Methode M-366 (German Edition)
When we started to design the present investigation in the results of the Watson et al. The possible link between psychological factors and the survival rate was and still is a subject of intensive controversies [ 22 ], [ 23 ], [ 24 ], [ 25 ], [ 26 ] in general as well as in the field of hemopoietic stem cell transplantation HSCT [ 19 ], [ 27 ]. Beside the studies by Watson and colleagues [ 13 ], [ 14 ] no other prospective study using the MAC scale as measure has shown convincing associations to survival time. Three descriptive studies are relevant for this topic in the field of HSCT [ 28 ], [ 29 ], [ 30 ].
Andrykowski et al. Jenkins et al. In both studies, they could not find an association between MAC scale and the survival rate.
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Methodological shortcomings [ 27 ], the small numbers of participants of these studies, and the heterogeneity of results did not offer an empirical basis for a hypothesis testing approach for our study. Therefore, the aim of our study is to explore whether there exist any links between coping styles as measured by the MAC scale administered before performing allogenic HSCT and survival thereafter. The study was approved by the ethics committee of Ulm University.
Inclusion criteria were being eighteen years of age or older, fluency in German and having been scheduled for the first allogenic peripheral blood stem cell or bone marrow transplantation.
At hospitalization, patients were informed about the study, that participation in the study was voluntary and that nonparticipation would have no impact on their treatment in the unit. Prior to the investigation, written informed consent was obtained from the patients and questionnaires were administered.
They were answered before HSCT.
A follow-up of two years was planned for each patient. Of them, 31 did not fulfill the inclusion criteria, eight were not approached in time, and one patient did not proceed to HSCT.
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Of the remaining patients, Our analysis is restricted to data of patients with a complete data set of target variables eight questionnaires with missing values, five patients without the necessary physicians' assessments. To measure the psychological response we used the Mental Adjustment to Cancer Scale [ 31 ]. This instrument is a item questionnaire addressing reactions of patients on having cancer.
Each item is assigned to exactly one of the five subscales. Scores for the subscales are calculated by adding up the answers of the assigned items. Following are examples for items:.
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There is currently no system available to help characterize the prognosis for haematological diseases in general. For CML, for example, such an index was proposed [ 32 ], but this index is not transferable to acute leukaemia without making some changes to it. Other recently suggested prognostic indices, e.
With respect to the diversity of potential risk factors, we looked for a global indicator for prognosis and decided to use the transplanting physician's expertise. From an earlier study performed in Ulm, we knew that physicians' assessments ascertained before transplantation were highly predictive for long term outcome [ 35 ]. To replicate the earlier findings, we checked the prognostic validity of this assessment by using Cox regression and Kaplan-Meier survival analysis methods. Two strategies to evaluate the MAC scale were suggested by Watson et al. First, we looked for the predominant response from the subscales FS, HH, F, and AP via calculating z-scores for each scale and looked for the subscale with the highest z-score.
This subscale is the patient's predominant response. If all z-scores are negative, the patient is classified as having no predominant response. The second evaluation used the calculation of cut-off scores for all five subscales. The subscales are dichotomized at the mean plus one standard deviation to differentiate cases from non-cases.
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This criterion results in skewed distributions but has to been seen as "the standard" in this context. Usual descriptive statistics were calculated. Following the procedures of Watson et al. However, with respect to the skewed distributions of the dichotomized MAC subscales we will explore the results using the MAC subscale scores as continuous covariates, too.
Two outcomes were examined by Watson et al. Overall survival defines events as cases of death irrespective of the specific cause of the death. Event-free survival means survival without relapse and focuses on the time from the specific starting point to the point when a relapse was diagnosed or, if no relapse occurred, the patient had died. In our study survival time was calculated as time from date of HSCT until date of event.
If no event was registered, the case was considered as censored and survival time was calculated as time from HSCT until censoring. For censored cases, the date of the most recent documented visit in the hospital was used for calculation. We checked the available records in December Sixty-eight patients had died. Overall survival therefore refers to 68 events. Median follow-up time was 2.
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Of the 38 patients with a relapse post HSCT, 31 died. The seven patients who had relapsed and were alive at follow up represent events when looking at relapse-free event-free survival, thus resulting in 75 events. For the outcome event-free survival median follow-up time was 2.
Tables 1 Tab. No significant results are found. There may be a slight trend for the MAC subscale avoidance A showing a decreased risk if the patient fully agrees to the item "I don't really believe I had cancer", a trend that is more pronounced in the case of overall survival. Our explorative analyses with MAC subscale scores as continuous covariates do not result in remarkable differences compared to the results already reported; therefore we abstain from reporting these numbers.
The trends for the MAC scale A that were mentioned above clearly weaken. We assessed the patients' psychological response to their disease and treatment by using the established MAC scale for a sample of patients facing HSCT, and evaluated overall and event-free survival post HSCT as outcomes.
A physician's assessment of the prognosis, which proved to be highly predictive for survival, served as a variable to statistically control somatic risk factors. With respect to frequency distributions and cut-off scores on the MAC subscales, our results are quite similar to those reported by Watson and colleagues [ 13 ], [ 14 ]. We did not find any relationships between predominant psychological response or any single MAC subscale and event-free or overall survival.
With respect to HH we could not confirm the findings of Watson et al. The range of the confidence intervals HR for HH is nearby between halving and doubling the risk. There is no obvious trend towards a better survival by less HH in our sample. It seems that the findings of Watson et al. This result may have been caused by the different interview settings. Women with early-stage breast cancer who were diagnosed one to three months before inclusion into the study had quite a good prognosis compared to patients facing allogenic HSCT.
This fact is clearly reflected by the survival rates in both studies. In the Watson et al. When facing HSCT, the patients already had passed a significant period of challenges to cope with. Most of them had suffered from other stressful therapies in most cases chemotherapy , and now they had given informed consent to a life-threatening treatment.
Unfortunately we don't have such a baseline measure.
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