Abstract
Background. Anxiety and depression in cancer patients are associated with poor health-related quality of life (HRQOL). Clinical interventions to detect and support patients with these symptoms need to be developed and evaluated. We investigated the feasibility of screening with the Hospital Anxiety and Depression Scale (HADS) in a clinical oncology setting. In patients with anxiety or depression symptoms (HADS >7) we explored the use of clinical assessment and psychosocial support and described the development of anxiety, depression and HRQOL during a six-month period. Material and methods. Four hundred and ninety-five consecutive patients were screened for anxiety and depression at the time of their first visit at an oncology department (baseline). Half of the patients with HADS >7 on any of the two HADS subscales were referred to clinical assessment and psychosocial support (intervention group, IG) and half received standard care (SCG) using a historical control group design. HADS and EORTC QLQ-C30 were completed at baseline and after one, three and six months. Results. One hundred and seventy-six (36%) of 495 patients had anxiety or depression symptoms at screening, HRQOL at baseline was clearly impaired for them. Thirty-six (43%) of 84 IG patients attended clinical assessment, resulting in subsequent psychosocial support for 20 (24%) of them. In the SCG, only five (5%) patients attended clinical assessment after self referral, two received subsequent psychosocial support. Anxiety and depression decreased and HRQOL increased statistically significantly over time although anxiety was frequent and HRQOL impaired during the entire six month period. There were no differences between the SCG and IG regarding anxiety, depression or HRQOL at any time point. Conclusion. Systematic screening with HADS is feasible for oncology patients in clinical settings; it identifies patients with persistent symptoms and increases referral to clinical assessment and utilisation of psychosocial support.
Anxiety and depression in cancer patients are associated with poor health-related quality of life (HRQOL) [Citation1,Citation2]. Poor HRQOL indicates poor survival [Citation3]. More than one in four patients with cancer experience anxiety or depression during their illness and should be offered psychological and medical treatment [Citation4].
Oncologists and nurses lack appropriate methods to correctly identify cancer patients’ psychological concerns [Citation5,Citation6]. Especially patients with high levels of depression remain undetected [Citation1]. Use of screening instruments is one way to improve identification of patients with psychological problems, but there is a need to develop appropriate screening routines in oncology practice [Citation7,Citation8].
The Hospital Anxiety and Depression Scale (HADS) is widely used to screen for anxiety and depression in patients with cancer [Citation9,Citation10]. Among the short measures, the most extensive validation exists for the HADS across disease types and stages as well as across languages and cultures [Citation11,Citation12]. Screening with self-report measures has limitations in terms of the accuracy of detecting psychological morbidity, but it may serve as a first step in a process that should include follow-up to determine the need for further assessment or support [Citation13]. It is discussed whether or not psychosocial screening improves the psychological well-being in cancer patients, and further research to elucidate this question is needed [Citation14].
Patient's unawareness and personal attitudes may be an obstacle for receiving psychosocial support and treatment [Citation15]. Experiences of cancer-specific distress are significantly related to the use of psychosocial services [Citation16]. Cognitive behaviour therapy (CBT) has positive effects for cancer patients with anxiety, depression or low HRQOL [Citation17,Citation18].
In clinical oncology, we meet patients with various cancer diagnoses. Most studies in this area have focused on patients with specific cancer diagnoses. Breast cancer has served as a model for psychosocial programmes; however, studies including other diagnoses and men are needed [Citation19]. There is also a lack of knowledge concerning the development of anxiety and depression over time in patients with initial symptoms. Psychosocial issues such as anxiety and depression among cancer patients are well described in previous studies although many studies are limited to specific psychosocial topics such as prevalence [Citation7,Citation15,Citation20], screening [Citation2,Citation21] or support and treatment [Citation16,Citation17]. To our knowledge there are no studies evaluating the whole screening procedure including screening, follow-up, clinical assessment and psychosocial support and the effects of such an intervention on anxiety and depression during an extended time period.
The primary aim of the present study was to investigate the feasibility of systematic screening for anxiety and depression in a heterogeneous population of oncology patients at the time for their first visit to an oncology department. In patients with symptoms of anxiety or depression, further aims were: 1) to explore the use of clinical assessment and psychosocial support after individual referral compared to the use in standard care; 2) to explore the development of anxiety, depression, and HRQOL over a six-month period; and 3) to evaluate the effects of clinical assessment and psychosocial support on anxiety, depression and HRQOL compared to standard care during this period.
Material and methods
Design
This study had a prospective historical control group design. The intervention took part at the psychosocial outpatient clinic (POC) which was part of the regular services at the department. For that reason we first included the control group and then the intervention group to avoid interference with standard care routines regarding referral and utilisation of psychosocial support.
Patients and settings
Between September 2005 and June 2006, consecutive cancer patients, regardless of diagnosis, stage or time since diagnosis, were asked to participate in the study at the time (<1 month) of their first visit at the Department of Oncology, Uppsala University Hospital, Sweden. They were contacted by a research nurse (RN) by telephone or in person. Exclusion criteria were inability to speak and understand Swedish, cognitive inability or constant need of hospital care (Karnofsky <40). The Research Ethics Committee at Uppsala University approved the project.
A score of >7 on any of the two HADS subscales was regarded as indicating a potential need for clinical psychosocial assessment. We chose the cut-off score recommended for doubtful or clinical cases to reduce the number of undetected cases [Citation22].
During the first five months of the inclusion period, patients with a score >7 received standard care (Standard Care Group, SCG). During the following five months of the inclusion period patients with a score >7 received a telephone follow-up by the RN who recommended referral for clinical assessment and possible psychosocial support (Intervention Group, IG). Patients in the IG were referred to an oncology nurse with an undergraduate diploma in CBT at the POC, which was part of the regular services. All patients could be referred to, or contact POC themselves.
Standard care group
Patients in the SCG were informed that the aim was to study the occurrence of anxiety and depression among cancer patients. They were not informed about the results of the screening and they did not receive any information on additional psychosocial support besides the general information given in routine clinical practice.
Intervention group
Patients in the IG were informed that the aim was to study the occurrence of anxiety and depression and to evaluate the effects of clinical assessment and psychosocial support in patients with anxiety or depressive symptoms. The RN contacted IG patients by telephone within one week of the baseline assessment, and recommended referral to the nurse at the POC for clinical assessment and psychosocial support. If the patient consented, she sent the referral. Thus, not all patients in the IG who were recommended to undergo clinical assessment and psychosocial support actually chose to do so. The patients could also get an extra phone call from the nurse at the POC for further information about the intervention.
The clinical assessment (1–2 sessions, 45–60 minutes each) was performed face-to-face by the nurse and included an assessment of the patient's need for psychosocial support related to individual problems and other risk factors, an assessment of the patient's coping skills, social support and functioning and information about available support services. Decisions about continuing psychosocial support was made jointly by the nurse and the patient and depended on the degree of anxiety and depression, kind of problems and patient preferences.
Psychosocial support consisted of counselling, individual CBT, support groups or referral to other specialists. Counselling (1–2 sessions) included psycho-education, problem-solving and practical help, e.g. information and brochures from the Swedish Cancer Society or patient assistant organisations, fund applications for such as rehabilitation or direct economic support. Individual CBT (>2 sessions) was problem-focused and goal-oriented. The patient formulated their goals on a written handout between the first and the second session after the decision of an individual contact. Homework, depending on the type of problem and the goal were performed by the patient between the sessions. The last session contained a summing-up, how to move on using new strategies or acceptance, and an evaluation of the goals. The nurse received regular supervision from an instructor psychotherapist in CBT. Support groups consisted of education and support for patients and next of kin (six sessions), and the workshop Look Good Feel Better for women undergoing oncology treatment [Citation23]. Referral to other specialists included referrals to oncologist, GP, psychiatrist, speech therapist or social worker.
Data collection
Demographic and medical background data were collected from the medical records. All questionnaires were completed at baseline and after one, three and six months.
Anxiety and depression
The HADS was used for screening and assessment of anxiety and depression symptoms. It consists of 14 questions, seven measuring anxiety and seven measuring depression. The score for each scale is summarised with a maximum of 21 points. The recommended cut-off scores for each subscale are HADS <8 categorised as non-cases, HADS 8–10 as doubtful cases and HADS >10 as clinical cases [Citation22].
Health-Related Quality of Life
EORTC QLQ-C30 was used to assess HRQOL. It includes five functional scales, nine symptom scales and a global quality-of-life (QOL) scale. The scales are transformed to scores ranging from 0–100 [Citation24]. For functional scales and global QOL, a higher score means better level of functioning, while for the symptom scales, a higher score means more severe problems [Citation25].
Statistics
Statistical analyses were performed using SPSS Version 14. Missing values were replaced with the mean of each patient's responses, provided that at least half of the subscale items had been completed [Citation24]. The χ2-test and t-test were used for between-group comparisons at baseline. ANOVA with repeated measures was used to explore the development of anxiety, depression and HRQOL at one, three and six months and to analyse the effects of the intervention. Pairwise comparisons, in cases of statistically significant differences, were performed using least significant difference (LSD). The level of statistical significance was set at p ≤ 0.01. Data from all patients who completed the baseline and six-month assessments were used to explore changes in HADS case categories. Differences in EORTC QLQ-C30 scores from baseline to the six-month follow-up were interpreted in terms of clinical relevance as small (5–10 points), moderate (11–19 points) or large (≥20 points) mean changes [Citation26].
Results
Feasibility of screening
Six hundred and forty-four (86%) of 751 eligible patients were approached. A total of 547 patients (85%) gave their consent to participate in the study. Fifty-two dropped out before completing the baseline assessment. Thus, 495 (66%) of 751 patients were screened. The screening identified 92 patients with >7 on any of the HADS subscales during the first five months (SCG). Another 84 patients with >7 on any of the HADS subscales were identified during the following five months (IG) (). Twenty (24%) of 84 IG patients received psychosocial support.
Figure 1. Participant flow.
Regarding demographic and clinical characteristics there were no statistically significant differences at baseline between SCG and IG (data not shown) or between those who completed all four assessments (n = 108) and all patients at baseline (n = 176). The majority were women and married/cohabitant. Breast cancer was the most common diagnosis, followed by gastrointestinal and urogenital cancer. Time from diagnosis (date of histopathology report) to first visit was a median of five weeks (range 0–40 weeks). Eighty-four percent had a primary cancer; the majority had undergone surgery and had ongoing oncological treatment ().
Table I. Demographic and clinical characteristics for patients with anxiety or depression symptoms, HADS > 7 on any of the two subscales at baseline, n (%).
Use of clinical assessment and psychosocial support
Standard care group.
Five patients (5%) in the SCG met the nurse at the POC for clinical assessment and psychosocial support (two were referred and three self-referred). Three patients terminated after clinical assessment and two continued individual CBT (15–26 sessions).
Intervention group.
Following individual referrals, 36 (43%) IG patients attended clinical assessment (). In addition to anxiety and depression, problems with negative thoughts, emotional distress, body changes, communication to relatives, negative medical experiences and practical problems were uncovered at the clinical assessment. Sixteen patients terminated after the clinical assessment. Half of them were men and the mean age was 66 years. They had few problems which consisted of negative medical experiences, practical problems or anxiety; five patients were assessed with no present problems.
Figure 2. Flowchart of the intervention group, i.e. screening, follow-up, clinical assessment and psychosocial support for patients with anxiety or depression symptoms at baseline, HADS >7 No need (Űn = 25, Űn = 9), already established support (Űn = 6 Űn = 3), treatment in hometown or too far to travel (Űn = 6 Űn = 1), gave no reason (Űn = 5), not interested (Űn = 4), poor health (Űn = 2 Űn = 3). *Some patients (n = 9) used two support activities.
Twenty (24%) of 84 IG patients received continuing psychosocial support. The majority (80%) were women, the mean age was 62 years and at baseline the proportions of clinical cases for anxiety (50%) and depression (30%) were higher compared to patients who declined referral (anxiety 35%, depression 19%) and patients who terminated after clinical assessment (anxiety 38%, depression 0). Thirteen of the patients who continued psychosocial support received individual CBT (mean sessions = 7, SD = 5, range 3–20) and seven of them also used supplementary support services (referral to other specialists or group support).
Forty-eight (57%) of 84 patients declined referral. Three of them contacted the nurse one to six months later for assessment and psychosocial support. They had two sessions each, one patient died a few days before the scheduled follow-up session. All patients who received an extra phone call from the nurse (n = 15) for further information about the intervention still declined referral.
Effects of clinical assessment and psychosocial support
There were no statistically significant mean differences between the SCG and IG at baseline or at follow-up with regard to anxiety, depression or HRQOL ( and ).
Table II. Mean and standard deviation (SD) at all four points of assessments for patients with HADS > 7 on any of the two subscales at baseline, all assessments completed n = 108 (SCG n = 55, IG n = 53).
As SCG and IG were comparable on all variables, we present the following results for all patients with HADS >7 at baseline (n = 176).
Table IV. EORTC QLQ-C30 at all points of assessments for patients with HADS > 7 on any of the two subscales at baseline, mean, (SD) and clinically relevant mean changes, Baseline 1 = all patients at baseline n = 176, All° assessments completed n = 108, (SCG n = 55, IG n = 53).
Symptom development and HRQOL over time
Anxiety and depression.
Mean levels of anxiety (mean 10.4) was higher than those of depression (mean 7.6) at baseline. Anxiety decreased significantly from baseline to the one-month follow-up (F = 21.4, df = 3, p < 0.001), while depression decreased significantly from baseline to the six-month follow-up (F = 5.9, df = 3, p = 0.001) ().
The number of patients with clinical anxiety (HADS >10) was high at baseline (n = 53) and decreased to the six-month follow-up (n = 33). The number of patients with clinical depression (HADS >10) was almost unchanged from baseline (n = 21) to the six-month follow-up (n = 18) ().
Table III. HADS categorisations at baseline and at 6 months for patients with anxiety or depression symptoms, HADS >7 on any of the two subscales at baseline, n (%).
Health-Related Quality of Life.
At baseline the mean levels of global QOL, Role Functioning and Emotional Functioning were low. Emotional Functioning improved from baseline to the 1-month follow-up (F = 14.0, df = 3, p < 0.001). Global QOL, Role Functioning, and Social Functioning also improved over time (p ≤ 0.01) to the six-month follow-up. The levels of insomnia and fatigue were high at baseline. Insomnia, fatigue, and appetite loss improved (p < 0.01) to the six-month follow-up, and financial difficulties improved to the three-month follow-up (F = 7.2, df = 3, p < 0.001). Mean changes were of small or moderate clinical relevance ().
Discussion
To our knowledge, this is the first study evaluating the whole procedure to detect and diminish oncology patients emotional distress, i.e. from screening to follow-up, clinical assessment and psychosocial support as well as the effects on the development of anxiety and depressive symptoms and HRQOL over a six-month period in patients with initial problems, according to HADS screening. Systematic screening using HADS was feasible in a clinical oncology setting. Patients gave their consent to participate in the study to a great extent and the majority completed the study period, although some patients had poor health and most were receiving oncological treatments.
Forty-three percent of IG patients consented to referral and attended clinical assessment and half (55%) of them received subsequent psychosocial support. Contact with the nurse at POC, who was part of the department's routine activities, was rare (5%) in the SCG. Anxiety and depression decreased and HRQOL improved over time, although anxiety was frequent and HRQOL still impaired at the six-month follow-up. However, IG patients did not improve more than patients in the SCG.
The 36% of our study population identified as doubtful or clinical cases for anxiety or depression with HADS is consistent with the proportion of emotional distress detected in other studies looking at heterogeneous populations [Citation4,Citation7,Citation15]. There is probably no need to fear that screening will lead to the phenomenon of “opening Pandora's box”, as the majority of patients with symptoms of anxiety or depression in the present study declined referral, mainly according to “no need”. Although, our result with 43% of the patients consenting referral and attending clinical assessment was higher than in some previous studies where only 14–30% of the patients with distress wanted, maybe wanted or eventually were referred to services [Citation21,Citation27–29].
Sellick et al., using the cut-off score of HADS >10 on any of the subscales or a combined score (anxiety and depression) of HADS >15, reported that most (84%) patients accepted a recommendation to referral and made an appointment with a psychosocial oncology professional [Citation10]. When we analysed our data using the higher cut-off scores, the proportion that consented to referral did not increase. Lack of knowledge about the purpose, contents and possible benefits of clinical assessment and psychosocial support may be one reason that patients declined, even if they had the opportunity to ask the RN on the phone or to get more information through the extra phone call from the nurse at POC. According to Carlson et al., only a third of distressed patients reported past, current or future utilisation of psychosocial services. The main reason for non-use was a belief that they did not need any help, followed by lack of knowledge about the services provided [Citation15]. In our study, the patients could of course decline referral. If the intervention had included a strong recommendation to attend an assessment session, rather than an offer, perhaps more patients would have accepted this. Our clinical experience is that some patients hesitate to accept a referral, but change their minds and appreciate it after the first session. The proportion of IG patients who accepted the referral (43%) was lower than we had expected, although much higher than referred in the SCG (5%), which indicates that individual referral based on screening may be one way of breaking barriers to patients’ obstacles to use support services.
We chose heterogeneous patients at their first visit to the oncology clinic as we wanted to study a clinical sample and include all patients early in the contact. The great majority were receiving curative oncological treatment. At that period of the disease the patients have access to medical staff for information and support and the patient is often focused on managing the oncological treatment and its side effects. Patients may also wish to limit the number of visits to the hospital and therefore decline referral and support.
According to our results, the screening with HADS overestimated the prevalence of patients with psychosocial needs. We were aware of that risk by using the cut-off scores for doubtful cases. We accomplished the screening procedure with telephone follow-up, clinical assessment and psychosocial support options and by that almost half of the identified patients got individualised assessment and for about one-quarter it led to subsequent psychosocial support. For the IG patients who utilised the psychosocial support the proportion of clinical cases for anxiety or depression was high at baseline, the majority received individual CBT and about half of them also required supplementary psychosocial support interventions which indicate that this screening procedure may be efficient to identify patients in need of support and treatment.
The screening and assessment procedure lead to at least some support and treatments for 24% of the IG patients compared to 2% in SCG. Individual CBT was utilised in about 15% and 2%, respectively. With this low utilisation, it is not surprising that there were no measurable effects of the intervention when analysed in the entire group of patients. Yet, we claim to pay attention to the useful and beneficial screening and assessment procedure in order to individualise support and treatment in heterogeneous cancer patients.
The levels of anxiety and depression decreased significantly over time, which has been reported previously [Citation30–32]. Still the mean levels at the six-month follow-up were above the cut-off score for anxiety. HRQOL was also impaired both at baseline and at the six-month follow-up. Our results indicate the need of studies with long-term follow-up of symptom development in patients with initial symptoms of anxiety or depression. In a large longitudinal study of the impact of symptom burden on HRQOL in cancer survivors participating in a rehabilitation programme, mean global QOL increased from baseline to one and six months follow-up, however, at the 12 months follow-up, QOL decreased for patients with prostate-, lung-, cervix- or ovary cancer [Citation33].
There were no differences regarding anxiety, depression or HRQOL at baseline for those who completed all four assessments compared to those 50 patients who discontinued. Regarding demographic and clinical characteristics there were some differences; a higher proportion of patients who discontinued was in a more advanced disease stage (distant metastases or inoperable cancer), GI cancer was the most common diagnosis, the majority were men and the youngest and the oldest patients were among the individuals who discontinued. The results may have been different if this group had been able to complete the study.
In previous meta-analysis validation studies of the HADS for screening, the HADS show both strengths and limitations and the cut-off scores are evaluated and questioned. The subscales as well as the total cut-off score performed poor and is not recommended as an instrument for case-finding of depression, anxiety or any mental ill health/distress [Citation34,Citation35]. Although the HADS has limitations it also has advantages; it covers both anxiety and depression, it is a short questionnaire with high acceptability in patients and its psychometric properties perform well for screening [Citation35]. Based on our clinical experience, the patients in our study had much fewer problems compared to regular cancer patients referred to psychosocial support. The HADS identifies anxiety and depression, but there are other psychosocial problems that may be of greater concern for the patients and the HADS may not pick up all patients with significant broadly defined emotional complications or distress.
Limitations
The use of a historical control group design has some limitations. We do not claim to have conducted a strict intervention study, as our main aims were to evaluate the feasibility of screening with HADS in a clinical setting, and the use of clinical assessment and psychosocial support after individual referral in patients with symptoms of anxiety or depression, according to HADS. The preferred design in intervention studies is otherwise the randomised controlled trial (RCT). However, it was not feasible to use this method, because patients randomised to a control group in an RCT would receive concurrent information about the possibility to be referred to or to contact the nurse at POC themselves, as the intervention took part at the regular psychosocial services at the department. Thus, the use of psychosocial support in the SCG could probably increase resulting in a group of patients that differs from both the IG and patients in routine care.
The results of the assessment and the support intervention were negative, as no differences at any scale at any time point between the groups were seen. To argue pursuing this road further may be questioned considering the negative results both concerning the patients’ willingness to participate in the assessment and support activities and the lack of effect. Nevertheless, cancer patients with anxiety, depression and other psychosocial needs are still undetected and untreated in clinical practice. Future studies regarding the effects of clinical assessment and psychosocial support on anxiety and depression should preferably use the RCT design; include larger samples of screened patients and a longer follow-up period.
Conclusions
Systematic screening with HADS is feasible for oncology patients in clinical settings and increases the possibility for individual referral. Although, many patients identified by screening express “no need” for clinical assessment and psychosocial support. Anxiety, depression and HRQOL improve over time, but symptoms of anxiety and impaired HRQOL are still frequent at six-month follow-up. In the current study, patients referred for clinical assessment and psychosocial support did not improve more than patients in standard care.
Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.
The study was supported by grants from the Swedish Cancer Society, Uppsala County Council and the Faculty of Medicine, Uppsala University. The granting institutions had no role in the design of the trial, data collection, analysis, interpretation or writing of the manuscript.
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