing AS.

Patients in this study expressed general satisfaction with AS, particularly in terms of their trust in their provider and their perception that AS is an effective way to monitor disease progression. However, the satisfaction and positive impact of AS vary across different studies in the literature. Bellardita et al, aligning with our findings, found that patients on AS reported a good HRQOL and showed no significant psychological distress, with their overall HRQOL scores higher than those of patients undergoing post-radical treatment. ¹⁸ In contrast, Tan et al revealed that patients’ anxiety might be exacerbated by uncertainty, although the underlying causes of this anxiety were diverse. ¹⁹ While our findings align somewhat with previous literature, there is still limited understanding of both the positive and negative experiences associated with AS, particularly in terms of specific factors influencing its long-term efficacy and decisions to continue AS or select definitive treatment. The physical and psychological long-term effects of AS, such as the potential for ongoing physical symptoms and the emotional toll of uncertainty, remain underexplored. Therefore, further investigation is needed to better understand its long-term impact on both patients and healthcare providers.

A major concern among our participants was the impact of their disease on urinary symptoms and sexual health. The reported rates of urinary continence at 12 months following radical robotic or open prostatectomy range from 65% to 94%, and sexual function ranges from 57% to 97%, respectively.^20–24 In the context of AS, while AS serves to mitigate potential adverse QOL repercussions associated with curative treatments for PCa, a notable proportion of participants still reported symptoms such as urinary frequency and urgency. These symptoms may be attributable to heightened awareness of urinary issues subsequent to their cancer diagnosis. In addition, discrepancies were found between participants’ reported desire for sexual intimacy and their actual engagement, with erectile dysfunction frequently emerging as a concern. The impact of curative therapies on sexual function, such as following open prostatectomy, has been reported to range from 26.7% to 63%.^20–24 Although AS is considered to result in fewer sexual and urinary issues compared to curative treatments,^25–27 these concerns remain prevalent among patients with AS. According to guidelines from the American Urologic Association, clinicians are advised to counsel patients undergoing curative therapy about potential impacts on sexual and urinary QOL.^28,29 The reported risks of urinary incontinence and sexual dysfunction post-prostatectomy underscore the significant impact of surgical interventions on QOL parameters. Intriguingly, AS demonstrated comparable outcomes to external beam radiation therapy concerning sexual and urinary function. ³ Therefore, it is important to consider and address these symptoms and concerns when counseling patients about treatment options.

Patients undergoing AS for PCa often experience uncertainty and anxiety related to clinical symptoms associated with their condition. In our study, while participants were generally satisfied with AS approach, they still reported feelings of anxiety and uncertainty about their disease progression. Kim et al reported prostate cancer patients undergoing AS sought more information about AS approach and reassurance about future treatment options, including involvement in decision-making and addressing illness uncertainty and supportive care needs during follow-up. ³⁰ Tan et al also emphasized the importance of patient education, noting that managing lower urinary tract symptoms and using behavioral interventions may reduce anxiety related to uncertainty intolerance and support patient engagement in AS. ¹⁹ Developing specific education protocols to guide patients’ engagement in AS, with a focus on addressing concerns about urinary symptoms and sexual health, may help improve their experience. Testing these interventions could clarify their effectiveness in enhancing patient outcomes among PCa patients.

The use of AS in patients with low risk prostate cancer has increased dramatically in recent years, with a majority of patients choosing AS as their initial management strategy as of 2021, yet adherence to recommended surveillance recommendations remains low.^4,5,31 Qualitative studies on factors influencing AS adherence have shown that trust in surveillance as treatment, quality of life, patient experiences, involvement in shared decision making, the extent of supportive care and information, and support from partner and peers positively influenced adherence to recommended surveillance.^32,33 These finding, combined with ours, show opportunities to improve adherence to AS recommendations to potentially increase both patient satisfaction and improve outcomes.

Limitations

Our study has several limitations. First, our study took place at a single academic medical center, potentially limiting generalizability. In addition, selection bias may have influenced participation, with only patients successfully adhering to AS agreeing to participate. Furthermore, reliance on self-reported data introduces the potential for confounding and recall bias. The modest sample size further constrains the breadth of our findings, suggesting the importance of future studies that can include larger, more diverse cohorts. Finally, the absence of patients transitioning from AS to definitive treatment in this study warrants further investigation to elucidate factors influencing treatment discontinuation.

Conclusions

Patients in our study were reportedly generally satisfied with AS, which they viewed as a way to monitor their cancer and potentially postpone or avoid definitive treatment. By focusing on providing prostate cancer patients with the information they need about this treatment alternative, physicians can help foster trust in their relationships with patients, helping patients to make informed decisions that are aligned with their treatment goals.