Self-reported cognitive functioning in postmenopausal breast cancer patients before and during endocrine treatment: findings from the neuropsychological TEAM side-study.

OBJECTIVE: This study aimed to evaluate self-reported cognitive functioning of postmenopausal breast cancer patients before and during endocrine treatment compared with healthy female controls, and to investigate associations between self-reported cognitive functioning, cognitive test performance and anxiety/depression, fatigue, and menopausal complaints. METHODS: Self-reported cognitive functioning, anxiety/depression, fatigue, menopausal complaints, and cognitive tests performance were assessed before (T1) and after 1 year (T2) of adjuvant endocrine treatment in postmenopausal chemotherapy-naïve breast cancer patients. Self-reported cognitive functioning was assessed by the cognitive failures questionnaire and interview questions concerning cognitive complaints. Patients participated in the TEAM-trial, a prospective randomized study investigating tamoxifen versus exemestane as adjuvant therapy for hormone-sensitive breast cancer. Identical information was obtained from healthy postmenopausal volunteers. RESULTS: Two measures for self-reported cognitive functioning provided the distinctive results. At T1 and T2, healthy controls reported a higher frequency of cognitive failures than patients; change over time did not differ between groups. The prevalence of cognitive complaints did not differ between the groups at T1, but change over time regarding attention/concentration complaints differed between groups, due to an increased prevalence in tamoxifen users. Self-reported cognitive functioning showed moderate associations with anxiety/depression, fatigue, and menopausal complaints. Cognitive test performance was not associated with self-reported cognitive functioning, but weakly with anxiety/depression and fatigue. CONCLUSION: Adjuvant therapy with tamoxifen and exemestane did not influence the self-reported frequency of cognitive failures. Increased attention/concentration complaints were observed in tamoxifen users, but not in exemestane users. This latter finding should be confirmed with better validated instruments.

[The effect of hormone therapy on cognitive function in patients with breast cancer]. / De invloed van hormonale therapie op het cognitieffunctioneren van patiënten met het mammacarcinoom.

Preclinical and clinical studies suggest that oestrogens have an important role in brain functioning and cognitive ability. Given that hormone therapies for breast cancer reduce oestrogen levels or block oestrogen receptors, it is conceivable that these agents also influence cognitive function. Several small studies have been conducted to address this issue, but many of them are methodologically insufficient. The negative effects of oophorectomy and luteinising hormone-releasing hormone (LHRH) analogues on verbal memory and working memory have been demonstrated the most consistently, albeit only in small studies. Anastrozole and tamoxifen also appear to exert some negative effect on cognition, but well-designed studies are lacking. No data are available on the influence of the aromatase inhibitors exemestane and letrozole on cognitive function. Raloxifene, a drug that has no obvious advantages over tamoxifen and will likely not be developed further for breast cancer treatment, has no negative influence on cognitive functioning. It remains unclear whether the observed effects are transient or permanent, and to what extent age, menopausal status and duration of therapy influence the severity of cognitive effects.

Impairment of cognitive function in women receiving adjuvant treatment for high-risk breast cancer: high-dose versus standard-dose chemotherapy.

BACKGROUND: Although high-dose chemotherapy is rapidly gaining acceptance as a treatment option for a number of cancers, the long-term toxic effects of such therapy are a concern. Cognitive deficits (e.g., problems with memory and concentration) are not uncommon after chemotherapy, but they have not been documented systematically. In this study, we assessed the prevalence of cognitive deficits in a group of patients with high-risk breast cancer who were randomly assigned to receive either high-dose or standard-dose adjuvant chemotherapy plus tamoxifen, and we investigated whether high-dose chemotherapy impaired cognitive functioning more than standard-dose chemotherapy. METHODS: Cognitive functioning was evaluated by use of a battery of neuropsychologic tests. In addition, patients were interviewed with regard to cognitive problems, health-related quality of life, anxiety, and depression. Results from patients who received adjuvant systemic therapy were compared with results from patients who had early stage breast cancer not treated with such therapy (control patients). RESULTS: The study population consisted of 34 patients treated with high-dose chemotherapy plus tamoxifen, 36 patients treated with standard-dose chemotherapy plus tamoxifen, and 34 control patients. For all patients, the average time since the completion of last nonhormonal therapy was 2 years. Cognitive impairment was found in 32% of the patients treated with high-dose chemotherapy, in 17% of the patients treated with standard-dose chemotherapy, and in 9% of the control patients. In comparison with the control patients, patients treated with high-dose chemotherapy appeared to have an 8.2-times higher risk of cognitive impairment (odds ratio; 95% confidence interval [CI] = 1.8-37.7); in comparison with the patients who received standard-dose chemotherapy, this risk of impairment was 3.5-times higher (95% CI = 1.0-12.8). CONCLUSION: High-dose chemotherapy appears to impair cognitive functioning more than standard-dose chemotherapy. Central nervous system toxicity may be a dose-limiting factor in high-dose chemotherapy regimens.

[Severe disciplinary measures in the Millecam case: important precedent for revising the rules of conduct by scientific associations and the KNMG]. / Strenge tuchtrechtelijke maatregelen in de zaak-Millecam: belangrijke jurisprudentie voor het aanscherpen van de gedragsregels door de wetenschappelijke verenigingen en de KNMG.

The popular 45-year-old Dutch actress Sylvia Millecam died in August 2001 from untreated advanced breast cancer. She refused standard medical treatment and sought solace in many alternative healers, including three medical physicians. The Dutch Healthcare Inspection accused the three physicians of malpractice and asked the Medical Disciplinary Tribunal to pass judgment. In April 2006 one physician was struck from the physician register and the other two were suspended for 1 year and 6 months, respectively. These unusually severe measures were based mainly on the fact that they had neglected professional standards as defined by specialty boards, they had presented themselves as professional physicians and they had not tried hard enough to convince Millecam of the need for standard treatment. The Tribunal did not accept the strong desire of the patient to undergo only alternative treatment as a defence. Notably, the judgment of the Tribunal seems to be more severe than the present bylaws of medical-scientific bodies and the Dutch Medical Association (KNMG), which are apparently too lenient regarding the use of alternative treatments by their members.

Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials.

PURPOSE: Here we report the results of a randomized study undertaken to test the efficacy of a supplementary, telephone-based nursing intervention in increasing patients' awareness and understanding of the clinical trials in which they are asked to participate. METHODS: During a 12-month period, 180 cancer patients who were approached to participate in a phase II or III clinical trial were randomized to undergo either of the following: (1) standard informed consent procedures based on verbal explanations from the treating physician plus written information (controls); or (2) standard informed consent procedures plus a supplementary, telephone-based contact with an oncology nurse (intervention). For purposes of evaluation, face-to-face interviews were conducted with all patients approximately 1 week after the informed consent process had been completed. RESULTS: The two groups were comparable with regard to sociodemographic and clinical variables. Both groups had a high level of awareness of the diagnosis and of the nature and objectives of the proposed treatments. The intervention group was significantly (P < .01) better informed about the following: (1) the risks and side effects of treatment; (2) the clinical trial context of the treatment; (3) the objectives of the clinical trial; (4) where relevant, the use of randomization in allocating treatment; (5) the availability of alternative treatments; (6) the voluntary nature of participation; and (7) the right to withdraw from the clinical trial. The intervention did not have any significant effect on patients' anxiety levels or on rates of clinical trial participation. Patients reported high levels of satisfaction with the intervention. CONCLUSION: The use of a supplementary, telephone-based nursing intervention is a feasible and effective means to increase cancer patients' awareness and understanding of the salient issues that surround the clinical trials in which they are asked to participate.

Longitudinal study on the Quality of Life of symptomatic HIV-infected patients in a trial of zidovudine versus zidovudine and interferon-alpha.

OBJECTIVES: To compare the effect of treatment with zidovudine (ZDV) or a combination of ZDV and interferon-alpha (IFN-alpha) on patient Quality-of-Life (QoL); and to document changes over time in QoL. DESIGN: This study is part of a longitudinal, randomized, controlled clinical trial comparing the efficacy and tolerance of ZDV monotherapy and ZDV plus IFN-alpha. Patients were followed-up for 1 year. SETTING: Seven academic or general medical hospitals. PARTICIPANTS: Thirty-six symptomatic HIV-infected patients (Centers for Disease Control and Prevention stage IV) with a CD4+ count > or = 150 x 10(6)/l and Karnofsky Performance Status score > or = 60, who had not received ZDV or IFN-alpha before. METHODS: QoL was assessed using two self-report questionnaires (the European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire and an AIDS-specific questionnaire), administered before and every 3 months after the start of the treatment. RESULTS: There were no significant differences in QoL between the two treatment groups over a 1-year period. Emotional, cognitive and social functioning improved in the entire group, and patients reported fewer symptoms (for example, shortness of breath, nausea and vomiting, influenza-like symptoms, diarrhoea, lack of appetite, taste disturbances, dizziness, weight loss, trouble in vision) and a better overall QoL until month 9. Thereafter, emotional, cognitive and social functioning and overall QoL deteriorated and patients reported more symptoms. Major complaints at baseline and follow-up were associated with fatigue and emotional functioning: patients reported a strong need to rest, and felt very tired, worried, tense and irritable. CONCLUSIONS: These results show that both treatments may have a temporary beneficial effect on patient QoL. QoL research may contribute to evaluation of clinical trials and provide patients with information about the effects of treatment on their QoL, thus enabling them to make informed decisions.

The effect of supportive pamidronate treatment on aspects of quality of life of patients with advanced breast cancer.

Selective aspects of quality of life during supportive pamidronate (APD) treatment were assessed in breast cancer patients with osteolytic metastases. 144 patients were randomised to a pamidronate group (n = 76) or a control group (n = 68). A questionnaire measuring mobility impairment, bone pain, fatigue and gastrointestinal toxicity was administered at 3-monthly intervals. The analysis focused on changes in these quality of life domains over time. The median follow-up for both groups was 18 months. Mobility impairment and bone pain were significantly less in the pamidronate group as compared with the control group, due primarily to a rapid improvement shortly after initiation of pamidronate treatment. Thereafter, a gradual increase in these symptoms was noted in both groups. Gastrointestinal complaints and fatigue levels were similar over time in the two groups, suggesting that these symptoms are more dependent on disease-related events and cytotoxic treatment than on pamidronate treatment. The results indicate that reduced skeletal morbidity in breast cancer patients during pamidronate treatments is associated with an improvement in selective aspects of quality of life.

Quality of life: some theoretical issues.

The concept "quality of life" is becoming increasingly popular in both the medical and general press. However, from a literature survey of approximately 100 scientific publications in which this concept was used, it appeared that rarely is a definition of this term given. Therefore, it seems useful to formulate several guiding principles: (1) "Quality of life" apparently is too vague a concept. It seems more sensible to isolate a number of relevant factors and to choose the best operational definition possible. The following factors may be considered: daily activity, pattern of complaints, subjective feeling of well-being, and sexual behavior. Based upon these factors one composite score of psychological and social consequences should be developed, analogous to an IQ test. (2) The patient is the sole authority concerning questions on "quality of life." (3) The concept "quality of life" should indicate more than a person's momentary well being, since this is dependent on mood, physiologic state, accidental events, etc. It is not the situation at one specific point which should be considered but the situation over a certain period. (4) Questions concerning "quality of life" should be put relatively. For example, does a person have more or less complaints during one period as compared to another? A second possibility is to compare a person's answers to those of a carefully chosen control group. It is essential to keep in mind that these psychologic measures are descriptive; they indicate how patients feel during a certain period concerning the above-mentioned areas and are definitely not normative in the sense of stating what is or is not desirable.

A pain monitoring program for nurses: effects on communication, assessment and documentation of patients' pain.

Nurses need to be informed about the patient's pain to be able to take appropriate measures to alleviate pain. However, communication, assessment, and documentation of pain by nurses is often a problemfor hospitalized patients. In this study we aimed to overcome the main barriers by developing, implementing, and evaluating a Pain Monitoring Program (PMP) for nurses. The PMP consists of two components: educating nurses about pain, pain assessment and pain management; and implementing daily pain assessment by means of a numeric rating scale. We describe the effects of the PMP on communication about pain between nurses and patients and between physicians and patients, agreement between patients 'pain intensity and nurses estimations of patients'pain intensity, and documentation about pain in the nursing records. Factors that might influence communication, assessment, and documentation are also discussed. The effects of the PMP were measured in a quasi-experimental design with a nonequivalent control group. In total, 703 patients participated: 358 patients in the control group and 345 in the intervention group. Results of the control group showed that communication about pain between nurses and patients, agreement between patients' and nurses pain ratings, and documentation about pain in nursing records, remain inadequate. Patients'pain intensity and age were related to communication, assessment, and documentation. Communication and documentation is better in patients with moderate to severe pain than in patients with mild pain, and assessment is better in patients with mild pain. Older patients communicate less with nurses and physicians about pain, and nurses document less about pain in nursing recordsfor older patients compared with younger patients. The PMPproved to be effective in improving nurses'assessment of patients 'pain and documentation about pain in nursing records. Patients' pain intensity and care setting were related to the efficacy of the PMP Communication about pain between patients and nurses, and between patients and physicians did not improve as a result of the PAIP Based on this study it can be concluded that in using a simple method such as the numeric rating scale, together with an education program, attention is focused in a systematic way on patients'pain complaints and creates a common language between patients and nurses. Because the PMP proved effective in a heterogenous population in multiple care settings, it is recommended to implement the PMP in nursing practice.

A pain monitoring program for nurses: effects on nurses' pain knowledge and attitude.

One of the reasons for inadequate pain treatment in hospitalized patients is that nurses have insufficient knowledge about pain and pain management. To address this problem, a Pain Monitoring Program (PMP) for nurses was developed, implemented, and evaluated. The PMP consisted of two components: educating nurses about pain, pain assessment, and pain management, and implementing daily pain assessment by means of a numeric rating scale. The effects of the PMP were measured in a one-group pretest-post-test design. The results show that nurses have knowledge deficits and prejudices with regard to pain and pain management. Age and additional pain courses in pain partly predict nurses' pain knowledge. After nurses were educated, the average score on the Pain Knowledge Questionnaire increased from 69.1% (SD = 13.2) at pretest to 75.8% (SD = 11.5) at post-test (P < 0.001). Nurses' attitudes changed with regard to their level of knowledge and skills in relieving pain, willingness to assess pain on a daily basis, and attention to patients' pain complaints. It can be concluded that the PMP is effective in improving nurses' knowledge of pain management and focusing nurses' attention to patients' pain complaints.

Psychosocial and surgical aspects of breast reconstruction.

Why are only less than 1% of the mastectomized women in The Netherlands reconstructed? We report the results of four studies, among reconstructed patients and their partners, among women who had an amputation only and among general and plastic surgeons in The Netherlands. In contrast to what is thought by (plastic) surgeons, women do not opt in the first place for breast reconstruction because of emotional or cosmetic reasons, but to be freed from the prosthesis. Surgeons hardly ever take the initiative to inform patients about breast reconstruction. Knowledge about breast reconstruction is gained mainly from the mass media. Nearly all reconstructed patients are satisfied with the results. This is independent of the objective cosmetic results. In our opinion amputated women should be informed about breast reconstruction in the same way as about the external prostheses. We also reviewed the surgical aspects concerning indications, timing and available techniques of breast reconstruction. We concluded that the improved surgical procedures make breast reconstruction less burdensome for the patients than the older surgical techniques.

Evaluation of breast conserving therapy: clinical, methodological and psychosocial perspectives.

Uncontrolled studies suggest that breast conserving therapy can replace radical mastectomy in stage I and stage II breast cancer. Results derived from randomized trials support this conclusion for stage I patients. Although the data are only preliminary, several recent trials also suggest that equivalent results can be obtained in stage II disease. Despite these positive findings, caution should be applied in interpreting the results of both uncontrolled and controlled studies in breast cancer. Issues of concern include variations in the methods of staging disease, short follow-up, failure to report locoregional recurrence rates, and interinstitutional differences in treatment technique and protocol procedures. The introduction of substudies to evaluate the psychosocial and cosmetic results of breast conserving therapy add an important dimension to the overall interpretation of the results.

Health-related quality-of-life evaluation in HIV-infected patients. A review of the literature.

This article presents a review of the literature on health-related quality-of-life (HRQOL) measurements in HIV-infected patients by means of multidimensional self-report questionnaires. Since 1989, 11 HRQOL instruments have been used, the most frequently employed scales and items being derived from the Medical Outcomes Study. The 9 instruments that were evaluated for their internal consistency reliability and validity generally met the conventional levels of psychometric performance. Descriptive longitudinal and psychometric studies that examined the ability of HRQOL instruments to distinguish between diagnostic groups consistently showed that, over time, patients developed more symptoms and reported poorer physical, role and sexual functioning. Patients' psychological functioning improved or remained at approximately the same level. Despite some methodological limitations, the 4 HRQOL studies performed as part of clinical trials provided valuable information for both patients and doctors about the impact of treatment with zidovudine, interferon-alpha or epoetin (recombinant human erythropoietin) on patients' HRQOL. Future studies are needed that provide more information on the feasibility, stability and responsiveness of existing HRQOL instruments. In addition, future studies should focus on the natural history of HRQOL in HIV-infected patients, and on the impact of commonly prescribed prophylactic and antiretroviral drugs on patients' HRQOL. There is an urgent need for translations and cultural adaptations of HRQOL instruments for use in different HIV-infected populations, including women, children, intravenous drug users and patients from African and other developing countries.

Underreporting by cancer patients: the case of response-shift.

There are a lot of studies in which self-report questionnaires are used, showing that cancer patients do not have a lower quality of life than the normal healthy population. This seems to be in contrast with the results of studies in which more extensive interviews have been used and to the everyday experience of physicians, nurses and other caretakers. This phenomenon of underreporting seems to hold true also for other patient groups. Judgment theories explain how the perception of quality of life arises. These theories indicate how the conceptualization of the dimension to be measured, changes under the influence of a (highly significant) life event, such as getting a life threatening disease. These theories hold that there will be a concurrent change in the internalized standard on which the patients base their perception. Thus a real effect, for example a decrease in quality of life as a result of cancer, can be obscured totally. Until an empirically proven solution to this problem has been found, we recommend that answers in questionnaires concerned with quality of life, psychological distress and the like should be approached with due caution.

Deterioration of olfaction and gustation as a consequence of total laryngectomy.

INTRODUCTION: After total laryngectomy the absence of a nasal airflow results in a decrease in olfaction and perception of flavors. MATERIALS AND METHODS: Odor perception was assessed in 63 laryngectomized patients with two different olfactory tests. The methods used by patients to smell were observed during olfactory testing. Patients' judgment about their olfaction and gustation was assessed by means of a structured questionnaire, semistructured interview, and self-rating. RESULTS: Based on the results of the olfactory tests, patients were categorized as "smellers" and "nonsmellers." Approximately one third of the patients were able to smell the odorous substances used in the olfactory tests. The smellers more often used a variety of methods to smell than the nonsmellers (P < .002); in most patients the method consisted of active use of facial muscles. Patients appeared well able to judge their own odor perception. Compared with the smellers, the nonsmellers judged their odor perception as worse (P < .003) and reported a more severe decrease in gustation after the operation (P < .033). The results of this study in laryngectomized patients confirm the interrelation between olfaction and gustation: the nonsmellers reported a poorer gustation and a more severe decrease in gustation and appetite than both the smellers and a reference group of elderly persons (P < .05). Patients who reported a deterioration of olfaction and gustation tended to experience negative consequences such as the inability to smell smoke, leaking gas, or agreeable odors. CONCLUSION: Olfaction and odor-related flavor sensation are seriously deteriorated after total laryngectomy.

Rehabilitation of olfaction after laryngectomy by means of a nasal airflow-inducing maneuver: the "polite yawning" technique.

OBJECTIVE: To develop a nasal airflow-inducing maneuver and apply it in the olfactory rehabilitation of patients who have undergone laryngectomy. DESIGN: Intervention study; before-and-after trial. SETTING: National cancer center. PATIENTS: Forty-four patients who underwent laryngectomy; 34 men and 10 women; mean age, 64 years (range, 42-80 years); mean time since surgery, 6 years (range, 8 months to 18 years). INTERVENTION: In a prospective clinical intervention study, we assessed the effectiveness of a nasal airflow-inducing maneuver ("polite yawning," ie, yawning with closed lips). Speech therapists trained the patients in the maneuver, and its effectiveness in inducing nasal airflow was checked with digital and water manometers. MAIN OUTCOME MEASURES: Olfactory acuity was assessed before and after the intervention by means of an odor detection test and a structured questionnaire concerning olfaction, taste, and appetite. Patients were categorized as "smellers" and "nonsmellers" on the basis of the results of the odor detection test and the present odor perception scale derived from the questionnaire. RESULTS: The nasal airflow-inducing maneuver could be taught to all patients, mostly in only one 30-minute therapy session. Fifteen of the 33 patients in the pretreatment nonsmeller category converted to smellers, for a success rate of 46% (P<.001). CONCLUSION: The nasal airflow-inducing maneuver (the "polite yawning" technique) allowed almost half of the patients to recover their sense of smell.

A 14-year investigation into the workload of oncology nurses in The Netherlands Cancer Institute.

In the Netherlands Cancer Institute, the daily workload of nurses has been measured since 1976. Each day the head nurse ranks the patients into one of the seven categories of care requirements. It can be inferred from the data that the percentage of patients who need intensive nursing care has doubled from 30% in 1976 to more than 60% in 1989. The increase in the nursing staff has only partially kept abreast of the increase in the workload. In addition to this simple technique, a more refined "factor evaluation system" has been developed. On the basis of this method, a more detailed check can be made as to what connection there is between the characteristics of the patient, the particular disease and treatment on the one hand, and the nursing workload on the other. Because of this it is possible to assess and to predict the consequences for nursing care when a new therapy is introduced. The correlation between both assessment methods is good: 0.72. A plea is made to use both methods of assessment in conjunction: the simple method for assessing the daily workload, and the refined and thus more laborious method to analyze the factors responsible for changes in the workload. In view of the rapid dissemination of new oncological therapies, it is essential that international consensus be reached with regard to a method for measuring the workload of nurses. In this way the consequences of these new therapies for the workload of nurses might be known more rapidly and proper measures could be taken.

Totally implantable venous access ports--the patients' point of view. A quality control study.

After implanting > 150 totally implantable venous catheters, 40 patients were interviewed about their experiences by telephone using a standard questionnaire. There were 25 women and 15 men, all having or having had chemotherapy for nonresectable advanced cancer, 26 of them by means of a portable pump. Almost all patients thought that the advantages of the Port-a-Cath (PAC) outweighed its disadvantages; they were not hindered in their daily activities, and none of the patients experienced problems with sexual intercourse because of the PAC. Drawbacks of the method are that 40% of the patients found the operation for insertion of the PAC to be more painful than they had expected. Although PAC reduced the fear of repeated peripheral vein puncture, puncture of the PAC was viewed as painful by 15 of the 40 patients. We conclude that a PAC seems to be preferable to an external catheter but that pre- and postoperative patient information needs to be improved.

[Complementary therapies in the hospital:'if you can't beat them, join them'?]. / Complementaire geneeswijzen in het ziekenhuis: 'if you can't beat them, join them'?

Some major cancer hospitals in the United States have established a department for complementary medicine as a service to their patients. Surveys in the Netherlands have shown that notably nursing staff and consumers consider the availability of complementary therapy in health care to be very important. Nevertheless, this appears to be an undesirable development as the effectiveness of these therapies has not been demonstrated and the therapists involved might interfere with regular patient therapy.

[The hidden treasure-chests of the regional cancer registries]. / De verborgen schatkamers van de integrale kankercentra.

For physicians and patients, knowledge of the treatment results of individual hospitals is of great importance as it is known that hospitals with more experience perform better. Oncological characteristics of cancer patients in the Netherlands are collected by the nine Comprehensive Cancer Centres. The data are available from each affiliated hospital but remain anonymous. A plea is made for more transparency by requiring that the Comprehensive Cancer Centers place their data in the public domain.