Introduction

Breast cancer is the most common type of cancer worldwide and the leading cause of death among women [1,2]. According to GLOBOCAN 2022, approximately 2.3 million new cases were diagnosed, with an age-standardized rate of 47.8 per 100 000 people [1]. In Uruguay, breast cancer is also a significant public health issue, ranking first in both incidence and mortality among women [3].

Over the past three decades, five-year survival has increased steadily, rising from 77% in 1989 to more than 91% in 2020, due to earlier detection and therapeutic advances, particularly in targeted and hormonal therapies [4,5]. This increase has highlighted the need to assess the impact of diagnosis and treatment on long-term health outcomes, particularly quality of life, persistent symptoms, and psychosocial well-being [5,6].

Interest in understanding the experience of cancer survivors has grown significantly, driven by the physical, emotional, and social challenges that persist after treatment. Beyond traditional clinical outcomes (such as recurrence, mortality, or physician-assessed toxicity), many symptoms and functional limitations go unnoticed, creating a gap between what patients perceive and what healthcare professionals record [7]. The incorporation of patient-reported outcome measures enables a more accurate assessment of the impact of cancer and its treatments on quality of life. In this context, instruments such as the Patient-Reported Outcomes Measurement Information System (PROMIS) Global or the Cancer Worry Scale have been shown to improve symptom detection, optimize interventions, and potentially influence survival [8].

Health-related quality of life is now a central goal in oncology, especially when clinical benefits are limited or the objective is palliative care [9]. According to the model proposed by Wilson and Cleary, health-related quality of life integrates biological, individual, and environmental factors that shape the overall perception of health [10]. Measuring it with validated instruments enables assessment of physical and emotional well-being, guidance of person-centered decisions, and detection of clinically relevant changes [11]. Furthermore, its role has expanded to include regulatory assessments and prognostic value, as its decline is associated with lower survival rates [12,13]. In breast cancer survivors, health-related quality of life can be affected by demographic and clinical factors. Young women with lower socioeconomic status or who are overweight tend to have a poorer health-related quality of life. Furthermore, certain treatments (such as mastectomy or axillary dissection) can leave lasting sequelae, including altered body image, anxiety, lymphedema, pain, and functional limitations [14,15,16].

Fear of cancer recurrence is one of the most common and persistent concerns in this group. It is also recognized as a key determinant of health-related quality of life. Between 18% and 56% of patients experience clinically significant fear of cancer recurrence [17,18]. This fear is associated with increased emotional stress (including anxiety and depression), as well as impaired social, occupational, and daily functioning [17]. Fear of cancer recurrence can exacerbate common symptoms such as fatigue, sleep disturbances, and reduced physical activity, all of which correlate with higher levels of worry [18,19]. Key risk factors include young age, perceived stress, intensive treatments, and avoidant coping strategies [17,18,19,20]. Furthermore, fear of cancer recurrence can persist for years after treatment, underscoring the need for its systematic screening and specific psychosocial interventions [18,20].

Despite the available evidence, some aspects remain insufficiently characterized. International studies show mixed results regarding the influence of sociodemographic variables (particularly age and educational level), with associations varying by cultural context. Many cohorts combine patients undergoing active treatment with disease-free survivors, making it difficult to isolate the impact of clinical characteristics and treatments once the therapeutic phase has ended. The persistence of fear and its association with quality of life in cohorts who have completed treatment has been rarely reported using standardized instruments such as PROMIS, and in Latin America—particularly in Uruguay—there is virtually no data on these phenomena. The objective of this study is to describe the prevalence of fear of recurrence, quality of life, and their association with clinical and sociodemographic variables in survivors of early-stage breast cancer. The hypothesis is that greater fear of recurrence is associated with poorer quality of life.

Methods

Study design and setting

A cross-sectional observational study conducted at two public referral centers in Uruguay: the Hospital de Clínicas (Montevideo) and the Hospital Departamental Zoilo A. Chelle (Soriano).

Participants

The study included patients over 18 years of age diagnosed with early-stage breast cancer (stages I–III) who had completed treatment with surgery, chemotherapy, and radiation therapy at least 12 months prior to enrollment and who had not experienced a relapse at the time of the study. Patients were recruited during outpatient follow-up at both centers and completed self-administered questionnaires at enrollment.

Variables and data sources

Sociodemographic and clinical variables were collected through self-administered questionnaires and a retrospective review of medical records. The primary variables (fear of recurrence and quality of life) were assessed using the instruments described below.

• Sociodemographic variables: age at the time of the study (under 50, 50 to 65, over 65 years), educational level (incomplete elementary/secondary school, completed secondary school, college/university), and time since diagnosis (2 years or less, 2 to 5 years, more than 5 years).

• Clinical and treatment variables: tumor stage at diagnosis (I, II, or III), type of breast surgery (segmental or total mastectomy), type of axillary surgery (axillary lymph node dissection or sentinel lymph node biopsy), and receipt of adjuvant treatments (chemotherapy, radiation therapy, and hormone therapy) as dichotomous variables (yes/no).

Health-related quality of life was measured using the PROMIS Global 10 questionnaire [20], which assesses physical and mental well-being through 10 items with Likert-scale responses. From these, two summary scores on the T-scale (global physical health and global mental health) and two individual items reported as raw scores (global health and daily functioning) are derived. T-scores are calibrated against the general U.S. population, with a mean of 50 and a standard deviation of 10. Values above 50 indicate better self-perceived health than the population average, and values below 50 reflect poorer health, with each 10-point difference equivalent to one standard deviation. Although PROMIS does not establish universal clinical cut-off points, T-scores below 40 are generally interpreted as moderate impairment, and those below 30 as severe impairment of self-perceived health. The Spanish (Latin American) version, administered by HealthMeasures and officially validated and standardized, was used [21].

Fear of recurrence was assessed using the Cancer Worry Scale [22], consisting of 6 items on a Likert scale (total score 6 to 24). Higher scores on this scale reflect greater fear. Scores were operationally classified into three levels: low (6 to 10), moderate (11 to 18), and high (19 to 24). The original version does not propose universal clinical cutoff points. The ranges used reflect predominantly low, intermediate, and high responses across the six items and allow for clinically interpretable stratification.

Additionally, communication between patients and the healthcare team regarding fear of recurrence was explored through ad hoc questions posed by the research team (the presence and reasons for the dialogue, responses received, changes in concern, and the type of support desired). The results are presented descriptively.

Sample size

The sample size corresponded to a fixed available sample, consisting of all patients who met the inclusion criteria during the recruitment period at both centers. No formal a priori sample size calculation was performed, given the descriptive nature of the study. The final cohort of 301 patients allows estimation of frequencies with 95% confidence intervals of approximately ± 5.7 percentage points for an expected proportion of 50% (maximum-variance scenario).

Statistics

Statistical analysis was performed using R software. Demographic and clinical characteristics, as well as health-related quality of life scores, were described using measures of central tendency and dispersion for continuous variables. Absolute and relative frequencies were used to describe categorical variables.

Associations between clinical and sociodemographic characteristics, as well as categories of fear of cancer recurrence, were assessed using the chi-square test. Comparisons of health-related quality of life between groups were performed using nonparametric tests (Kruskal–Wallis or Mann–Whitney, as appropriate).

A p-value < 0.05 was considered statistically significant. Results were reported with 95% confidence intervals.

Ethics

The study was conducted in accordance with the Declaration of Helsinki, the MERCOSUR Guidelines for Clinical Trials, and the research regulations approved by the National Ethics Commission. The protocol was reviewed and approved by the Research Ethics Committee of the Hospital de Clínicas under number 15-25. All participants provided informed consent, and data were handled confidentially in accordance with Law 18 331 on the Protection of Personal Data, ensuring their privacy at all stages of the study.

Results

A total of 301 patients with early-stage breast cancer were included. The median age was 65 years (range 22 to 93). 38.2% of the patients were between 50 and 65 years old, and 44.5% were over 65 years old.

The time since diagnosis was two years or longer in more than 80% of the cohort, with the majority having been diagnosed between 2 and 5 years prior. Most had completed high school.

Regarding clinical characteristics, 80% had stage I or II disease. The most common breast surgery was segmental mastectomy (65.4%), and slightly more than half required axillary lymph node dissection.

Regarding adjuvant treatments, 57.1% received chemotherapy and 85.4% received radiation therapy, while more than 90% had undergone or were undergoing hormone therapy (Table 1).

44.2% of the patients reported minimal fear of recurrence (95% confidence interval: 38.7 to 49.8). Moderate fear was observed in 20.9% (95% confidence interval: 16.7 to 25.9), while one-third of the cohort (34.9%; 95% confidence interval: 29.7 to 40.4) reported a high level of fear of recurrence.

In the bivariate analysis, fear of cancer recurrence showed significant associations with several clinical and sociodemographic variables. Patients who had been diagnosed 5 years or less ago and those under 50 years of age had a higher prevalence of moderate or high fear of cancer recurrence (p = 0.006 and p < 0.001, respectively). Educational level was also associated with fear of cancer recurrence (p < 0.001): women with only elementary or incomplete secondary education reported a higher frequency of minimal fear of cancer recurrence, while those with a complete secondary education had the highest levels. Chemotherapy (p < 0.001) and hormone therapy (p = 0.024) were associated with a higher proportion of moderate/high fear of cancer recurrence. No significant associations were observed between fear of recurrence and disease stage, type of breast surgery, axillary surgery, or radiation therapy (Table 2).

Nearly half of the patients did not discuss their fear of recurrence with their healthcare team. Among them, the most common reasons were not considering it a serious problem (46.1%), not knowing they could discuss it with their doctor (36.4%), and a lack of opportunity during the appointment (17.5%).

Regarding communication with the healthcare team, 38.2% of patients reported having brought up the topic during a visit, while 10.6% did so during more than one visit. On the other hand, 27.6% stated that they had not discussed it but would like to do so, and 23.6% felt it was unnecessary.

Among the patients who discussed the issue with a healthcare professional (n = 147), the most common responses included referral to another professional (23.8%), clear explanations of the risk of recurrence (35.4%), and reassuring emotional support (23.1%). 17.7% reported that the professional did not take their concern into account.

Regarding the need for coping strategies (n = 246), 44.7% indicated that they would not like to receive additional strategies and did not believe they needed them. However, 28.9% expressed that they would like to receive them.

Among patients who reported changes in their level of concern following the consultation (n = 80), 31.2% reported a significant decrease, while 61.2% reported no change.

Regarding the type of support they would like to receive (n = 301), the most frequently mentioned options were access to a support group (20.3%) and advice on managing anxiety related to recurrence (20.6%). A total of 36.5% reported not needing additional support (Table 3).

In the assessment of quality of life using the PROMIS scale, physical health had a median score of 37.4 (range 29.6 to 67.7), while mental health had a median score of 43.5 (range 28.4 to 67.6).

Regarding items interpreted as raw scores, overall health had a median of 3.0 (range: 2.0 to 5.0), and daily activities had a median of 3.0 (range: 2.0 to 5.0).

In the analysis of quality-of-life scores assessed using PROMIS (physical health, mental health, overall health, and daily activities), no significant differences were observed based on time since diagnosis, tumor stage, type of breast surgery, axillary surgery, chemotherapy, radiation therapy, or hormone therapy (all p > 0.05).

In contrast, age and educationa. l level were the only variables that showed significant associations across all PROMIS dimensions. Patients over 65 years of age had higher scores for physical health (p = 0.019), mental health (p = 0.008), overall health (p = 0.007), and daily functioning (p = 0.007). Likewise, patients with incomplete elementary or secondary education had the highest scores on these four dimensions, with significant differences by educational level (p < 0.001).

The complete results for each dimension are detailed in tables 4–7.

PROMIS scores by level of fear of recurrence

Patients with the highest fear of recurrence had significantly lower scores in physical health, mental health, overall health, and daily functioning, with a clear gradient between minimal, moderate, and high fear of cancer recurrence (p < 0.001 across all dimensions) (Table 8).

Discussion

Our results confirm that even in a cohort of disease-free survivors, fear of recurrence and quality of life remain critical areas that require systematic attention. The high prevalence of fear of cancer recurrence and its association with lower health-related quality of life scores highlight the importance of incorporating its assessment into clinical follow-up.

55.8% of patients reported moderate or high fear, a proportion consistent with international figures reporting between 45% and 59% of moderate/high fear among cancer patients and approximately 19% at clinically relevant levels [23]. In breast cancer, studies show rates of high fear of cancer recurrence ranging from 15 to 20% several years after diagnosis [17,19]. In Latin America, studies in Brazil report rates of 32% and 43% [24], with particularly high levels among young women and vulnerable groups, such as Latina women in the United States [25]. The factors most strongly associated with fear of cancer recurrence were time since diagnosis, age, and educational level. Patients who had been diagnosed 5 years or less previously reported significantly higher levels of fear of cancer recurrence than those diagnosed more than 5 years prior, a finding consistent with the available evidence. Longitudinal studies show that fear of cancer recurrence is most intense in the first few years after diagnosis and tends to decrease gradually, although up to 30% of survivors may continue to experience high levels of fear even 5 or 6 years later [26,27,28,29]. As has been described internationally, younger patients reported higher levels of fear of cancer recurrence, reinforcing the fact that age is one of the most consistent predictors of heightened concern about recurrence [29,30]. Although most studies report greater fear of cancer recurrence among patients with lower levels of education [27,29,30], in our cohort, women who had completed high school had the highest levels. This discrepancy may reflect local sociocultural differences, variations in risk perception, or differences in access to medical information.

Nearly half of the patients did not discuss their fear of cancer recurrence with their healthcare team, reflecting a widely described phenomenon: although between 13% and 38% of survivors report high levels of fear of cancer recurrence according to the Cancer Worry Scale (and up to 72% in cases of advanced cancer), many patients do not spontaneously raise this concern during their appointments [23,27]. International studies show that between 60 and 70% of those who experience fear of cancer recurrence wish to discuss the issue, but often do not do so due to lack of knowledge, lack of opportunity, or the perception that “it is not serious enough” [23,27]. This is consistent with our findings, in which the main reasons were not considering it a serious problem or not knowing it could be discussed with the doctor. Likewise, satisfaction with the healthcare provider’s response varies widely: while some patients appreciate receiving clear explanations or emotional support, others report that their concerns were not taken into account, which reflects the gaps previously described in the literature, especially regarding access to psychological support and specific strategies for managing fear of cancer recurrence [23,27].

The PROMIS scores in our cohort showed lower physical and mental health scores, a finding consistent with the literature, in which breast cancer survivors tend to have a lower quality of life than the general population, especially in the physical and emotional domains [31,32]. However, unlike previous studies that report a negative impact of cancer stage or treatments on health-related quality of life [32], no differences were observed in our population across clinical or therapeutic characteristics, suggesting a relatively homogeneous health-related quality of life once cancer treatment was completed. In contrast, age and educational level showed significant associations across all PROMIS domains. Indeed, women over 65 years of age and those with lower educational levels had higher scores, a pattern that may reflect differences in expectations, coping strategies, and perceptions of well-being—a phenomenon also described in other cohorts [32,33]. These results underscore the influence of sociodemographic factors on health-related quality of life and support the need for interventions tailored to age and educational level. PROMIS scores showed a progressive decline across all domains as fear of recurrence increased, a finding fully consistent with the literature. It is known that high fear of cancer recurrence negatively affects physical and mental health, social functioning, and the ability to resume daily activities, and may be clinically significant in 18–56% of breast cancer survivors [17,18,34]. Furthermore, fear of cancer recurrence is associated with increased anxiety, fatigue, and sleep disturbances—factors that contribute to an overall decline in health-related quality of life [18,19].

This study has several strengths, including a robust sample size and the use of internationally validated instruments (the Cancer Worry Scale and PROMIS), which allow us to compare our results with those of other populations. Furthermore, the inclusion of patients from two centers provides a representative view of real-world clinical practice. Furthermore, a descriptive analysis of communication between patients and the healthcare team regarding fear of recurrence was incorporated; this area has been poorly characterized in our context and provides preliminary information to guide future research and interventions.

Among the limitations, the cross-sectional design precludes establishing causality and does not allow assessment of changes in fear of cancer recurrence or quality of life over time. The use of self-administered questionnaires may introduce recall or social desirability bias, and voluntary participation could introduce selection bias. Furthermore, no details were collected regarding comorbidities or persistent symptoms that could influence PROMIS scores. Furthermore, although both instruments have Spanish versions previously used in other populations—PROMIS Global 10 via the universal Latin American translation administered by HealthMeasures, and the Cancer Worry Scale in a culturally adapted Spanish version—no formal assessment of semantic or conceptual equivalence was conducted in the Uruguayan population, nor is there specific validation available for our setting. This limitation should be taken into account when interpreting the scores obtained. Furthermore, aspects of communication between patients and the healthcare team were explored using ad hoc questions formulated by the research team rather than a validated instrument; therefore, the analysis is presented descriptively and should be interpreted as exploratory. Finally, given that the cohort comes from public healthcare centers, generalizations to other contexts should be interpreted with caution.

Conclusions

In this cohort of breast cancer survivors, fear of recurrence and quality of life remain central aspects of follow-up, even several years after diagnosis. The high prevalence of fear of cancer recurrence and its association with lower PROMIS scores highlight the importance of routinely assessing this issue. Furthermore, sociodemographic factors such as age and educational level significantly influenced both the fear of cancer recurrence and quality of life, reinforcing the need for personalized interventions. Our findings underscore the value of integrating psycho-oncological strategies and structured support into the routine care of breast cancer survivors.