Breast Cancer Research and Treatment 61: 145–150, 2000.
2000 Kluwer Academic Publishers. Printed in the Netherlands.
Patients’ understanding of their own disease and survival potential in
patients with metastatic breast cancer

Hitoshi Okamura1, Noboru Yamamoto2, Toru Watanabe2, Noriyuki Katsumata2, ShigemitsuTakashima3, Isamu Adachi2, Akira Kugaya1, Tatsuo Akechi4, and Yosuke Uchitomi11Psycho-Oncology Division, National Cancer Center Research Institute East; 2Department of Medical Oncology,National Cancer Center Hospital; 3Department of Surgery, National Shikoku Cancer Center Hospital; Chairmanof the Breast Cancer Study Group of the Japan Clinical Oncology Group (JCOG); 4Psychiatry Division, NationalCancer Center Hospital Key words: clinical trial, informed consent, metastatic breast cancer, survival, understanding Purpose: To investigate the effect of understanding their own disease by patients with metastatic breast cancer ontheir survival potential after being informed by their physician.
Patients and methods: Two hundred and fourteen women with metastatic breast cancer who participated in a multi-institutional, randomized phase III trial (Japan Clinical Oncology Group (JCOG) Study 8808) were askedwhether they understood their own disease after being given information about the clinical trial. They were classi-fied into two groups on the basis of whether they understood or not. We estimated their survival after the time ofregistration and derived relative hazard ratios from Cox’s proportional hazards model.
Results: There were 190 patients in the ‘better understanding’ group and 24 in the ‘poor understanding’ group.
Median survival times after registration were 28.3 and 16.1 months, respectively. The ‘better understanding’ groupshowed a significant difference from the ‘poor understanding’ group (p = 0.016). In multivariate regressionanalysis, patients who did not understand still showed poorer survival than those who understood (hazard ratio= 2.09; 95% confidence interval (CI) 1.16–3.78; p = 0.014).
Conclusion: These results support the supposition that patients’ understanding of information about their disease may influence their survival. Thus, it is important to evaluate patients’ recognition about informationeven after obtaining their consent. However, further investigation is needed to clarify the exact nature of thisrelationship.
Psycho-oncology research has shown that some psychosocial and behavioral factors such as social sup- Why is informed consent important for cancer pa- port [6], coping strategies [7], and psychiatric group tients? It has been emphasized that all cancer research interventions [8, 9] can contribute to cancer patients’ demands fully informed consent from all patients [1– quality of life or length of survival. Social or emotional 3], but an explicit answer to this question has not yet support is thought to promote biological or behavi- been provided. In randomized clinical trials, patients oral adaptation in the face of stress [10] and result should know about the potential randomization, all in better compliance with treatment [11]. Richardson the treatment options, and their own disease through et al. [12] found that improving patient compliance the information they are given. However, some reports with treatment was associated with significant pro- show that patients are not always given full informa- longation of patient survival. Furthermore, support tion [4] and that they do not always give their consent from the physician is reported to be the most important after they have understood the information [5].
source of support [13] and a significant predictor of coping response [14]. This means that support from age, marital status, Eastern Cooperative Oncology the physician help patients cope better with cancer Group performance status (PS), menopausal status, [15]. Better support from the physician leads to an disease-free interval (DFI), assigned therapy, recur- attitude of fighting spirit in patients [7, 16] or active rent or advanced disease, estrogen receptors (ER) and behavioral coping [9], which is associated with bet- progesterone receptors (PgR), axillary nodal status, ter survival. Psychiatric interventions are suggested history of adjuvant therapy, sites and number of meta- to foster improved health habits such as better nu- stases, blood counts, biochemical data, and serum tu- trition and exercise regimens, and enhance effective mor markers. Age, marital status, PS, and menopausal and active behavioral coping, resulting in improved status were determined at the time of registration. ER, physician–patient relationships, positive mental atti- PgR, and axillary nodal status were determined at tudes, and greater compliance with treatment [12].
the time of primary diagnosis. Mean patient age at However, no published data are available concerning registration was 54.5 years (SD 9.7; range 24–72).
the relationship between informed consent and quality We estimated the duration of survival from the time of registration to either death or the date of the last In this study, we tried to answer the initial question from the viewpoint of psycho-oncology. We used datafrom a multi-institutional, prospective, randomized phase III trial conducted by the Japan cooperative on-cology group (JCOG). Our objective was to investigate The chi-square test, Fisher’s exact probability test, or the effect of patients’ understanding of their disease t-test was used for comparing the characteristics of on their survival after being informed by their physi- patients and tumors. Survival rates were calculated us- cian. All the patients had metastatic breast cancer and ing the Kaplan–Meier method [18]. All deaths were counted, regardless of their cause. Each patient wasconsidered alive at the time of her last evaluationunless death had been documented. The stratified log-rank test was used for comparison of survival curves, Patients and methods
and censored data were taken into account [19]. Bothunivariate and multivariate analyses were used for the Women with metastatic breast cancer who particip- analysis of potential prognostic factors. All factors ated in a multi-institutional, randomized clinical trial other than age were dichotomized and coded as 0 (JCOG study 8808) were studied. This trial consisted (reference level) or 1. Age was evaluated as a continu- of two therapy regimens to allow comparison of hor- ous variable. For determination of the most significant monal agents: ACT (doxorubicin, cyclophosphamide, variables contributing to survival, the Cox propor- tamoxifen) and ACM (doxorubicin, cyclophospham- tional hazards model was applied [20]. Differences ide, medroxyprogesterone) [17]. Patients were ran- with a P value of less than 0.05 were considered domly assigned to receive either of the regimens, and significant. All P values were two-sided. Analyses were recruited between December 1988 and Decem- of prognostic factors in this patient population are ber 1991; 218 patients agreed to participate. Patients reported in detail elsewhere [21]. All data analyses with severe mental disorders or cognitive impairment used SPSS Version 6.1 statistical software (SPSS Inc., Before the initial treatment, the patients were asked in writing ‘To what extent do you understand yourown disease after being informed by your physician during the explanation of the clinical trial?’ Two hun-dred and fourteen women (98.2%) replied. Responses Patients’ classification and characteristics were graded 1 (understand well), 2 (understand tosome extent), 3 (understand only a little), 4 (do not Ninety-five patients (44.4%) understood well, 95 un- understand well), or 5 (do not understand at all). After derstood to some extent, 18 (8.4%) understood only a the first cycle of treatment, we asked the question little, 3 (1.4%) did not understand well, and 3 did not understand at all. Their median survival times were For all patients, with permission of the JCOG data 28.3, 28.5, 20.9, 10.5 and 10.0 months, respectively.
center, we gathered data from case report forms on From this result, we thought it was appropriate to Patients’ understanding and survival potential Table 1. Distribution of selected characteristics in patients among ‘better under-standing’ group and ‘poor understanding’ group ∗Chi-square test, Fisher’s exact probability test, or t-test (age).
Table 2. Comparison os survival classified into two groups according to their understanding of their disease: ‘betterunderstanding group’ and ‘poor understanding group’ Abbreviation: MST, median survival time.
consider patients in the first two groups together, andcompare them with the patients in the last three groupscombined. Therefore, 190 patients (89%) formed the‘better understanding’ group and 24 patients (11%)formed the ‘poor understanding’ group.
Table 1 summarizes the characteristics of patients and tumors. There were no significant differences inany factors between the two groups. At the time ofanalysis, the median follow-up time was 25.5 months(range 0.9–97.1). For the 30 censored patients stillalive, the median follow-up time was 79.9 months Figure 1. Comparative survival curves of patients classified accord- ing to their understanding of their disease: ‘better understanding’group and ‘poor understanding’ group. P values were calculated by Follow-up data regarding patients’ understanding When the question was repeated after the first cycle of (p = 0.033), serum aspartate aminotransferase (AST) treatment, only 10 patients (4.6%) gave answers that (p < 0.01), serum alanine aminotransferase (ALT) were different to those before treatment: four from (p < 0.01), serum alkaline phosphatase (ALP) (p < poor understanding to better understanding, and six 0.01), serum carcinoembryonic antigen (CEA) (p = from better understanding to poor understanding.
0.02), and serum CA15-3 (p < 0.01), as well as pa-tient understanding. Based on these significant factors Comparison of survival between the two groups and on adjuvant chemotherapy, which is an important Table 2 lists survival rates from 1 to 5 years and prognostic factor for patients with metastatic breast the median survival times. The median survival times cancer, multivariate regression analyses using the Cox were 28.3 months for the ‘better understanding’ group proportional hazard model were conducted to identify (95% CI 22.3–34.3), and 16.1 months for the ‘poor factors that independently had the most important understanding’ group (95% CI, 8.1–24.0). The ‘poor prognostic influence on survival. Stepwise regression understanding’ group also showed a significantly dif- procedures were applied to calculate the values of the ferent overall survival from the ‘better understanding’ beta-coefficients of the Cox model. After adjustment group (p = 0.016) (Figure 1).
for age, which is suggested to be associated with pa-tients’ understanding, patients who did not understand Univariate and multivariate analyses still had poorer survival than those who understood(hazard ratio = 2.09; 95% CI, 1.16–3.78; p = 0.014) Univariate analysis of pretreatment characteristics of patients and tumors revealed significant prognostic in-fluences for DFI (p < 0.01), PS (p < 0.01), distantlymph nodes metastasis (p = 0.032), liver metastasis Discussion
(p < 0.01), number of metastatic sites (p = 0.029),hemoglobin (Hb) (p = 0.025), serum lactic dehyd- Informed consent is the basic component of all cancer rogenase (LDH) (p < 0.01), serum total protein (TP) care and is considered an essential psychosocial, be- Patients’ understanding and survival potential Table 3. Multivaliate survival analysis using Cox’s proportional hazard model ∗The lower range of each category is the reference category.
havioral, and ethical aspect of cancer treatment. The the hospital, resulting in greater treatment compli- present study showed that patients who reported that ance. However, treatment compliance with the clinical they did not understand their disease after being in- trial was not apparent in this study. The relative dose formed by their physician during the explanation of intensity of doxorubicin (intravenous) was approxim- the clinical trial had poorer survival than patients who ately 90% in both treatment arms, and the patients reported that they understood. As there were no dif- were asked at each clinic visit whether they had swal- ferences in medical factors between the two groups lowed the prescribed drugs. However, no records were classified according to patients’ understanding, some available. Therefore, although these explanations are other factor such as psychosocial or behavioral factor still highly speculative and further studies are needed, might have contributed to their survival.
our findings support the supposition that it is import- Considering the previous reports on the relation- ant to evaluate patients’ understanding of information, ship between psychosocial or behavioral factors and even after their consent has been obtained.
survival, there are a number of possible reasons why The major limitations of this study were the use patients who do not understand their disease have of only a single item for measuring patients’ under- higher mortality from cancer. One possibility is related standing of their disease and the lack of measurement to social support from physicians [7, 9, 16]. Patients of other variables that might have helped to explain who do not understand their disease may not be able the link between understanding and survival. It is un- to talk honestly with their physician in order to solve clear why 24 patients (11%) reported that they did not problems, develop an attitude of partnership with the understand their disease, although they were all able physician, and consequently receive better support.
to read, speak, and communicate in Japanese. It is Another possibility is related to patients’ coping or unlikely that these patients were unable to understand behavior [7, 12]. Understanding the nature and course due to mental problems, because the eligibility cri- of the disease may change patients’ behavior, that is, teria for this clinical trial excluded patients with severe patients who understand their disease may acquire bet- mental disorders or cognitive impairment. Education ter health habits and self-care and regularly consult level, which was not evaluated in this study, may be an important factor in explaining the reason for differ- Fawzy FI, Fawzy NW, Hyun CS, Elashoff R, Guthrie D, ences in patients’ understanding of their disease [22, Fahey JL, Morton DL: Malignant melanoma. Effects of anearly structured psychiatric intervention, coping, and affect- 23]. However, there were no illiterate patients, among ive state on recurrence and survival 6 years later. Arch Gen whom the survival rate was reported to be lower than that among patients who had more than 12 years of House JS, Landis KR, Umberson D: Social relationships and education [24]. It is possible that the patients may not Spiegel D: Psychosocial intervention in cancer. J Natl Cancer have wanted to understand the bad news. Furthermore, the patients may not have understood on only one oc- Richardson JL, Shelton DR, Krailo M, Levine AM: The ef- casion, or sufficient information may not have been fect of compliance with treatment on survival among patients with hematologic malignancies. J Clin Oncol 8: 356–364,1990 In conclusion, this study had some limitations due Slevin ML, Nichols SE, Downer SM, Wilson P, Lister TA, to the retrospective analysis employed. However, it Arnott S, et al.: Emotional support for cancer patients: seems that the present results include important find- What do patients really want? Br J Cancer 74: 1275–1279, ings regarding the relationship between patients’ un- Bloom JR: Social support, accommodation to stress and derstanding of their disease after giving their informed adjustment to breast cancer. Soc Sci Med 16: 1329–1338, consent and length of survival. Therefore, it would be worthwhile to investigate this relationship further.
Akechi T, Okamura H, Yamawaki S, Uchitomi: Predictorsof patients’ mental adjustment to cancer: patient charac-teristics and social support. Br J Cancer 77: 2381–2385,1998 Acknowledgements
Watson M, Greer S, Young J, Inayat Q, Burgess C, RobertsonB: Development of a questionnaire measure of adjustment to We thank Ms. Ryoko Katayama, at the Psycho- cancer: the MAC scale. Psychol Med 203–209, 1988 Watanabe T, Adachi I, Tajima K, Aoyama H, Sano M, Oncology Division, National Cancer Center Research Nomura Y: Improving the quality of life during chemoen- Institute East, Japan, for her research assistance. This docrine therapy for metastatic breast cancer: A randomized study was supported in part by a grant-in-aid for comparison of tamoxifen (TAM) versus medroxyprogesteroneacetate (MPA) in combination with doxorubicin (ADM) plus cancer research and the second-term comprehensive cyclophosphamide (CPA) (Abstract). Proc Am Soc Clin Oncol 10-year strategy for cancer control from the ministry Kaplan EL, Meier P: Nonparametric estimation from incom-plete observation. J Am Stat Assoc 53: 457-481, 1958 Mantel N: Evaluation of survival data and two new rank orderstatistics arising in its consideration. Cancer Chemother Rep References
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