Patient's perceived need and psychological distress and/or quality of life in ambulatory breast cancer patients in Japan
Objective: A needs assessment can be used as a direct index of what patients perceive they need help with. The purposes of this study were to investigate the association between patients' perceived needs and psychological distress and/or quality of life (QOL) and to clarify the characteristics of patients with a high degree of unmet needs.
Methods: Randomly selected ambulatory female patients with breast cancer participated in this study. The patients were asked to complete the Short-form Supportive Care Needs Survey questionnaire, which covers five domains of need (health system and information, psychological, physical, care and support, and sexuality needs); the Hospital Anxiety and Depression Scale; and the European Organization for Research and Treatment of Cancer QLQ-C 30.
Results: Complete data were available for 408 patients. The patients' needs were significantly associated with both psychological distress (r=0.63, p<0.001) and QOL (r=−0.52, p<0.001). A multiple regression analysis revealed that employment status (without full-time /part-time job), duration since diagnosis (less than 6 months), advanced stage, and a lower performance status were significantly associated with higher total needs. Only sexuality needs were significantly associated with a younger age, while the other domains were significantly associated with duration since diagnosis, advanced stage, and a lower performance status.
Conclusions: Moderate to strong associations exist between patients' needs and psychological distress and/or QOL. The characteristics associated with patients' needs are multi-factorial, and interventions to respond to patients' needs may be one possible strategy for ameliorating psychological distress and enhancing QOL. Copyright © 2010 John Wiley & Sons, Ltd.
Breast cancer is one of the most common cancers among women all over the world. In Japan, breast cancer is the most common cancer among women and its incidence is continuing to increase. At present, more than 40 000 women develop breast cancer annually in Japan. The psychosocial impact of breast cancer has received a good deal of attention because of the high prevalence of this disease and the severe psychological effects of both the cancer itself and its treatment. Previous studies have suggested that approximately 20–40% of breast cancer patients suffer from psychiatric morbidity, including depression and/or anxiety 1–3. This produces not only serious suffering 4, but also worsens quality of life (QOL) 5, reduces adherence to anti-cancer treatments 6, can lead to suicide 7, is a psychological burden on the family 8, and prolongs hospitalization 9.
As psychological functioning is a key dimension of a cancer patient's QOL, dealing with patients' psychological distress is an important part of clinical practice. We have developed several types of psychosocial intervention strategies for alleviating the psychological distress of cancer patients, including a multi-faceted psychosocial intervention program 10, a pharmacological treatment algorithm 11, and a nurse-assisted screening and psychiatric referral program 12. Based on these experiences, we have now set out to examine the needs of patients in order to develop a novel intervention program that will be more acceptable and satisfying to individual patients.
An assessment of needs offers a number of advantages. First, patients' perceived needs for help and patient-important outcomes can be directly assessed, enabling a more direct indication of the needed resources. Actually, the patients' problems and symptoms do not necessarily reflect the actual need for help 13. Second, it allows the magnitude of the need for help to be identified, thereby allowing some prioritization of service needs so that the available resources can be allocated where the need is most urgent. Third, a needs assessment enables individuals and/or patient subgroups with higher need levels to be identified, potentially enabling problems to be prevented or reduced through appropriate early interventions 14. Thus, understating the perceived needs of patients will enable the medical staff to develop services or interventions designed to meet these specific needs. Additionally, there are no large studies investigating the needs of breast cancer patients in an Asian country.
The purposes of the study were to investigate the association between patients' perceived needs and psychological distress and/or QOL and to clarify the characteristics of Japanese patients with a high degree of unmet needs. Our first hypothesis was that there would be statistically significant and more than moderate associations between patients' perceived needs and psychological distress and/or QOL. Our second hypothesis was that the clinical factors associated with patients with a high degree of unmet needs would be multi-factorial and that younger patients and patients with advanced cancer would have more unmet needs because some previous studies have suggested that younger breast cancer patients and patients with advanced breast cancer are more likely to experience clinical psychological distress 1, 15, 16.
The study subjects were ambulatory female patients with breast cancer attending the outpatient clinic for Oncology, Immunology, and Surgery at Nagoya City University Hospital between February 2006 and February 2007. Potential participants were sampled at random using a visiting list and a random number table.
The eligibility criteria for inclusion in the study were as follows: (1) a diagnosis of breast cancer (all stages and at any time point after diagnosis), (2) an age of 20 years or older, (3) an awareness of the cancer diagnosis, and (4) a general condition sufficient to enable the completion of the survey questionnaire (0–3 on the Eastern Cooperative Oncology Group [ECOG] performance status). The exclusion criteria were patients with (1) severe mental or cognitive disorders or (2) an inability to understand the Japanese language.
This study was approved by the Institutional Review Board and Ethics Committee of Nagoya City University Graduate School of Medical Sciences, Japan, and was conducted in accordance with the principles laid down in the Helsinki Declaration. Written consent was obtained from each patient after a thorough explanation of the purpose and method of the study had been provided.
After informed consent had been obtained, the patients were asked to complete the self-administered questionnaires (described below) at home and return them the following day. When questions were answered inadequately, clarifications were sought over the telephone.
Patients' perceived needs: The Short-form Supportive Care Needs Survey questionnaire (SCNS-SF34)
The SCNS-SF34 is a self-administered instrument for assessing the perceived needs of patients with cancer. The SCNS-SF34 consists of 34 items covering five domains of need: psychological (10 items), health system and information (11 items), physical and daily living (5 items), patient care and support (5 items), and sexuality (3 items). The respondents were asked to indicate the level of their need for help over the last month in relation to their having cancer using the following five response options (1 [No Need (Not applicable)], 2 [No Need (Satisfied)], 3 [Low Need], 4 [Moderate Need], 5 [High Need]). Subscale scores were obtained by summing the individual items. In addition, the total score was obtained by summing all the subscales (range = 34–170). A higher score indicated a higher perceived need. As an alternative use, the scale can be used to obtain information on the presence/absence and number of perceived unmet needs (a rating of 3 or higher was regarded as an unmet need), depending on the researcher's clinical question. The validity and reliability of the Japanese version of the SCNS-SF34 have been established 17.
Psychological distress: Hospital Anxiety and Depression Scale (HADS)
The HADS has been developed for use in medically ill patients and does not contain any questions regarding physical symptoms. The HADS is a self-reported questionnaire consisting of 14 items. The subjects are asked to rate how they felt during the previous week using a 4-point Likert scale. The HADS consists of an anxiety and a depression subscale (0–21 points each), and the total score can range from 0 to 42. A higher score indicates more severe depression and anxiety 18. The Japanese version of the HADS has been validated for cancer populations 19. The optimal cut-off point for screening for adjustment disorders and/or major depressive disorders (indicating psychological distress) was 10/11, while the cut-off for major depression (indicating serious psychological distress) was 19/20.
QOL: EORTC QLQ-C 30
Patient QOL was assessed using the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 20. The QLQ-C30 is a 30-item, self-reported questionnaire covering functional and symptom-related aspects of QOL in cancer patients. The validity and reliability of the Japanese version of the EORTC QLQ-C30 has been confirmed 21. In this study, the Global Health Status score was used. A high Global Health Status score represents a high QOL.
Sociodemographic and biomedical factors
An ad-hoc self-administered questionnaire was used to obtain information on the patients' sociodemographic statuses, including their marital status, level of education, and employment status. The performance status, as defined by the ECOG, was evaluated by the attending physicians. All other medical information (duration since diagnosis, clinical stage, and anti-cancer treatment) was obtained from the patients' medical records.
To investigate the association between the patients' perceived needs and psychological distress and/or QOL, Pearson's and/or Spearman's correlation analyses were conducted, as appropriate. To identify potential demographic, biomedical, and psychosocial factors associated with a high degree of unmet needs, we conducted a preliminary univariate analysis. In this preliminary analysis, the total and each of the five domains of the SCNS score were entered as dependent variables. The independent variables included age, marital status, employment status, living alone, education, duration since diagnosis (less than 6 months vs 6 months or longer), clinical stage (IV or recurrence vs other stages), performance status (defined by ECOG) and currently receiving anti-cancer therapy (surgery, chemotherapy, trastuzumab, and hormonal therapy: these therapies were rated as currently receiving when the subjects had received these therapeutic interventions within the previous month). For the univariate analyses, an unpaired t-test, Mann–Whitney test, chi-square test, Fisher's exact test, and Pearson's and/or Spearman's correlation analyses were conducted, as appropriate. After the univariate analysis, we used a multiple regression analysis to examine the final factors associated with patients' perceived needs. Independent variables with p values less than 0.10 in the preliminary univariate analysis were entered into the multiple regression analysis.
A p-value of less than 0.05 was regarded as being statistically significant, and all reported p-values were two tailed. All statistical procedures were conducted using SPSS version 15.0J version software for Windows (SPSS Inc., 2006).
A pool of 420 potential participants was identified for the study. Twelve patients were excluded: 7 refused to participate, 2 were excluded because of cognitive disturbances, 1 was excluded because of very advanced disease, and 2 were excluded for not providing responses despite consenting to participate. The sociodemographic and clinical characteristics of the remaining 408 patients are shown in Table 1. The mean (±SD) and median age of the study population was 56.1 (±12.1) and 55 years, respectively. More than three-fourths of the subjects were early breast cancer patients, and most of the patients did not have impairments of physical functioning. The mean (±SD) and median duration of days since diagnosis were 1040 (±1353) and 701 (range = 11–17915) days, respectively. The 25th and 75th percentiles of the duration of days since diagnosis were 200 and 1419 days, respectively. A total of 23% of the subjects had been diagnosed as having breast cancer within 180 days (6 months). Among the participants, 381 patients (93.4%) had undergone surgery. The HADS score suggest that 35% of the subjects suffer from clinical psychological distress (HADS⩾11) and 6% of the subjects experience serious distress (HADS⩾20).
Table 1. Characteristics of the study participants (n = 408)
|Age (in years)|
| mean: 56.1 (SD = 12.1), median: 55 (range, 27–89)|| || |
| Married|| || |
| > 12 years|| || |
| Full-time /part-time|| || |
|Duration since diagnosis (days)|
| mean: 1040 (SD = 1353)|| || |
| 25th percentile: 200|| || |
| 50th percentile (median): 701|| || |
| 75th percentile: 1419|| || |
|Current anticancer treatmentb|
| Hormonal therapy||195||48|
| Radiation therapy||9||2|
Frequency of unmet needs
The most common unmet need (rated 3 or more on the 5-point Likert scale) was shown in Table 2. ‘Fears cancer spreading’ was the commonest, followed by ‘Having one member of the hospital staff with whom you can talk to about all aspects of your condition, treatment and follow-up’, ‘Anxiety’, and ‘Being informed about things you can do to help yourself to get well’. The prevalence of the ten most frequent unmet needs was over 40%, and all of these unmet needs belonged to the psychological domain or the health system and information domain. Each patient had a mean (±SD) of 12 (±10) and a median of 10 unmet needs. The mean/median numbers of unmet needs in each domain were as follows: psychological needs (10 items), 4.4/4; health system and information (11 items), 4.4/3; physical and daily living needs (5 items), 1.4/0; patient care and support needs (5 items), 1.3/0; sexuality needs (3 items), 0.4/0.
Table 2. The prevalence of the ten most frequent unmet needsa of the study participants
|1. Fears cancer spreading||Psychological||258||63|
|2. Having one member of the hospital staff with whom you can talk to about all aspects of your condition, treatment and follow-up||Health system and information||225||55|
|3. Being informed about things you can do to help yourself to get well||Health system and information||207||51|
|5. Worry that the results of treatment are beyond your control||Psychological||198||49|
|6. Concerns about the worries of those close to you||Psychological||197||48|
|7. Having access to professional counseling if you, family or friends need it||Health system and information||184||45|
|7. Feeling down or depressed||Psychological||183||45|
|9. Feelings about death and dying||Psychological||164||40|
|10. Being informed about cancer which is under control or diminishing (that is, remission)||Health system and information||164||40|
Association between patients' perceived needs and psychological distress and/or QOL
The total score of the SCNS-SF34 was significantly associated with both psychological distress (HADS total: r = 0.63, p<0.001; HADS anxiety: r = 0.61, p<0.001; HADS depression: r = 0.55, p<0.001) and QOL (Global Health Status: r = −0.52, p<0.001). All of the needs scores evaluated using the SCNS-SF34, including psychological, health system and information, physical and daily living, patient care and support, and sexuality, were significantly associated with all the types of psychological distress evaluated in the current study (anxiety, depression, and total scores of the HADS). The correlation coefficients ranged from 0.24 (the association between HADS depression and sexuality needs, p<0.001) to 0.68 (the association between HADS total and psychological needs, p<0.001). Regarding the relation between the patients' needs and QOL, each of the needs scores of the SCNS-SF34 were significantly associated with the Global Health Status. The correlation coefficients ranged from −0.17 (the association between the Global Health Status and sexuality needs, p = 0.001) to −0.61 (the association between the Global Health Status and physical and daily living needs, p<0.001).
When comparing psychologically distressed patients (HADS⩾11) with those without distress (HADS⩽10), the distressed patients reported a higher number of total unmet needs (18.9 [SD = 9.8] vs 8.3 [SD = 8.5], p<0.001). Similarly, when seriously psychologically distressed patients (HADS⩾20) were compared with those without distress (HADS⩽19), the seriously distressed patients experienced a much higher number of total unmet needs (26.7 [SD = 6.9] vs 11.0 [SD = 9.7], p<0.001).
Characteristics of patients with a high number of unmet needs
Univariate analyses showed that employment status, duration since diagnosis, clinical stage, performance status, surgery, current chemotherapy, and current trastuzumab usage were significantly associated with the total needs. Current hormonal therapy was a borderline significant factor. A multiple regression analysis including these eight factors demonstrated that employment status, duration since diagnosis, clinical stage, and performance status were significantly associated factors with the total needs (Table 3).
Table 3. Factors associated with the patients' total needsa—Multiple regression analysis
|Employment status (Full-time /part-time)||−8.41||−0.14||−3.12||0.002|
|Duration since diagnosis (less than 6 months)||15.84||0.23||4.15||<0.001|
|Clinical stage (IV or recurrence)||15.76||0.20||3.84||<0.001|
|Current trastuzumab usage||4.64||0.03||0.66||0.51|
|Current hormonal therapy||3.10||0.05||0.99||0.32|
| || || || ||R2 = 0.19|
Regarding psychological needs, univariate analyses showed that employment status, duration since diagnosis, clinical stage, performance status, surgery, current chemotherapy, and current trastuzumab usage were significantly associated factors. A multiple regression analysis including these seven factors revealed that duration since diagnosis, clinical stage, and performance status were significantly associated factors (Table 4).
Table 4. Factors associated with the patients' psychological needsa—Multiple regression analysis
|Employment status (Full-time /part-time)||−1.73||−0.08||−1.81||0.07|
|Duration since diagnosis (less than 6 months)||6.07||0.25||4.49||<0.001|
|Clinical stage (IV or recurrence)||5.51||0.20||3.80||<0.001|
|Current trastuzumab usage||2.86||0.06||1.16||0.25|
| || || || ||R2 = 0.20|
Univariate analyses showed that employment status, duration since diagnosis, clinical stage, performance status, current chemotherapy, and current hormonal therapy were significantly associated with health system and information needs. Current trastuzumab usage was a borderline significant factor. A multiple regression analysis including these seven factors revealed that employment status, duration since diagnosis, and clinical stage were significantly associated with health system and information needs (Table 5).
Table 5. Factors associated with the patients' health system and information needsa—Multiple regression analysis
|Employment status (Full-time/part-time)||−4.30||−0.17||−3.58||<0.001|
|Duration since diagnosis (less than 6 months)||4.74||0.16||3.19||0.002|
|Clinical stage (IV or recurrence)||6.14||0.18||3.42||0.001|
|Current trastuzumab usage||0.20||0.003||0.07||0.95|
|Current hormonal therapy||−0.14||−0.005||−0.10||0.92|
| || || || ||R2 = 0.13|
Concerning physical and daily living needs, univariate analyses showed that employment status, duration since diagnosis, clinical stage, performance status, surgery, and current chemotherapy were significantly associated factors. A multiple regression analysis including these six factors indicated that duration since diagnosis, clinical stage, and performance status were significantly associated with physical and daily living needs (Table 6).
Table 6. Factors associated with the patients' physical and daily living needsa—Multiple regression analysis
|Employment status (Full-time/part-time)||−0.79||−0.09||−1.94||0.053|
|Duration since diagnosis (less than 6 months)||2.08||0.20||3.63||<0.001|
|Clinical stage (IV or recurrence)||1.36||0.12||2.21||0.03|
| || || || ||R2 = 0.18|
Univariate analyses showed that employment status, duration since diagnosis, clinical stage, performance status, and current chemotherapy were significantly associated with patient's care and support needs. Surgery and current trastuzumab usage were borderline significant factors. A multiple regression analysis including these seven factors revealed that employment status, duration since diagnosis, clinical stage, and performance status were significantly associated with the patient's care and support needs (Table 7).
Table 7. Factors associated with the patients' care and support needsa—Multiple regression analysis
|Employment status (Full-time /part-time)||−1.45||−0.15||−3.17||0.002|
|Duration since diagnosis (less than 6 months)||1.43||0.13||2.20||0.03|
|Clinical stage (IV or recurrence)||2.76||0.22||3.97||<0.001|
|Current trastuzumab usage||0.81||0.04||0.69||0.49|
| || || || ||R2 = 0.13|
Finally, regarding sexuality needs, univariate analyses showed that age and education were significantly associated factors. The duration since diagnosis was a borderline significant factor. A multiple regression analysis including these three factors revealed that only age was significantly associated with sexuality needs (Table 8).
Table 8. Factors associated with the patients' sexuality needsa—Multiple regression analysis
|Age (< 55 years)||0.89||0.19||3.63||<0.001|
|Education (<12 years)||−0.36||−0.08||−1.43||0.15|
|Duration since diagnosis (less than 6 months)||0.44||0.08||1.68||0.09|
| || || || ||R2 = 0.06|
The present findings indicated that moderate to strong associations exist between patients' needs and psychological distress and/or QOL and that the characteristics associated with patients' needs are multi-factorial.
The current study confirms our hypothesis that patients' perceived needs are significantly associated with both psychological distress and QOL. Regarding the association between patients' perceived needs and psychological distress, the findings obtained were consistent with those of a previous study 22, 23. On the other hand, the association between patients' perceived needs and QOL is somewhat controversial. Some studies have indicated a significant association between these factors in cancer patients 23 and among psychiatric patients 24, while other studies have shown no significant association 22. Although the current findings cannot reveal the causal association between patients' perceived needs and psychological distress and/or QOL, interventions to improve patients' perceived needs may be a promising strategy for ameliorating psychological distress and enhancing QOL among ambulatory breast cancer patients. Because the provision of medical services after the completion of a needs assessment can be adjusted to reflect the issues with which the patient desires help, this kind of intervention would be patient centered and would likely be acceptable to the patient.
Our second hypothesis was that the characteristics associated with a high number of unmet needs would be multi-factorial and that younger patients and patients with advanced cancer would have a greater number of unmet needs. The present findings partly supported these hypotheses. A general overview of the results shows that the period soon after cancer diagnosis (less than 6 months), a more advanced stage, and impaired physical functioning were associated with a higher number of unmet needs, whereas a full-time/part-time work status was associated with a lower number of unmet needs. These findings are useful for detecting potential patients with a high number of unmet needs and for developing strategies to reduce patients' psychological distress. One interesting finding may be the association between patients' needs and employment status. Because previous studies conducted in the general population have shown that work increases opportunities for adult relationships among females 25, employment may function as a resource for support for breast cancer patients. On the other hand, sexuality needs were unique, compared with other domains of needs. Sexuality needs were associated with a younger patient age, and this association was consistent with the results of previous studies 26. Several studies have demonstrated that sexually active breast cancer patients experience various sexual problems 27 and that younger breast cancer patients (<50 years) place a greater importance on information regarding sexuality than older patients 28. Thus, the sexuality needs of younger breast cancer patients should be carefully addressed, irrespective of other medical characteristics, including the duration since diagnosis, clinical stage, anti-cancer treatment, and physical functioning.
As mentioned above, patients with advanced stage cancer (metastatic and/or recurrent breast cancer) are likely to have a higher number of unmet needs. Clinical stage was associated with a higher number of unmet needs, and this association was independent of the period since cancer diagnosis and a lower physical function rating. Because patients with incurable cancer often confront many difficulties, including both physical and psychosocial issues, this finding is not surprising. As approximately half of breast cancer patients confronting advanced and/or recurrent disease clinically experience psychological distress 1, 15, future studies are needed to clarify the types of patients' needs and the factors associated with psychological distress among breast cancer patients with advanced disease so that their distress can be ameliorated.
Although it was not the principal purpose of our study, the current study demonstrated that the number of information and psychological needs was relatively high among breast cancer patients, compared with the other needs domains, and this finding was consistent with the results of previous studies among patients with other types of cancers 29–32. In particular, many breast cancer outpatients needed psychological help to manage their fear and/or anxiety, as shown by the number of responses to ‘Fears cancer spreading’ and ‘Anxiety’; these results are also consistent with those of a previous study 22. These findings suggest that the development of an interventional program for reducing fear/anxiety associated with recurrence and cancer spreading is needed for the treatment of breast cancer patients, as very few management strategies exist that specifically address these sources of distress 33. In addition, the findings that many ambulatory breast cancer patients still experience various unmet needs after 2–3 years after diagnosis suggest that development of appropriate support system for helping survivorship may be essential to care illness trajectory of breast cancer patients.
Because a previous study has shown that simple interventions, including a needs assessment and the feedback of the resulting information to oncologists, are not effective for reducing psychological distress among cancer patients 34, the development of more comprehensive or collaborative interventions might be needed to actually improve patient outcome. Considering the applicability of interventions in many clinical settings, one promising strategy may be a collaborative care model that is structured as an intervention program mainly provided by a nurse case manager supervised by mental health professionals 35. Furthermore, our findings suggest that interventions should often include active management strategies for reducing anxiety/fear and fulfilling information needs, based on each patient's specific needs.
Finally, we would like to comment on our findings from a cross-cultural perspective because, to the best of our knowledge, this is the first large Asian study to investigate breast cancer patients' need. There are many cross-cultural differences between Western and Asian countries, including differences in the expression of psychological distress (e.g. Asian depressive people are generally likely to be more somatized) and response to illness (e.g. Asian patients are more likely to respond stoically to their illness) 36, 37. On the other hand, the findings obtained in this study indicated that the most frequent need was ‘Fears cancer spreading’, and the psychological and health system and information domain needs were similar to findings in Western countries 38. Considering the various differences between these two cultures, these similarities are interesting, and further studies investigating patients' perceived needs from cross-cultural perspectives are needed.
In conclusion, the present study demonstrated that moderate to strong associations exist between patients' needs and psychological distress and/or QOL and these findings suggest that interventions to respond to patients' needs may be one promising strategy for ameliorating psychological distress and enhancing QOL. We are conducting a clinical trial to investigate the effectiveness of a collaborative care program led by a nurse supervised by psychiatrists for reducing psychological distress among breast cancer patients with high levels of distress.
The present study has several limitations. First, the investigation was cross-sectional in design, precluding any conclusions from being made with regard to causality between patients' needs and psychological distress and/or QOL. Second, we did not investigate several patients' demographic data (e.g. living levels) and clinical factors (e.g. the type of breast cancer surgery [mastectomy vs breast-conserving surgery], the occurrence of acute adverse effects of chemotherapy) which are potentially relevant. While previous studies suggest that the type of breast cancer surgery and treatment does not seem to impact on patients' psychological distress 39–41, economical status can influence patients' distress 42. Thus lack of data on patients' living levels is one of the limitation of the study and future study investigating the potential impact of economical status is promising. Third, because supportive care needs can be influenced by the patients' cultural backgrounds and each country's medical system, the findings might not be applicable to other patient populations. Fourth, since the present study was conducted at one institution, an institutional bias might exist. Finally, because this study focused on ambulatory breast cancer patients and relatively few patients with low physical functioning or advanced cancer were enrolled, the results might not be applicable to patients with other types and/or advanced stages of cancer.
This study was supported in part by a Grant-in-Aid for Scientific Research from the Japanese Ministry of Education, Culture, Science, and Technology and a Grant-in-Aid for Cancer Research from the Japanese Ministry of Labor, Health and Welfare.