Quality of Life and Psychological Distress in Advanced Cancer Patients: Associations with Sociodemographic and Clinical Factors

doi:10.21203/rs.3.rs-3132204/v1

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Quality of Life and Psychological Distress in Advanced Cancer Patients: Associations with Sociodemographic and Clinical Factors

https://doi.org/10.21203/rs.3.rs-3132204/v1

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Background

The study assessed quality of life, psychological distress, and their associations with socio-demographic and clinical factors in patients with advanced cancer before systemic treatment initiation.

Methods

The NEOetic-SEOM study, a cross-sectional, prospective, observational, and multicenter research, involved patients with advanced cancer confirmed through histology. We collected socio-demographic details, psychological distress (BSI-18), and quality of life (EORTC-QLQ-C30) data through questionnaires. Multivariate analysis was used to construct models, and forest plots were generated to represent the proportions of patients undergoing psychological and functional difficulties.

Results

The analysis included 507 patients (mean age 64.8 years, 54% male) with prevalent cancers being lung (29%), colorectal (16%), and pancreatic (11%). The majority underwent chemotherapy (79%) and targeted or immunotherapy (38%). 71% reported moderate/severe psychological distress correlating with functional (55%) and symptom problems (87%) (p = 0.001). Depression and anxiety rates were 71% and 63%. Males and good performance status patients showed higher functional scales, while older individuals, adenocarcinoma histology, and poor ECOG had increased symptoms. Lower education correlated with higher anxiety, depression, and psychological distress, mostly in younger patients. No associations were found between clinical variables (cancer stage or site) and quality of life or distress.

Conclusion

In summary, our investigation elucidates the distinct experiences of advanced cancer patients concerning sex, age, performance status, histological subtype, and education in relation to quality of life and psychological distress. These insights underscore the necessity for personalized therapeutic approaches to cater to the multifaceted requirements of patients with advanced malignancies.

Anxiety

BSI-18 scale

cancer

depression

EORTC-QLQ-C30

forest plot

Advanced cancer is a distressing experience that can negatively affect various aspects of a patient´s life. In 2020, there were approximately 20 million new cases of cancer, a number expected to increase by 47% in the next 20 years, particularly in developing countries [1]. Advanced cancer accounts for 10–15% of all cancer diagnoses, depending on tumor location (49.0% for lung, 24.9% for gastrointestinal, 6.3% for prostate and 2.6% for breast cancer). Currently, chemotherapy has been surpassed by targeted therapy in many cancers to practice precision medicine (e.g., melanoma, renal cancer). Research has shown that the presence of metastases is associated with higher levels of anxiety symptoms in most cancer locations [2, 3, 4].

Over 50% of patients with advanced cancer experience psychological distress [3]. The prevalence of depression and anxiety among these patients ranges from 20–72% and 20–80% respectively [3, 4, 5]. The variation in results among the studies may be attributed to methodological heterogeneity, sample sizes, patient, and cancer characteristics such as stage and probability of cure [3–7].

The importance of evaluating quality of life (QoL) in cancer care is increasingly gaining recognition, as it provides insight into the effects of cancer diagnosis, treatment, outcomes, and patient expectations throughout the cancer journey [2–7]. It is understood that cancer treatments can have a significant impact on an individual's QoL and, in turn, QoL impacts their tolerance, acceptance, and overall experience with the disease [5, 7]. Both the physical and mental condition of the cancer patient can also influence their QoL [8].

In recent years, there has been a growing interest in mental health and quality of life among cancer patients. However, there is a scarcity of research assessing the variables that modulate emotional distress and QoL in patients with incurable advanced cancer prior to initiating systemic treatment. Most published data focus on specific tumors, non-metastatic cancer with a more favorable prognosis, or patients in palliative care. This study seeks to address this gap by examining QoL (functional status, physical symptoms), psychological distress (depression and anxiety), and their associations with socio-demographic factors (age, sex, educational level), as well as clinical factors (e.g., stage of advanced cancer, location, histology, type of systemic treatment, estimated prognosis) in a cohort of patients with unresectable advanced cancer.

Design and Participants

NEOetic is an observational, prospective, cross-sectional study conducted by the Bioethics Group of the Spanish Society of Medical Oncology (SEOM) in collaboration with 18 Spanish medical oncologist departments. The study was approved by the Spanish Agency for Medicines and Health Products and the ethics committee of all participating centers. The project was conducted in accordance with the Good Clinical Practice guidelines and the latest version of the Helsinki Declaration, and all participants provided written, informed consent prior to enrollment.

The target population compromised adults (> 18 years) diagnosed with histologically confirmed advanced cancer (locally advanced or metastatic cancer not amenable to resection) and eligibles for systemic cancer treatment. Exclusion criteria included individuals with dementia or any other serious mental illness that prevented them from understanding the purpose of the study and the questionnaires, as well as patients who had received treatment for another advanced cancer in the preceding four years.

Measures

Data regarding medical characteristics, socio-demographic information, psychological distress, and QoL were collected and managed through the website (http://www.neoetic.es/) by the medical oncologist. The medical oncologist obtained information related to the patient's cancer from their medical records. Patients provided socio-demographic information (age, sex, educational level, professional and family status) and information on psychological distress and QoL through questionnaires. The patient was instructed to complete the Spanish validated versions of the Brief Symptom Inventory (BSI-18) and European Organization for Research and Treatment of Cancer QoL Questionnaire (EORTC-QLQ-C30) at home after the first visit with the oncologist. They were required to submit the questionnaires to the support staff at the subsequent visit before initiating cancer treatment.

The BSI-18 is a widely used instruments to measure anxiety and depression in individuals [9]. The scale compromises of 18 items, however, only the 12 items related to the anxiety and depression subscales were analyzed, as the somatization scale could be misinterpreted with physical symptoms assessed in the QoL scale. It has been observed that these 12 items can be categorized into two subscales, each containing of 6 items. The anxiety subscale evaluates symptoms such as nervousness, tension, motor restlessness, apprehension, and panic states, while the depression subscale assesses symptoms of disaffection, dysphoric mood, self-loathing, anhedonia, hopelessness, and suicidal ideation. Each item is rated on a 5-point Likert scale and each subscale score is from 0 to 24, with higher scores indicating a greater level of anxiety or depression. Raw scores are converted to T-scores based on gender-specific normative data and the BSI-18 applies the clinical case-rule originally developed for SCL-90 to identify individuals with significant levels of anxiety and depression [10]. According to the cut-off values suggested by Derogatis [9], patients with a T score is of 67 or higher are considered to have “possible anxiety or depression”, while those with a T score of 63 of higher are considered to have “probable anxiety or depression”. Additionally, the Cronbach’s alpha for the anxiety and depression scales in Spanish patients is 0.89 and 0.83, respectively [11].

EORTC-QLQ-C30 version 3.0 includes 30 items with five multi-item functional scales (physical, role, cognitive, emotional, and social), three multi-item symptom scales (fatigue, nausea and vomiting, and pain). Additionally, six single-item assessments of common symptoms experienced by cancer patients (dyspnea, insomnia, appetite loss, constipation, diarrhea, and the perceived financial difficulties impact of the disease and treatment), and a two-item global health status/QoL scale are included [12]. The questionnaire uses a 1-week time frame and a 4-point Likert-type response scales (“not at all,” “a little,” “quite a bit,” and “very much”), except for the two items of the global health status/QoL scale which use a 7-point response scale. We used the validated version of the questionnaire for a Spanish oncology population, and we evaluated the functional and multi-item and six single-item symptom subscales. The scores were linearly converted to a 0-100 scale to indicate a higher level of functioning on the functional scales, and more severe symptoms on the symptom scales [12]. According to the thresholds for clinical importance (TCIs) value recommended by Giesinger et al. [13], a score of ≥ 69 is indicative of higher level of functioning on functional scale, and a score of ≥ 30 is indicative of a more severe symptom on symptom scale. In this study, Cronbach’s alpha for the Spanish scale was 0.86 [14].

Statistical analysis

Descriptive statistics, including means, standard deviations, and frequency distributions, were calculated for all variables studied. Multivariate analysis was employed to create models with functional (EORTC-QLQ-C30-A), symptoms (EORTC-QLQ-C30-B) scale, anxiety (BSI-C), depression (BSI-D) and psychological distress (BSI-E) as dependent variables. Covariates incorporated in the models included age, sex, marital status, education level, cancer stage and primary site, performance status measured by the Eastern Cooperative Oncology Group (ECOG) scale, and cancer histology. A stepwise model with backward and forward selection, as well as the Akaike information criterion (AIC) was utilized. The forest plot depicted the proportions of patients experiencing anxiety, depression, psychological distress, functional impairment, and symptoms based on the covariates. A statistical significance level of 0.05 was established. All statistical analyses were conducted using the IBM-SPSS software package version 26.0 (SPSS, INC., Chicago, III).

Baseline characteristics

A total of 567 patients were assessed, with 540 included in the study based on the inclusion and exclusion criteria. Table 1 presents the baseline characteristics of the sample. The mean age was 64.8 years (standard deviation = 10; range 34–89), 54% were male, and 34% had no tumor symptoms prior to systemic treatment (ECOG 0). Up to 67% of patients had more than four comorbidities according to the Elixhauser criteria. Sixty-seven percent were married or in a partnership, 48% had a primary school education, and 48% were retired or unemployed. The most common type of cancer was lung (29%), followed by colorectal (16%), and pancreatic (11%). Adenocarcinoma was the most frequent histology (63%), and 16% of the cancers were a recurrence of a previously non-advanced neoplasm. Most cancers were at stage IV (80%) while 20% being locally advanced and unresectable.

Table 1

Baseline characteristics (n = 540).
Variables		Overall cohort n (%)
Age (year old)	≤ 65	254 (47)
	> 65	286 (53)
Sex	Male	290 (54)
	Female	250 (46)
ECOG performance status	0	185 (34)
	≥ 1	355 (66)
Elixhauser comorbidities	≤ 4	178 (33)
Elixhauser comorbidities	> 4	362 (67)
Marital status	Married or partnered	453 (84)
	No partnered	87 (16)
Educational level	Primary school and below High school and above	259 (48) 281 (52)
Employment status	Employed	264 (52)
Employment status	Retired or unemployed	243 (48)
Primary tumor site	Lung	158 (29)
	Colorectal	86 (16)
	Pancreas	58 (11)
	Breast	38 (7)
	Stomach	25 (5)
	Others	175 (32)
Histology	Adenocarcinoma	339 (63)
	Others	201 (37)
Recurrent cancer	Yes	84 (16)
	No	456 (84)
Stage	Locally advanced	456 (84)
	Metastatic	431 (80)
Biomarker-based therapeutic decisions	No Yes	397 (74) 143 (26)
Patient-estimated survival	≥ 18 months	269 (49)
	< 18 months	271 (51)

Treatment decisions were based on molecular biomarkers in 26% of cases. Most patients received chemotherapy (79%), targeted therapy with or without chemotherapy (21%), or immunotherapy with or without chemotherapy (17%). The estimated median overall survival, as reported by the medical oncologist, was less than 18.1 months for 51% of the sample. This information is summarized in Table 2.

Table 2

Systemic cancer treatment (n = 540).
Variables	Cohort n (%)	Drug	Percentage
Chemotherapy	429 (79.4)	Oxaliplatin	32.9
Chemotherapy	429 (79.4)	Fluorouracil	32.2
		Adriamycin	25.7
		Cisplatin	21.2
		Gemcitabine	15.8
Targeted therapy	116 (21.4)	Bevacizumab	29.1
		Panitumumab	10.8
Immunotherapy	94 (17.4)	Pembrolizumab	69.0
Immunotherapy	94 (17.4)	Atezolizumab	10.3
		Nivolumab	10.3
		Durvalumab	6.2
Hormone therapy	19 (3.5)	Aromatase inhibitor	60.0

Psychosocial distress and quality of life

This study revealed that a significant proportion of the patients (71%) experienced moderate to severe psychological distress on the BSI-18 scale. The distress was correlated with both functional (55%, ꭕ2 = 88.009; p = 0.001) and symptom problems (87%; ꭕ2 = 50.640, p = 0.001). As observed in Fig. 1, physical and emotional functioning were the most affected, while fatigue, nausea and vomiting, and insomnia were the most common symptoms reported.

The BSI-18 scale revealed a high rate of depression (71%) and anxiety (63%) among the studied population. Specifically, depression was found in 63.9% of females, 61.9% of males and 63.2% of those aged less than 65 years, 62.3% of those aged more than 65 years, 63.3% of those with a primary education, and 62.2% of those with a high school education. Similarly, anxiety was present in 65.7% of female, 63.1% of males, 65.1% of those aged less than 65 years, 63.6% of those aged more than 65 years, 65.1% of those with a primary school education and 63% of those with a high school education. Patients reported an average score of 69.1 (SD = 23) on the functional scale and an average score of 29.4 (SD = 21) on the symptom scale. Furthermore, most patients showed improvement in their functional abilities, with 72.9% of male and 64.5% of female, 68.9% of those under 65 years of age, 69.2% of those over 65 years of age, 68.1% of those with a primary school education and 69.92% of those with a high school education exhibiting such improvement. In contrast, the rate of significant deterioration of the symptoms scale was high, with 32.2% of females, 26,9% of males, 31.1% of those aged less than 65 years, 27.8% of those aged more than 65 years, 31.1% of those with a primary school education, and 27.8% of those with a high school education experiencing it.

The forest plot in Fig. 2 demonstrates the association between sociodemographic and clinicopathological variables and functional problems, symptoms, and anxiety, depression, and psychological distress. Males and patients with good performance status (ECOG 0) showed higher level of functional scale. Conversely, older age, adenocarcinoma histology, and worse ECOG (≥ 1) were associated with increased symptoms. Patients with lower education levels experienced higher levels of anxiety and depression. Psychological distress was more prevalent among younger patients and those with lower education.

No association was observed between clinical variables like stage and location of the cancer, socio-demographic factors such as marital status, and the occurrence of QoL impairment or distress.

This study examined a sizable sample of patients with advanced and unresectable cancer who were about to begin systemic antineoplastic treatment. Remarkably, this study highlights a modern approach to cancer treatment, incorporating innovative therapies beyond traditional chemotherapy, which has been the mainstay in earlier studies. In this series, 26% received treatment based on a biomarker, 21% underwent a biological treatment, and 17% were prescribed immunotherapy. The results demonstrated a correlation between socio-demographic characteristics (age, sex, and educational level), clinical variables (performance status and histology) and psychological distress, depression, and anxiety, and QoL variables (functional status, physical symptoms). Notably, the incidence of anxiety, depression, decreased functioning, and increased symptoms was high overall.

Women showed a greater decline in functional status than men. Older individuals presented with a greater number of symptoms, while younger individuals exhibited more psychological distress. Patients with a poorer performance status had more symptoms. Those with a lower level of education experienced higher levels of psychological distress, anxiety, and depression. Finally, patients with a histological subtype of adenocarcinoma had more symptoms than those with other cancer types.

Our sample presented more limitations in functional status and symptoms compared to another Spanish sample that included patients at any tumor stage [5]. The median functional status was 69 and the median symptoms was 29, in contrast to 86.8 for functional status and 15.3 for symptoms in a sample of patients without cancer [5]. Our results on the EORTC-QLQ-C30 scale indicate a wide range of physical symptoms among patients with advanced cancer. The three most common symptoms reported were fatigue, nausea, and insomnia. Furthermore, 55% of patients reported psychological distress in association with physical problems, and 87% reported symptoms, suggesting that these patients require support that goes beyond addressing physical complaints alone. Future studies should focus on interventions to improve physical wellness of these patients, including educational and psychosocial material to help them communicate their symptoms more effectively and mitigate their emotional and physical problems.

Our study found that patients with advanced cancer have a higher likelihood of experiencing high levels of anxiety and depression compared to patients with localized cancer. In a cohort of 600 patients prior to initiating adjuvant therapy, a prevalence of anxiety and depression of 49.8 and 36.6%, respectively was reported which is lower than what we found in our work with metastatic and advanced unresectable cancer patients [15]. Our study revealed that 63% and 71% of patients reported anxiety and depression, respectively, which is slightly lower than what was reported in a smaller sample of 158 Spanish patients with advanced cancer, where levels of anxiety were 72 and 88%, respectively [16]. While the incidence of anxiety in other series ranges between 24% and 59%, and that of depression between 25% and 60%, both slightly lower than in our sample. However, it should be noted that the studies mentioned used different measurement methods, sample sizes, scales, and interpretation of the results [8, 17].

Our study also revealed various trends. Patients with good performance scores and men reported higher levels of functionality. As expected, worse ECOG scores, older age, and lower educational levels were associated with more physical symptoms. Women and patients with lower educational levels presented more anxiety and depression, which is consistent with a series of patients in the adjuvant setting in Spain [18, 19]. Women, younger patients, and patients with lower educational levels reported more psychological distress. These findings suggest that men and women may respond and cope with their cancer differently and may require different interventions or a specific protocol according to sex to manage their emotions and communicate their needs effectively.

Several limitations of this study should be acknowledged. Firstly, the assessment was conducted post-diagnosis and pre-treatment, which limits our ability to estimate temporal variations accurately. Secondly, the lack of correlation between the primary cancer location and stage (unresectable locally advanced or metastatic) and QoL or psychological distress may be due to the small representation of cancers outside of breast, gastrointestinal tract, and lung, as well as those that are locally advanced and unresectable (20%). Thirdly, the estimation of psychological distress, anxiety, and depression relied on questionnaire without a medical assessment or diagnosis. Finally, the self-reported nature of the questionnaires completed by the patients may have introduced biases in the interpretation of symptom severity, the understanding of the questions asked, or in changes of opinion depending on the time of completion.

Our study presents several strengths that contribute to the validity and reliability of our findings. Firstly, the study had a sizable sample size and was conducted at multiple centers, providing a robust representation of patients with advanced cancer in the age of precision medicine treatments, such as biologics and immunotherapies. Secondly, our results are consistent with previous studies published on this topic [3, 4, 18], supporting the generalizability of our findings. Additionally, we identified a possible correlation between sex, age and educational level with psychological distress, which is a novel finding that warrants further investigation. Moreover, our study demonstrates a higher incidence of psychological distress in patients with advanced unresectable cancer compared to what has been reported in patients with localized disease [15, 20], confirming the impact of disease extension on the emotional and psychological well-being of patients with cancer. This is particularly relevant when considering previous studies, including a review [21], which have demonstrated the impact of quality of life on survival. Finally, our data suggest that patients with unresectable advanced cancer have a high burden of psychological distress, functional impairment, and a high number of symptoms highlighting the need for interventions that address the comprehensive care of these patients.

In summary, our study shed light on the differential experiences of patients with advanced cancer based on gender, age, performance status, histological subtype, and education. Female patients reported more depression, anxiety, psychological distress, functional impairment, and symptoms than their male counterparts, while elderly patients had more symptoms and younger patients had more psychological distress. Patients with impaired performance status had a further decline in QoL, and those with adenocarcinoma histological subtype had more symptoms, whereas patients with lower education levels had more psychological distress. Notably, our study did not find any correlation between QoL and primary cancer location. These findings underscore the need for tailored interventions that address the complex and multifaceted needs of patients with advanced cancer, with a particular focus on the distinct experiences of different patient subgroups.

AIC Akaike information criterion

BSI-18 Brief Symptom Inventory

ECOG Eastern Cooperative Oncology Group

EORTC-QLQ-C30 European Organization for Research and Treatment of Cancer QoL Questionnaire

QoL Quality of life

SEOM Spanish Society of Medical Oncology

TCIs Thresholds for clinical importance

Ethics approval and consent to participate

This study was performed in line with the principles of the Declaration of Helsinki and was approved by the Research Ethics Committee of the Principality of Asturias (May 17, 2019) and by the AEMPS (May 8, 2019; number: D57DG38BFB). This study is an observational, non-interventionist trial.

Informed consent was obtained from all individual participants included in the study.

Consent for publication

Not Applicable.

Availability of data and materials

Statistical analyses were performed with Statistical Package for Social Sciences (SPSS) software, 25.0 version (IBM SPSS Statistics for Windows, Armonk, NY: IBM Corp). The code is available upon request to the authors.

Competing Interests

PJF has received speaker honoraria from Adacap, Astellas, BMS, Lilly, MSD. RHSG has received speaker and consultant honoraria from Servier, Lilly, Roche, and Amgen; has served on advisory boards for Lilly and Amgen, and has received travel support from Roche, Amgen, and Merck. PCC has received speaker and consultant honoraria from Pfizer, MSD, and Astra Zeneca. AFM has received speaker and consultant honoraria and has served on advisory boards for Lilly, Roche, Astra Zeneca, Eisai, Pierre Fabre, Merck, Amgen, Servier, and has received travel support from Roche, Pierre Fabre, and Amgen. CCS CCS has received speaker and consultant honoraria from Servier, Guardant health, Pierre-Fabre, and has received travel support from Pierre-Fabre. MMM has received speaker and consultant honoraria from Pierre Fabre and has served on advisory boards for Novartis. RGM has received speaker and consultant honoraria from Servier, MSD, Roche, and Merck; has received travel support from Lilly, Servier, Pfizer and Roche. MGR has received speaker and consultant honoraria from Servier, Lilly, Merck, and Amgen; and has received travel support from Lilly, Servier, Amgen and Merck. LMG, EML, and CC declare they have no financial interests to disclose in the scope of this work.

Funding

This work is funded by the FSEOM (Spanish Society of Medical Oncology Foundation) grant for Projects of the Collaborative Groups in 2018 and by an Astra Zeneca grant.

The sponsor of this research has not participated in data collection, analysis, or interpretation, in writing the report, or in the decision to submit this article for publication.

Authors´ Contributions

The groundwork of this study, including conceptualization, design, material organization and analysis, was led by LMG, PJF, and CC. RHSG, PCC, AFM, CCS, EML, MMM, RGM, MGR actively participated in data collection. The preliminary draft of the manuscript was penned by LMG, PJF, CC, who received feedback from RHSG, PCC, AFM, CCS, EML, MMM, RGM, MGR on earlier manuscript versions. Each author reviewed and endorsed the final version of the manuscript.

Acknowledgments

Appreciation is extended to the NEOetic study investigators for their help with participant recruitment, to the SEOM Bioethics Section for their support of the study, and to Natalia Cateriano, Miguel Vaquero, and IRICOM S.A. for their backing of the online database.

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Competing interest reported. PJF has received speaker honoraria from Adacap, Astellas, BMS, Lilly, MSD. RHSG has received speaker and consultant honoraria from Servier, Lilly, Roche, and Amgen; has served on advisory boards for Lilly and Amgen, and has received travel support from Roche, Amgen, and Merck. PCC has received speaker and consultant honoraria from Pfizer, MSD, and Astra Zeneca. AFM has received speaker and consultant honoraria and has served on advisory boards for Lilly, Roche, Astra Zeneca, Eisai, Pierre Fabre, Merck, Amgen, Servier, and has received travel support from Roche, Pierre Fabre, and Amgen. CCS CCS has received speaker and consultant honoraria from Servier, Guardant health, Pierre-Fabre, and has received travel support from Pierre-Fabre. MMM has received speaker and consultant honoraria from Pierre Fabre and has served on advisory boards for Novartis. RGM has received speaker and consultant honoraria from Servier, MSD, Roche, and Merck; has received travel support from Lilly, Servier, Pfizer and Roche. MGR has received speaker and consultant honoraria from Servier, Lilly, Merck, and Amgen; and has received travel support from Lilly, Servier, Amgen and Merck. LMG, EML, and CC declare they have no financial interests to disclose in the scope of this work.

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Quality of Life and Psychological Distress in Advanced Cancer Patients: Associations with Sociodemographic and Clinical Factors

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Background

Methods

Design and Participants

Measures

Statistical analysis

Results

Baseline characteristics

Psychosocial distress and quality of life

Discussion

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