Socio-demographic and medical characteristics of advanced cancer patients using conventional or complementary medicine.

BACKGROUND: To provide prospective comparative data describing the profiles of two patient populations attending conventional or complementary medicine institutions. PATIENTS AND METHODS: A registration study was set up in an oncology ward at the Institute for Medical Oncology (IMO) of the University Hospital in Bern, and at the Lukas Clinic (LC) for Anthroposophical Cancer Treatment in Arlesheim, Switzerland. The same eligibility criteria were applied to enrol into the study all newly referred or newly diagnosed patients with advanced cancer over a 2-year period. Their socio- demographic and clinical characteristics at presentation have been compared between the two institutions. RESULTS: Patients at LC are primarily females, of higher educational level, and living in an urban environment. Patients at LC are also more frequently of poorer performance status but present with less comorbidity and a longer interval between diagnosis of metastatic disease and accrual into the study. CONCLUSION: This study suggests that the respective merits of these two schools of medicine can be assessed successfully only through a concrete research partnership based on rigorously controlled clinical trials.

Experiences in the realisation of a research project on anthroposophical medicine in patients with advanced cancer.

QUESTIONS UNDER STUDY: To date most of the published studies on the effectiveness of complementary therapies in cancer patients have yielded controversial results because of questionable methodology. Research strategies and methodologies acceptable to both conventional and unconventional medicine are difficult to find due to different belief systems. In this publication we describe the development and implementation of a project conducted as part of National Research Programme 34 (NFP 34). Detailed analysis of our experiences might provide some information on how to deal with practical difficulties in the planning and conduct of further research projects in this field. The project involved the anthroposophical Lukas Clinic in Arlesheim and the Institute of Medical Oncology of the University Hospital, Berne. This interdisciplinary research project was devised to study the relative merits of these two schools of medicine in the care of advanced cancer patients. The project was made up of three components: (1) a registration study aimed at comparing the case mix at the two institutions; (2) a three armed randomised study on the effectiveness of supportive therapy, comparing anthroposophy to psychosocial group therapy, and (3) a longitudinal study to monitor the evaluation of quality of life of patients at the anthroposophical clinic. METHODS: After a brief review of the study protocol, which presents the theoretical framework of the project, problems of its implementation are described. Aspects of accrual, acceptance of randomisation and data availability are presented using simple descriptive statistics and logistic regression. RESULTS: The registration study was duly completed with a total of 567 patients. For several reasons (not meeting inclusion requirements, high refusal rate) the accrual into the randomised study was slower than expected and required modification of the original design specifications with regard to inclusion criteria and data collection schedule. Additionally, a high dropout rate contributed to premature closure of this part of the project. The longitudinal study also suffered from low data availability at follow up. CONCLUSIONS: The study protocol constituted a major effort at compromise without loss of scientific rigour, and this effort demonstrates that it is possible to allow for different views on patients, on clinical interventions and on research strategies when establishing collaboration between different schools of medicine. Despite a theoretically sound framework, the randomised part of the project proved difficult in its practical execution. Some unexpected logistical constraints and some unmet expectations influenced the feasibility of this part of the project. Therefore, careful planning of research projects in this field of medicine should always include an extended analysis of various practical aspects of study implementation.

[Does a psychosocial group intervention program alter the quality of life of cancer patients?]. / Verändert ein psychosoziales Gruppeninterventionsprogramm die Lebensqualität von Krebspatienten?

BACKGROUND: Structured, multicentre psychosocial support programmes are rare in Switzerland. The Swiss Cancer League has therefore designed a programme of this kind for cancer patients, and the effect on quality of life (QL) is investigated in the present study. METHODS: The programme consisted of 10 weekly 2-hour sessions and was carried out, on the basis of a manual, in 10 cities of German-speaking Switzerland. QL was assessed by standardised tools (HAD, EORTC, QLQ-C30, SELT-M, LASA) before, immediately after, and 9 months post baseline. Patients' personal impressions of the programme were gathered by telephone. RESULTS: 134 patients (25 males, 109 females), mean age 51.9 years, took part in the programme. 50% had breast cancer and the other half a variety of tumours. 25 patients attended only the educative part of the programme, while of the remaining 109, 41% attended all 10 sessions, 50% 7-9 and 9% 4-6. 80-90% had a favourable impression of the individual sessions and their content. Significant QL changes in the desired direction were observed in regard to emotional functioning (Wilcoxon p = 0.011), anxiety (p = 0.0005), depression (p < 0.0001), general life orientation (p = 0.006) and spiritual QL (p = 0.012). More optimistic patients showed a more positive change in physical well-being (Kurskall-Wallis p = 0.0005) and QL in general (p = 0.0006). CONCLUSION: A psychosocial support programme is well received by cancer patients after adjuvant treatment and leads to favourable QL changes, although independent time effects cannot be ruled out. Similar programme should be considered more often in standard oncological treatment regimens.

Attitudes and Beliefs towards Disease and Treatment in Patients with Advanced Cancer Using Anthroposophical Medicine.

BACKGROUND: In Switzerland, anthroposophical medicine has a long tradition, offers a special tumor treatment, is frequently used by cancer patients, and has been approved in 1998 by the Swiss government to be reimbursed by health insurances. This popularity contrasts with the fact that to date no sound evidence of the effectiveness of anthroposophical cancer treatments exists. In this study we draw a profile on a population of patients with advanced disease attending treatment at the anthroposophical Lukas Clinic (LC) regarding patients' attitudes, experiences and expectations. PATIENTS AND METHODS: All newly admitted patients with a diagnosis of locally advanced or metastasized breast, gastrointestinal, lung or gynecological cancer were recruited into a registration study. In parallel, a population of patients with the same inclusion criteria attending a conventional institution (Institute of Medical Oncology, University of Bern, IMO) was taken as a reference sample. Data were collected by means of a fully structured interview, and simple descriptive statistics was used for evaluation. RESULTS: 221 and 280 patients accrued at LC and at IMO, respectively. LC patients were mainly women (87%), had a good education (36% with completed college or university education), and were admitted on average 3.5 months after the diagnosis of advanced disease. With respect to their advanced cancer, they put very little hope in the effectiveness of conventional medicine, but expected great help from anthroposophical treatment. Compared with the reference population they cared more for psychological well-being and quality of life, but an important factor for choosing treatment at the LC was clearly the patients' strong belief in the effectiveness of anthroposophical treatment. CONCLUSIONS: With its holistic approach, anthroposophical medicine intends to provide tumor treatment together with supportive care throughout the course of the illness. To some patients this is an attractive alternative to conventional medicine, which too often focuses on tumor treatment only. Conventional medicine should clearly be advised to give higher priority to supportive care already early in the course of the disease. We acknowledge some patients' need for a more holistic approach, but anthroposophical medicine or any other providers of alternative or complementary cancer therapies should evaluate treatment effectiveness more thoroughly according to the principles of evidence-based medicine. Copyright 2000 S. Karger GmbH, Freiburg

The cognitive-spiritual dimension--an important addition to the assessment of quality of life: validation of a questionnaire (SELT-M) in patients with advanced cancer.

UNLABELLED: Questions of meaning and challenge by illness, i.e., the spiritual dimension of quality of life (QL) traditionally played an important role in anthroposophically oriented medicine and have gained importance in palliative medicine and supportive care. In the context of a research project on QL in patients with advanced cancer, we therefore investigated the psychometric properties of a questionnaire covering spiritual QL issues, with the aim of providing a module for the assessment of cognitive-spiritual QL. PATIENTS AND METHODS: We investigated 89 patients with advanced breast and gastro-intestinal cancer. Construct validity of a modified version of the SELT (Skalen zur Erfassung von Lebensqualität bei Tumorkranken), the SELT-M was tested by multitrait scaling analysis. Discriminant and convergent validity were also tested. The EORTC QLQ-C30 was used as a standard for validation. Results showed the SELT-M as feasible in administration. Four of the five SELT-M subscales were internally consistent (Cronbach's Alpha = > 0.7). The subscale on spiritual QL showed higher within than outside subscale correlations for six of its eight items. Association of the SELT-M with the EORTC QLQ-C30 was good for the items and subscales covering the same aspects of QL in both questionnaires: emotional (Spearman r = 0.61), physical functioning (r = -0.54) and fatigue (r = -0.75). In accordance with expectations, there was no association between spiritual QL with any EORTC QLQ-C30 subscales. Self-assessed spiritual QL in the SELT-M corresponded well with interviewer assessments (test for trend accross ordered groups, P = 0.0023). CONCLUSIONS: Overall there is confirming evidence for the hypothesised structure of the SELT-M, especially for the newly developed module on spiritual QL. This module may be used as a module together with other cancer specific QL questionnaires.

Subjective health estimations (SHE) in patients with advanced breast cancer: an adapted utility concept for clinical trials.

We wished to develop and validate a simple linear analogue self-assessment (LASA) scale to assess utility values in multicentre, multicultural breast cancer trials. We compared two variants of a LASA scale (score range 0-100) with different anchoring points [perfect health to worst possible health (subjective health estimation, SHE) and perfect health to death (SHED)] in 84 patients with advanced breast cancer. Feasibility was explored in the first 48 patients interviewed. Values from the LASA scales were compared with each other and with a time trade off (TTO) interview. Scores from the two LASA scales were highly correlated (r=0.8, P < 0.0001, Spearman). The relationship between TTO interview and SHE was confirmed with tests for trend across ordered groups (linear-trend test P < 0.001). Most patients preferred SHE to SHED. SHE scores (in which high scores indicate high-health-state values) were significantly different by type of treatment, time from diagnosis and age. Thus, significantly different mean SHE scores were obtained from patients receiving no treatment or hormone therapy, mild and intensive chemotherapy (ANOVA P=0.03) and from patients with diagnosis 2 years, 2-5 years, 5-10 years and more than 10 years before interview (ANOVA P=0.02). Older patients (> 56 years) had a lower mean on the SHE scale (53 vs 61; ANOVA P=0.04). We found that the two versions of the LASA scale were equivalent for clinical purposes. SHE appeared to provide a feasible, patient-preferred and valid alternative to lengthy TTO interviews in assessing the value patients attach to their present state of health in large-scale cancer clinical trials.

The Perceived Adjustment to Chronic Illness Scale (PACIS): a global indicator of coping for operable breast cancer patients in clinical trials. Swiss Group for Clinical Cancer Research (SAKK) and the International Breast Cancer Study Group (IBCSG).

Subjective well-being is a major aspect of quality of life and is therefore increasingly used as an endpoint in clinical trials. It is influenced to a great extent by the complex process of coping with the disease and its treatment. Assessment of coping is methodologically demanding, especially in large clinical trials. We therefore developed a single-item measure, the Perceived Adjustment to Chronic Illness Scale (PACIS), as an indicator of coping, complementary to other scales related to quality of life. We sought to validate this instrument in a subgroup of 121 Swiss patients participating in the International Breast Cancer Study Group (IBCSG) adjuvant trials. At months 3 and 6 of adjuvant treatment PACIS showed a distinct pattern of highly significant rank correlations with several disease- and treatment-related problem areas from the Herschbach coping inventory (FBBK); 42% of the variance of PACIS at month 3 was explained by the FBBK (P = .0001). The portion of explained variance was considerably higher for the Italian- (70%) than for the German-speaking (30%) subgroups. Patients who rated more effort to cope with their disease on PACIS indicated more frequent use of 3 of 15 coping strategies in relation to psychological distress. These were "crying and becoming desperate", "taking tranquillizers and alcohol" and "other people are far worse off". These three coping strategies may define a high-risk group for poor psychosocial outcome. Patients whose PACIS scores showed that it required less effort to cope tended to use the strategy "seeing a positive side of the problem". We conclude that PACIS can be used as a global indicator of the coping process in large multicultural clinical trials of adjuvant therapy for breast cancer.