We are very grateful to all of the patients who participated in the study. We especially thank the Institute Paoli-Calmettes patients' committee, the administrative assistants, and all of the health care professionals who were involved in this study.
Information is crucial for increasing the patients' empowerment and autonomy in relevant decision-making processes, especially in malignant diseases. However, the extent to which information should be delivered is debated. The objective of this study was to assess the impact of providing systematic full access (SFA) to the medical record on anxiety, quality of life, and satisfaction.
Patients with newly diagnosed breast cancer, colon cancer, or lymphoma who had received adjuvant chemotherapy in an outpatient setting were included in a randomized controlled trial comparing those who requested access (RA) and those who provided SFA to the medical record. Anxiety was assessed using the Spielberger State-Trait Anxiety Inventory before, during, and at the end of treatment. Quality of life was evaluated using the European Organization for Research and Cancer quality-of-life questionnaire (EORTC QLQ-C30) before and at the end of treatment. Patients' satisfaction and perception of the organized medical record (OMR) were evaluated using a specifically designed questionnaire at the end of treatment.
Most patients (98%) who had the opportunity to obtain the OMR chose to do so. Anxiety levels did not increase in the SFA arm, although they did not differ significantly compared with anxiety levels in the RA arm. The patients who had full access to their medical record were more satisfied with information (odds ratio, 1.68; 95% confidence interval, 0.98-2.9) and felt sufficiently informed more often (odds ratio, 1.86; 95% confidence interval, 1.08-3.19), but the differences were not statistically significant at the 5% level.
Patients' autonomy and empowerment, which are now considered the ethical gold standard in industrialized countries, require access to information as a prerequisite. 1-5 After a diagnosis of malignant disease, missing or insufficient information concerning the disease and its prognosis, the therapeutic options, and their side effects can significantly impair the patient's quality of life. There is evidence in the literature that the majority of cancer patients would like to receive as much information as possible from their physicians. 5, 6-11 Indeed, detailed information on the disease is important for the patient to make informed decisions regarding treatment options. 5 It also allows the patient and his or her family to cope better with the disease and its implications. 8
Information can be provided from physicians and medical staff to patients in different ways, but the most is verbal communication. However, the quality of this form of interaction is limited by the lack of time for a comprehensive discussion, semantic problems between physicians and patients, and the inability of the patient to recall all the information provided during a single visit. 12, 13 It has been demonstrated that patients remember 50% to 60% of the information provided during any conversation they have with their physicians. 14 Therefore, information needs to be repeated and shared in different forms, either written or audiovisual. The added benefit is that the patient can repeatedly read the documentation at home and share it with family members and other treating physicians or nurses. 15, 16 Moreover, providing detailed information in either of the these forms may result in more active participation in treatment decision-making among cancer patients. 17-21
Cultural and social patient-physician variables determine the communication style. Currently, the practice of nondisclosure generally is considered outdated, and physicians have an ethical and legal duty to disclose relevant information to patients. 3 A law was approved in France in March 2002 stating that, upon request, patients can have unrestricted, direct access to their medical records (previously the request could be made only by a physician). 3
Despite important legal and ethical advances in this area and the growing interest in providing patients with greater access to their medical records, the impact of these new practices remains unknown; in particular: Do they make the patient feel better? Is it possible and desirable to disclose everything? Therefore, the main objective of the current study was to evaluate the consequences of providing comprehensive information about disease through an organized medical record (OMR), as measured by anxiety levels. In addition, we assessed the impact on quality of life and the patient's satisfaction with the OMR.
MATERIALS AND METHODS
The study was conducted at the Paoli-Calmettes Institute Regional Comprehensive Cancer Center (Marseille, France). It was reviewed and approved by the local patients' committee and the institutional review board.
All patients with newly diagnosed with breast cancer, colon cancer, Hodgkin lymphoma, and non-Hodgkin lymphoma (ie, the most frequent pathologies in the outpatient setting at our institute) were eligible if they were to receive adjuvant chemotherapy in an outpatient setting. To be included, patients had to fulfill the following inclusion criteria: age ≥18 years, no history of previous chemotherapy, all cycles of adjuvant chemotherapy to be administered at our institute, a Karnofsky performance status >70%, good understanding of oral and written French, and the ability to provide written informed consent.
Eligible patients were invited to participate in the study during the initial consultation, after information about the extent of their disease and treatment plan had been delivered. After a brief description of the study and upon agreement, potential participants received a detailed letter explaining the purpose and implications of the study. This letter also ensured the confidentiality of their data and underlined the finding that neither their consent nor their refusal to participate would influence the future quality of care received or restrict standard access to their medical records. Patients were required to provide written informed consent before entry into the study. Randomization was performed on the day of the first chemotherapy course. Patients were assigned to the “requested access” (RA) arm (ie, information and medical record delivered at the physician's initiative or upon the patient's request, which is the usual information management policy), and the OMR arm. In the latter arm, patients had the opportunity either to accept the OMR (patients who did were included in the systematic full access [SFA] arm) or to refuse it.
Content of the OMR
The OMR was intended to provide patients with comprehensive information about their disease and treatment. It consisted of a briefcase that the patient was advised to bring to each visit. This briefcase included administrative data as well as the following reports: surgery, pathology, hospitalizations, nurse narratives, radiology and biologic reports, as well as overall medical and paramedical information concerning the patient's treatment. The documents (sheets, imaging radiology, or compact discs) were given to the patient by the medical coordinator, who also provided explanations. Of course, the medical staff and nurses also provided the patient with information, although it was not standardized. A medical lexicon and a user guide also were provided to the patient, who also was helped by the physician and a paramedical coordinator in the handling and understanding of the various documents that were included in the dossier. The OMR was to be updated at each visit, and additional information could be mailed to the patient if appropriate. Thus, the patients obtained medical information in real time during the study.
Sociodemographic data were collected for all patients at the baseline visit. All questionnaires were self-administered by the patients and were distributed during appropriate visits, except for the end-of-treatment questionnaires (satisfaction with the process of care and perception of OMR), which was mailed to the patients at the end of the study.
Anxiety levels were assessed using the French version of the Spielberger State-Trait Anxiety Inventory. 22 This instrument measures both the patient's generic anxiety profile (trait anxiety, 20 items) and anxiety when confronted with a specific situation (state anxiety, 20 items). 15, 23-25 A higher score (range, 20-80) indicates a higher level of anxiety. For all patients, state-anxiety levels were evaluated before (T0), during (T1), and at the end (T2) of chemotherapy. The T1 evaluation took place on the first day of the fourth chemotherapy course for patients with lymphoma and breast cancer and on the first day of the seventh chemotherapy course for patients with colon cancer.
Quality of life was evaluated using the French version of the European Organization for Research and Treatment of Cancer (EORTC) core quality-of-life questionnaire (QLQ-C30) 26-28 at the time of enrolment and at the end of treatment. Patient's satisfaction with the process of care was evaluated by a specifically designed questionnaire at the end of treatment. Variables were measured using a 4-point Likert scale (with 4 responses that ranged from not at all to completely). The questions related to treatment explanations, relationships with medical staff, treatment implementation, and coordination between all medical specialists. The patients were also asked whether they felt sufficiently informed.
Patient's perceptions of the OMR were assessed at the end of treatment in the SFA group only. Patients indicated whether they had read the information, whether they understood it, and whether it was rather helpful or anxiety provoking. All items were assessed using a 4-item Likert scale (with 4 responses: not at all, slightly, moderately, completely).
Data analysis was carried out using the software Statistical Package for Social Sciences (version 11; SPSS, Inc., Chicago, Ill). The primary endpoint was the difference in the anxiety scores between patients who had full access to their medical files (SFA arm) and patients who underwent a standard information management (RA arm), as measured at T1 and T2. The mean Spielberger anxiety score reported in the literature for patients with cancer is 40. 15 On the basis of the hypothesis that full access to medical records would result in a decrease in anxiety scores of at least 11 points (considered clinically relevant), and using 2-sided tests with a 5% type I error and 90% power, the total number of patients to be analyzed in the current study was 248. Comparisons between anxiety scores at T0, T1, and T2 within each group also were performed.
For the univariate analysis, we used 2-sided chi-square tests and analyses of variance for qualitative data and Student t tests or the Mann-Whitney nonparametric test for continuous data, according to the Komolgorov-Smirnoff test of normality. With regard to questions about patient satisfaction with the process of care, the “not at all,” “slightly,” and “moderately” categories were combined and compared with the “completely” category. Concerning the perception of the OMR, the “not at all” and “slightly” items were compared with the “moderately” and “completely” items.
Two logistic regression models were performed to detect factors that predicted the odds of being completely satisfied with the explanations given during the treatment as well as the odds of feeling fully informed. To select statistically significant factors, the usual stepwise procedure was used (exclusion threshold, P > .1). We used the Hosmer-Lemeshow test to determine the goodness of fit of the model.
Between November 2003 and June 2006, 350 patients met the selection criteria. Only 14 patients (4%) refused to participate, and the remaining 336 patients were randomized: There were 169 patients (50.3%) in the RA arm and 167 patients in the OMR arm. In the latter arm, 163 patients (97.6%) chose to receive the OMR (and then were placed in the SFA arm), and there were only 4 refusals. Thirty-seven patients were excluded from the analysis because they did not return the baseline questionnaire (14 patients in the SFA arm and 23 patients in the RA arm). Because of the small number of patients who refused the OMR, these patients were excluded from the analysis (there was no difference in terms of sociodemographic characteristics). The disposition of patients is displayed in Figure 1.
Two hundred ninety-five patients were analyzed (149 in the SFA arm and 146 in the RA arm). No statistical difference was observed between the 2 groups in terms of tumor type, age, marital status, or education (Table 1). The mean patient age was 54.6 years (±12.1 years), and there were 39 men (13.2%) and 256 women (86.8%). Most patients had breast cancer (75.6%), 15.3% had lymphoma, and 9.2% had colon cancer.
Table 1. Patients' Characteristics at Randomization (N=295)
No. of Patients (%)
All Patients, N=295
SFA indicates systemic full access; RA, requested access; NS, nonsignificant; SD, standard deviation.
Age: Mean±SD, y
Married or cohabiting
No diploma/primary school
Type of tumor
The mean anxiety score was 40.7 ± 11.7 before treatment and was similar in both groups. This score remained very stable during treatment. No significant differences were observed between the RA and SFA arms regardless of the time of evaluation (Table 2). However, patients in the RA arm experienced a significant reduction in anxiety levels between T1 and T2 (41.6 vs 38.9; P < .05)
Table 2. Anxiety Levels in All Patients and in the Systemic Full Access and Requested Access Groups Before, During, and at the End of Chemotherapy
Mean±SD Anxiety Level
SD indicates standard deviation; T0, before chemotherapy; T1, during chemotherapy; T2, at the end of chemotherapy; NS, nonsignificant; SFA, systemic full access; RA, requested access.
Quality of Life
No difference was observed in global quality-of-life scores between the RA and SFA arms either before treatment (63.5 ± 19.8 vs 65.3 ± 19.3, respectively) or at the end of treatment (60.3 ± 19.6 vs 60.3 ± 18.3, respectively). This result applied to all the items or groups of items.
Satisfaction With the Care Process in the Whole Population
Results from the univariate analyses on patients' satisfaction (Table 3) indicated that more patients in the SFA arm were completely satisfied with treatment explanations (65.6% vs 54.9% in the RA arm), although the difference did not reach statistical significance (P = .111). Similarly, a higher percentage of patients in the SFA arm believed that they were fully informed (65.3% vs 53.5% in the RA arm; P = .066). It is worth noting that patients were slightly more satisfied with the coordination between specialists in the SFA arm (69.8% vs 78.6% in the RA arm; P = .14).
Table 3. Global Satisfaction in the Systemic Full Access and Requested Access Groups (Completely Satisfied vs Not at All/A Little/Slightly Satisfied), N=239
Percentage of Patients
SFA indicates systemic full access; RA, requested access; NS, nonsignificant.
Completely satisfied with explanations about treatment
Completely satisfied with relationships with the medical team
Completely satisfied with the implementation of treatment
Completely satisfied with the coordination between specialists
Feeling completely well informed
The multivariate analyses could not identify any factor that was associated with complete satisfaction with the treatment explanations at the 5% level; a significant correlation was observed at the 10% level for the SFA arm (increased satisfaction: odds ratio [OR], 1.68; 95% confidence interval [CI], 0.98-2.90), higher educational levels (decreased satisfaction: OR, 0.60; 95% CI, 0.35-1.04), and professional activity (decreased satisfaction: OR, 0.58; 95% CI, 0.32-1.04). Those results are displayed in Table 4. Covariates that were associated with the feeling of being fully informed were randomization to the SFA arm (OR, 1.86; 95% CI, 1.08; 3.19) and age (OR, 1.03; 95% CI, 1.01-1.05) (Table 5). Because of missing data on some questionnaires, only 239 patients are analyzed in Tables 3, 4, and 5.
Table 4. Multivariate Analysis of Determinants of Patient's Satisfaction With Explanations About Treatment (N=239)a
OR indicates odds ratio; CI, confidence interval.
Variables that were entered in the model included arm, tumor, age, sex, couple, having children, having a professional occupation, higher education level (baccalaureate or greater). The Hosmer-Lemeshow goodness-of-fit statistic was 2.961 (with 6 degrees of freedom; P = .814). The predictive power of the model was 63.7% with adjustment for the number of variables in the model.
Systematic full access arm
Having a professional occupation
Higher educational level
Table 5. Multivariate Analysis of Determinants of Patients Sense of Being Completely Well Informed (N=239)a
OR indicates odds ratio; CI, confidence interval.
Variables that were entered in the model included arm, tumor, age, sex, couple, having children, having a professional occupation, higher education level (baccalaureate or greater). The Hosmer-Lemeshow goodness-of-fit statistic was 4.946 (with 8 degrees of freedom; P = .763). The predictive power of the model was 61.5% with adjustment for the number of variables in the model.
Systematic full access arm
Perception of the OMR in the SFA Arm
First, 70.4% of patients in the SFA arm declared that, with hindsight, they would choose again to receive the OMR; and, quite logically, 74.8% did not regret their choice. In addition, 76.3% of the patients in the SFA arm stated that they checked the OMR, and 76.3% considered that it met their expectations. Moreover, 81.5% of all patients in the SFA arm were globally satisfied with the OMR, and 60% did not find the OMR briefcase heavy or cumbersome (Table 6).
Table 6. Patients' Perceptions of the Organized Medical Record in the Systemic Full Access Group Only (N=135)
OMR Perception Questions
OMR indicates organized medical record; GP, general practitioner.
With hindsight, would you choose again to get the OMR?
Moderately to completely
Have you checked the OMR?
Did the OMR correspond to your expectations?
Globally, would you say that you are satisfied with the OMR?
Was the instruction for use clear enough
Have you understood the information included in the OMR?
Has the OMR helped you to better understand your disease?
Has the OMR helped you to better discuss your disease with your relatives?
Has the OMR helped you to better discuss your disease with your GP?
Has the OMR helped you better discuss your disease with the oncologists?
Has the OMR helped you for being actor of your own care
Has the OMR helped you to be involved in the medical decision process
Not at all or a little
Was the OMR a source of anxiety?
Did you regret to have checked your OMR?
Is there any information in the OMR that you preferred to ignore?
Have you sometimes forgotten your OMR?
Was the briefcase heavy or cumbersome?
Second, 68.8% of patients declared that the OMR had not been a source of anxiety for them, 82.2% understood the information enclosed, and the majority (77%) did not discover any unwanted information in the OMR. Finally, the OMR not only allowed patients to understand their disease more thoroughly (71.1%) but also helped them discuss it with their relatives (59.2%), their general practitioner (56.3%), and their oncologist (62.3%). OMR availability also helped patients to be involved in the medical decision-making process (60%) and to become empowered (63%). All of the percentages provided above were calculated from the total number of patients in the SFA arm, and not only from those who checked the OMR.
Forty-nine patients from the SFA arm made comments, and 15 of them also included some negative concerns. Three patients complained that the briefcase was too heavy, and 1 patient said that its color was inadequate. Three patients stated that it was difficult to classify information, and 2 said that the time for document collection had been too long. Finally, 6 patients wanted more information.
It has been demonstrated that providing accurate information to patients with cancer reduces their emotional distress and enhances their ability to care for themselves and carry on with daily activities. 29, 30 Patients are more satisfied when information comes from health care professionals than when they find it through formal support services or through print and electronic media. 31, 32 However, to our knowledge, no data have been published regarding the impact of changes in information supply, whether qualitative or quantitative, on the patient's psychological status. Therefore, we conducted this randomized controlled trial to test the hypothesis that anxiety decreases in patients who are given full access to medical information. Patients with newly diagnosed cancer were assigned randomly to the RA arm (usual care) or the SFA arm, which gave them the opportunity to receive a personal, updated medical record. The large majority of patients (97.6%) in this SFA arm chose to have access to the OMR, which indicates that patients are very eager to get as much information as possible. The primary endpoint in this study was the Spielberger State-Trait Anxiety Inventory score. Actually, anxiety levels remained similar in both arms during and at the end of treatment, and we failed to demonstrate a benefit of SFA on anxiety. It could be argued that having access to the OMR does not necessarily mean reading it, but 76.3% of patients in the SFA arm said that they did red it, and 80% reported a good understanding of the OMR.
With regard to patients in the RA arm, a significant decrease in anxiety levels was observed between the intermediate and final evaluations. It is possible to hypothesize that this may have been because of lower information levels about what could happen after the end of chemotherapy and potential relapse. Consequently, it would be interesting to evaluate the anxiety level later during the course of the disease, after the end of treatment, to study the evolution of anxiety in both groups in the middle and long terms. This could be carried out in future studies.
SFA to the OMR, as expected, helped patients to gain a better understanding of their disease and to communicate with their relatives (59%) or their oncologist (62%). Patients also considered that the OMR helped them to participate in the medical decision-making process (60%). However, higher percentages were expected. A relatively low proportion of patients stated that the OMR was helpful in their communication with their general practitioner (56%). This result is consistent with the lower proportion of patients who were completely satisfied with the coordination between specialists in the SFA arm compared with the RA arm (70% vs 79%; nonsignificant difference). It also could be argued that patients in the SFA arm expected better coordination because of the implementation of this process based on transparency. In the SFA arm, 31.2% of patients reported that the OMR had increased their anxiety. Moreover, 25.2% had regrets about accepting it. Thus, it is likely that comprehensive medical information is appropriate and possibly beneficial for some patients but not all, and it may be relevant to identify the characteristics of those patients who experienced anxiety and/or regrets and to determine which patients are and are not suited for comprehensive information.
Previous studies reported that age, sex, and educational level were associated with preferred communication styles. 33 In the current study, we did not identify any significant factor that predicted satisfaction with information, whereas age and randomization to the SFA arm had only weak associations with feeling fully informed.
Having information in written form but consulting it only if desired represents 1 of the advantages of the OMR. Providing complete information to patients may increase trust in their physician and the medical team. 34 The finding that OMR did not increase anxiety levels defeats 1 of the arguments used by some physicians to explain why it is not possible or suitable to give exhaustive information to patients. The OMR does not make the oral transmission of medical information redundant but can be viewed as complementary.
It has been demonstrated that satisfaction with information is an important patient outcome: Patients who are satisfied with information experience better psychosocial outcomes, including less mood disturbances, fewer depressive symptoms, and lower levels of anxiety. They also are more likely to comply with medical recommendations and treatments. 35 However, information that is considered irrelevant by physicians and, consequently, is concealed may be perceived as useful and appropriate by patients. Furthermore, with increasing distrust toward health care professional and institutions, lack of disclosure could be interpreted as a willingness to hide something important. 36 Moreover, generalization of SFA to the OMR may help patients avoid unnecessary or repetitive tests and examinations by enhancing information flow between different medical specialists or institutions, which should be of great interest in situations like cancer treatment that involve multidisciplinary management.
The current study had limitations. First, the study population included mainly young women (mean age, 55 years) in early stages of cancer with a rather good prognosis. The levels of anxiety and the potential impact of providing comprehensive medical information probably would have been different in older patients with metastatic, late-stage disease. 37 Thus, our results cannot be extrapolated to the general population of cancer patients. The second limitation stems from implementation of the study in a high-level, dedicated oncology department, in which every effort is made to help patients gain to access to information. In this type of institution, the “usual care” provides patients with as much information as possible, so that the difference may have been low between the 2 groups. Another limitation was the time of OMR delivery, after the therapeutic strategy had been decided; there is not much to be discovered in the OMR at this stage and during the first line treatment. Finally, oral communication with the patient was not standardized, which may have had an impact on anxiety levels. It may have been interesting to measure depression or to introduce a qualitative approach. This should be done in further research.
In conclusion, providing an OMR to patients is easy to implement in routine medical practice. Our study demonstrated that, in practice, this change was very attractive for patients, because 98% of the patients who had the opportunity to obtain the OMR chose to do so. The information enclosed was understood, or at least was considered understood, by 82% of the patients. Having full access to medical record neither decreased nor increased anxiety, and patients were globally satisfied with the OMR, which helped them to improve their understanding of the disease and eased communication with physicians and family members.
However, further evaluations need to be carried out on larger cohorts in a multicenter setting, including all types of cancers and in the context of more advanced disease. Moreover, future studies need to be implemented in the context of the electronic medical file, which provides patients with secured, direct access to their records, even from home. This would avoid both documents classification and time for collection issues.
The study was funded by the French Ministry of Health (PHRC no. 24-36)