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Original Article

Psychological distress in newly diagnosed breast cancer patients: an observational study comparing those at high risk of hereditary cancer with those of unknown risk

Wevers, Marijke R.a,b,c; Schou-Bredal, Ingerd; Verhoef, Sennoe,f; Bleiker, Eveline M.A.a; Hahn, Daniela E.E.g; Brouwer, Titiab; Kieffer, Jacobien M.a; Ausems, Margreet G.E.M.b; Aaronson, Neil K.a,∗

Author Information
Journal of Psychosocial Oncology Research and Practice: March 2020 - Volume 2 - Issue 1 - p e18
doi: 10.1097/OR9.0000000000000018
  • Open


1 Introduction

Newly diagnosed breast cancer patients commonly experience increased levels of psychological distress, and particularly anxiety and depression.[1–6] Women with hereditary breast cancer due to a germline BRCA1 or BRCA2 gene mutation have an increased risk of developing another, typically contralateral, breast cancer, and/or ovarian cancer.[7–10] Their family members are also potentially at risk of being predisposed to breast and/or ovarian cancer. Thus, breast cancer patients who know that they are at increased risk of having hereditary breast cancer may experience additional concerns that can also result in heightened levels of psychological distress.[11–13] More specifically, we are referring to women diagnosed with breast cancer who are at increased risk of carrying a BRCA1/2 mutation (eg, because of their young age at breast cancer diagnosis and/or having a positive family history of breast and/or ovarian cancer), but who have not yet undergone genetic testing. Thus, a diagnosis of hereditary breast cancer has not yet been made.

Studies on the psychological impact of genetic counseling and testing (GCT) have yielded varied results. Schlich-Bakker et al[14] found that breast cancer patients who were approached for genetic counseling within 2 months after surgery reported clinically relevant levels of distress with the same frequency as a comparison group of breast cancer patients with no indication for having hereditary cancer. However, in a literature review, the same authors found that high-risk breast cancer patients referred for GCT within 1 year after diagnosis reported higher levels of distress before genetic counseling than high-risk breast cancer patients who had received their breast cancer diagnosis longer ago, that is, up to 9 years after genetic testing.[15] Breast cancer patients who are informed that they are a BRCA1/2 mutation carrier often experience a negative effect on their psychological well-being in the first 6 months after test result disclosure.[16]

Studies of psychological distress have been reported for both newly diagnosed breast cancer patients, in general, and for breast cancer patients who were offered and/or received GCT after their (primary surgical) treatment. Schwartz et al[17] reported that newly diagnosed breast cancer patients with a family history indicative of hereditary breast cancer who were offered rapid GCT were more likely to wait for their test results before proceeding with definitive treatment if they had heightened anxiety. However, some of the patients in this study had already undergone breast surgery. To the best of our knowledge, no studies have yet investigated the specific subset of newly diagnosed breast cancer patients who are informed of being at high-risk of having hereditary breast cancer before any primary surgery has been initiated. It is unclear whether knowledge of being at high-risk, in and of itself, causes additional psychological distress.

It is expected that rapid GCT (RGCT) (ie, GCT after diagnosis but before primary surgery) will become widely available to newly diagnosed high-risk breast cancer patients.[18–22] Approximately 15% to 21% of newly diagnosed breast cancer patients may be eligible for GCT because of being at high risk of having hereditary breast cancer.[23,24] Thus, a sizeable group of newly diagnosed breast cancer patients will be informed of being at increased risk of having a genetic predisposition. Therefore, it is important to know whether being at risk of having hereditary breast cancer itself (before undergoing RGCT) entails additional distress. If being identified as being at high risk of hereditary breast cancer around the time of diagnosis proves to be an additional, significant source of psychological distress, then caregivers need to be alert to such a possibility, regardless of whether the patient does or does not choose to undergo RGCT. If necessary, patients can then be referred for (specialized) psychosocial counseling in time.

In the current study, we compared psychological distress levels of newly diagnosed breast cancer patients who knew that they were at increased risk of having a hereditary form of the disease (ie, who had at least a 10% risk of carrying a BRCA1/2 mutation) (labeled HRBC) with distress levels of breast cancer patients who were not assessed for and informed of such potential risk (labeled unknown risk breast cancer, or URBC). We hypothesized that knowledge of being at increased risk for having hereditary breast cancer shortly after diagnosis is associated with additional psychological distress.

2 Materials and methods

2.1 High-risk sample

Patients in the HRBC sample were Dutch women newly diagnosed with breast cancer with at least a 10% risk of carrying a BRCA1/2 gene mutation according to Dutch guidelines.[25,26] This was defined as either: being diagnosed with breast cancer at an age of 35 years or younger; having bilateral breast cancer with the first diagnosis under the age of 50 years; having a personal or family history of ovarian cancer; having a first-degree male relative with breast cancer; being diagnosed with breast cancer under the age of 50 years and having a first-degree relative diagnosed with breast cancer under the age of 50 years, or a relative with prostate cancer under the age of 60 years; having at least 2 relatives with breast cancer, where one of the family members (patient or relative) was diagnosed under the age of 50 years; or having a proven BRCA1/2 mutation in the family.[21] They were recruited between November 2008 and December 2010 as part of a randomized controlled trial (the TIME-trial) assessing the clinical and psychosocial impact of RGCT.[18,21,22] As part of this trial, they were informed of their increased risk of having hereditary breast cancer. For the purpose of the current analysis, we used the assessment that took place at baseline, before randomization.

2.2 Comparative sample of “general” breast cancer patients

Patients in the URBC sample were Norwegian women newly diagnosed with operable breast cancer at the Ullevaal University Hospital in Oslo in 2001 and 2002, who participated in a study that investigated the prevalence of emotional morbidity following a breast cancer diagnosis. These women were not assessed for or informed about possible risk of hereditary breast cancer, or about potential eligibility for GCT.[27,28]

We employed the high risk and comparative samples because they were the only samples available to us of newly diagnosed breast cancer patients who were assessed for psychological distress before primary surgery and before having undergone genetic counseling.

2.3 Study design and procedures

Both the HRBC and the URBC patients were asked to complete a questionnaire shortly after receiving their breast cancer diagnosis, and before primary surgery. Only patients who completed the questionnaires within 21 days after diagnosis were included in the analyses described in this article. Both the TIME-trial study of HRBC patients and the Norwegian study of URBC patients, respectively, were approved by the institutional review boards of the respective hospitals, and all patients provided informed consent.

2.4 Study measures

Patients in both the HRBC and the URBC samples completed a questionnaire including the 14-item Hospital Anxiety and Depression Scale (HADS).[29,30] Separate subscale scores can be generated for anxiety and depression, with scores ranging from 0 to 21 (higher scores representing more symptoms of anxiety or depression). For both subscales, a score of 8 to 10 is indicative of a suspected case of anxiety or depression, and a score of ≥11 is considered to be a probable case.[29,31,32] Thus, a score of ≥8 is indicative of a suspected or probable case. The HADS has been validated for use in the Dutch and Norwegian populations. Cronbach alpha coefficients for both the anxiety and depression scales are >.70.[30,32–34] Although the HADS was developed to differentiate between anxiety and depression, it is also often used to assess emotional distress, in general.[35]

Sociodemographic and clinical data were collected via self-report and medical chart review. Self-reported items included, for the HRBC sample, having had psychological problems in the year before diagnosis, which was defined as having had a depression or burn-out, or having been significantly nervous.

2.5 Statistical analysis

We used descriptive statistics to characterize the study samples and the Mann–Whitney tests and χ2 tests to compare groups on background variables.

We employed univariate analysis of covariance to test sample differences in mean levels of psychological distress, and logistic regression analysis to test for between group differences in the percentage of patients reporting a score of ≥8, and ≥11, on the anxiety and depression subscales of the HADS. Because a significant difference between the 2 samples was observed for a number of sociodemographic variables, these were used as covariates throughout the analyses.

We used univariate and multivariate logistic regression analyses to identify variables associated significantly with (probable) cases of depression or anxiety within the HRBC sample and URBC sample. Variables investigated included age at diagnosis, having children, education, marital status, occupational status, and having had psychological problems within the year before breast cancer diagnosis (for the HRBC sample only).

Statistically significant effects were accompanied by effect sizes, expressed as Cohen d statistic. Effect sizes at or above (−)0.5 were considered clinically relevant.[36]P values were set at 0.05, but at 0.1 for identifying predictors of psychological distress.

For all analyses, SPSS Statistics (IBM SPSS Statistics Corp., Armonk, NY) was used.

3 Results

3.1 Characteristics of the patient samples

3.1.1 High-risk breast cancer sample

Between November 2008 and December 2010, 265 high-risk women were recruited into the Dutch TIME-trial, of whom 238 completed the baseline questionnaire within 21 days of their breast cancer diagnosis.

3.1.2 General breast cancer sample

Between January 2000 and December 2001, 165 newly diagnosed URBC patients were recruited into the Norwegian study and completed the baseline questionnaire within 21 days of diagnosis. Of these 165, 4 (2%) were diagnosed at 35 years or younger, and 36 (22%) reported a positive family history of breast cancer.

3.1.3 Sociodemographic and clinical background characteristics

As compared with women in the URBC sample, women in the HRBC sample were significantly younger at breast cancer diagnosis, were more likely to have a partner, to be employed, to be highly educated, and not to have children (Table 1). The URBC sample included women with tumor stage T1 or T2. The HRBC sample consisted mainly of women with tumor stages T1 or T2 (52% and 30%, respectively), but also with stage T0/in situ (5%), stage T3 (6%), or other categories (eg, 7% bilateral breast cancer). We adjusted statistically for the differences in sample background characteristics in the analyses of the HADS data.

Table 1
Table 1:
Sample characteristics.

3.1.4 Prevalence of depression

Women in the HRBC sample reported significantly more symptoms of depression than women in the URBC sample (adjusted mean HADS scores [95% confidence interval, CI] of 5.4 [4.8–5.9] vs 3.7 [3.0–4.3], effect size 0.40, P < .001) (Table 2). Significantly more women in the HRBC than the URBC sample scored ≥8 on the HADS depression subscale, indicative of a possible case of depression (28.7% vs 11.5%, P = 0.001). Similarly, significantly more HRBC women scored ≥11 on the HADS depression scale, indicative of depression caseness (15.2% vs 4.8%, P = .01).

Table 2
Table 2:
Group differences in mean HADS anxiety and depression scores and in percentage of cases.

In the HRBC sample, having had psychological problems the year before diagnosis was associated significantly with a depression score of ≥8 and ≥11 (odds ratio [OR] 3.18 [95% CI 1.53–6.59], P < .01, and OR 4.36 [95% CI 1.97–9.62], P < 0.01 respectively); having children was associated significantly with a score of ≥8 (OR 2.21 [95% CI 1.10–4.41], P = .03; Table 3). In the URBC sample, having children was not significantly associated with scores above the cutoff points.

Table 3
Table 3:
Variables associated with a suspected or probable diagnosis of anxiety or depression within the high-risk breast cancer sample.

3.1.5 Prevalence of anxiety

Women in the 2 samples reported similar mean levels of anxiety (adjusted mean HADS scores [95% CI] of 8.9 [8.3–9.6] vs 8.6 [7.7–9.4], effect size 0.06, P = .56) (Table 2). The percentage of women with a HADS anxiety scale score of ≥8 was 61.4% and 50.3% in the HRBC and the URBC samples, respectively (P = .18). For a score of ≥11, the corresponding figures were 38.6% and 32.1%, respectively (P = .25).

In the HRBC sample, having had psychological problems the year before diagnosis and having children were associated significantly with a score of ≥8 and ≥11 (respective OR [95% CI] for having children 2.73 [1.51–4.93], P < .01, and 2.50 [1.32–4.74], P = .01; respective OR [95% CI] for having had psychological problems 2.55 [1.11–5.85], P = 0.03, and 3.62 [1.71–7.66], P < .01). Lower age at diagnosis was associated significantly with a score of ≥8 (OR 0.97 [95% CI 0.95–0.99], P = .01; Table 3). In the URBC sample, having children was not significantly associated with scores above the cutoff points.

4 Discussion

In this study, we investigated whether the prevalence of (symptoms of) depression and anxiety, as assessed by the HADS, differed significantly between women newly diagnosed with breast cancer who were informed of their increased risk of having hereditary breast cancer, and women who were not assessed for being at increased risk. Overall, as assessed within 3 weeks following breast cancer diagnosis, the HRBC group reported significantly higher mean levels of depression, and included more (suspected) cases of depression than the comparison group. The mean HADS depression scale score observed in the comparison group of Norwegian URBC patients was very similar to that of Norwegian[37] and Dutch (unpublished data obtained from the Profiles Registry) general population samples. In the HRBC sample, predictors of increased levels of depression were having children and having had psychological problems in the year before diagnosis. This was not surprising, as a history of psychiatric problems and having children at home have been reported as predictors of psychological distress in women with breast cancer.[38–40] Possible explanations for this last finding may be that women who care for children at home are facing greater demands in their role at home or that they are worried more about not being able to care for their under-age children.[40] Additionally, fear for their children having inherited the possible genetic predisposition may increase psychological distress as well.[41–43]

No significant group differences were observed in mean HADS anxiety scale scores or in cases of (suspected) anxiety disorder. Our results are similar to the mean anxiety scores reported by newly diagnosed breast cancer patients in a recent Danish study.[4] Importantly, however, both the mean HADS anxiety scale scores for the 2 groups as well as the percentage of patients with a (suspected) anxiety disorder were substantially higher than those observed for women from the general Dutch (unpublished data from the Profiles Registry) and Norwegian populations,[37] as well as for samples of high risk breast cancer patients assessed (long) after surgery.[14,44]

Although women in the URBC group were not assessed for or informed of whether being at increased risk of having hereditary breast cancer or not, some may have suspected having an increased risk based on their age or family history. This may have influenced their reported levels of psychological distress. To which degree is unclear, as we do not have any detailed information (first-, second-, or third-degree relatives being affected, and at what age) on their family histories.

Schlich-Bakker et al[14] investigated levels of psychological distress in high-risk and non–high-risk breast cancer patients 6 to 7 and 11 to 12 weeks after surgery, and did not find any significant differences. They found a significant decline in anxiety levels in non–high-risk breast cancer patients. A similar decline in levels of anxiety and/or depression has been shown in other studies as well,[2,18,45,46] and suggests that increased levels of psychological distress shortly after diagnosis are often self-limiting. Thus, the higher mean levels of depression shortly after breast cancer diagnosis in the HRBC group in our study may, in some cases, reflect a short-time effect. However, for some women, distress levels do not decline over time, and thus early detection of distress is important to provide appropriate referral and psychosocial support.[47,48] Based on Schlich-Bakker et al[14] this would concern about 10% to 13% of women. Routine screening for psychosocial distress has been advised to refer those in need of support,[49] with special attention to women with a recent history of psychological problems, having children and few social support.[14]

This study had several limitations that should be noted. First, in this study, we employed 2 patient samples that differed not only in exposure to information about their genetic risk status, but also in time period of assessment, sociodemographic characteristics, and in culture. We were able to adjust statistically for sociodemographic differences observed between the 2 samples. We could not, however, adjust for possible cultural differences between the samples. We would argue, however, that any cultural differences that may exist between the Netherlands and Norway in terms of symptom reporting are probably relatively minor. This is born out by the similarity in HADS normative scores for general population samples from these 2 countries (unpublished data obtained from the Profiles Registry and[37]). We would also note that the health care systems in these 2 countries are relatively similar. However, we cannot entirely rule out the possibility that subtle differences in the health care systems may have had some impact on the self-reported levels of depression. We also cannot exclude the possibility of a confounding effect of the difference in the time periods in which the data from the 2 samples were collected. It is likely, for example, that awareness of the possible hereditary nature of breast cancer has increased over time among women with breast cancer. However, even when the earliest data used in this study were collected, testing for mutations in the BRCA1 and BRCA2 genes had already been available for several years. If awareness of hereditary breast cancer has increased with time, its effect on women's distress levels would probably vary, depending on such factors as social support and coping style. We have no reason to believe that it would have any major, systematic effect on comparisons over time. Ultimately, it would be useful to replicate the current analysis using samples drawn from the same country and time period.

Second, the data used in this study were cross-sectional in nature. Thus, we do not know the natural history of depression and/or anxiety symptoms/disorders in the 2 samples that we compared. Although in the HRBC sample long-term levels of distress have been described at the group level,[18] we do not have comparable data for the URBC sample. Additionally, we do not have information on whether women received psychological counseling after their breast cancer diagnosis, and thus we would not be able to determine whether any changes over time in distress levels reflect self-limiting symptoms. Detailed longitudinal data are needed to determine the extent to which such symptoms are transient and self-limiting in HRBC patients, as has been described for breast cancer patients, in general[50] or, conversely, whether they are chronic in nature (at least in the absence of treatment).

Our study also has some major strengths, including relatively large samples, use of a standardized self-report measure of depression and anxiety, and use of statistical techniques to correct for differences in sample background characteristics, where possible. Ours is, to the best of our knowledge, the first study to attempt to evaluate the incremental psychological distress associated with being aware of one's risk of having been diagnosed with a hereditary form of cancer shortly after receiving a diagnosis of breast cancer.

5 Conclusions

Based on the results of this study, shortly after diagnosis, high-risk breast cancer patients report significantly higher levels of depression than patients who were not assessed for potentially increased risk of having a hereditary form of breast cancer. Although additional research is required, taking into consideration the caveats described above, we believe that our results are sufficiently robust to recommend that health care professionals be especially alert for psychological distress in women who are informed that they are at increased risk of having an hereditary form of breast cancer around the time of diagnosis. Women with children and those with a history of psychological problems may be particularly vulnerable to both depression and anxiety, and younger women to anxiety. We would also recommend use of a short screening questionnaire as a routine part of clinical care to detect women with high distress levels in a timely manner, and to refer those who so wish to appropriate psychosocial care. Although the evidence from our randomized controlled trial indicates that rapid GCT of women with a heightened risk of hereditary breast cancer does not appear to have any significant adverse psychological or psychosocial effects,[18] the current results suggest that the initial reaction to information about risk status may trigger depressive symptoms in a minority of women recently diagnosed with breast cancer.

Conflicts of interest statement

The authors declare no conflicts of interest.


The authors thank the participating surgeons, Thijs van Dalen, Evert B. Theunissen, Bart van Ooijen, Marnix A. de Roos, Paul J. Borgstein, Bart C. Vrouenraets, Eline Vriens, Wim H. Bouma, Herman Rijna, Johannes P. Vente, Arjen J. Witkamp, and Emiel J.Th. Rutgers for recruiting the patients into the TIME-trial.

The authors also thank Marianne A. Kuenen and Jacoline van der Sanden-Melis for their help with the data collection, and the Profiles Registry (Patient Reported Outcomes Following Initial treatment and Long-term Survivorship Registry) for providing us with reference HRQOL, anxiety and depression data of women from the general Dutch population.


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Anxiety; BRCA1/2; Breast cancer; Depression; Oncology; Psychological distress

Copyright © 2020 The Authors. Published by Wolters Kluwer Health Inc., on behalf of the International Psycho-Oncology Society.