I. Frauenklinik, Klinikum der Ludwig-Maximilians-Universität München, Munich, Germany
Received 30 August 2002; revised 3 March 2003; accepted 17 March 2003
![]() |
Abstract |
---|
![]() ![]() ![]() ![]() ![]() ![]() ![]() |
---|
The impact of various medical and demographic factors on the quality of life (QoL) of breast cancer patients has been discussed controversially. We investigated the influence of six different factors on long-term QoL and body image of women with primary breast cancer.
Patients and methods:
Two-hundred and seventy-four breast cancer patients were administered the QoL questionnaire following a mean interval of 4.2 years after primary diagnosis. All women had been primarily treated for stage I to III breast cancer without evidence of distant metastases. QoL was evaluated by using the QLQ-C30 questionnaire Version 2.0. Supplementary scales included body image, satisfaction with surgical treatment, cosmetic result and fear of recurrence. We analyzed the impact of tumor stage, surgical treatment, adjuvant radiotherapy, adjuvant cytotoxic therapy, age and length of follow-up period on the examined outcome parameters.
Results:
At the time of the follow-up examination, patients showed minor impairment of QoL (mean 67.8) and body image (mean 24.8), but more fear of recurrence (mean 60.7). None of the studied factors had a significant impact on overall QoL (P >0.05) according to the QLQ-C30 questionnaire. In contrast, with the exception of the factors cytotoxic therapy and radiotherapy all investigated variables influenced at least one of the additional psychological scales (P <0.05). The primary surgical treatment modality had the strongest impact and affected all four scales. Patients treated with breast conservation reported a more favorable body image, compared to those treated with mastectomy (17.2 versus 37.5, P <0.01), more satisfaction with surgical treatment (4.0 versus 10.7, P = 0.01), rated a better cosmetic result (75.5 versus 57.1, P <0.01), but presented more fear of recurrence (63.9 versus 55.3, P = 0.04).
Conclusion:
Current QoL questionnaires do not sufficiently cover all relevant aspects of QoL, but might be complemented by breast cancer specific aspects such as body image and fear.
Key words: body image, breast cancer, fear of recurrence, follow-up study, quality of life
![]() |
Introduction |
---|
![]() ![]() ![]() ![]() ![]() ![]() ![]() |
---|
There is a lack of data on possible interactions between psychological, medical and sociodemographic factors and QoL [1, 7]. The findings on QoL among long-term survivors of breast cancer are heterogeneous, often contradictory [5, 7, 8, 10]. Several studies investigated the impact of a single parameter, mainly compounds of primary treatment, on QoL of breast cancer patients. Most major studies focused on the impact of primary surgical treatment modality [3, 6, 11, 12], age [1315] and adjuvant chemotherapy [7, 16] on QoL, while other factors, such as tumor stage, adjuvant radiotherapy or follow-up period were often neglected. However, the impact of these factors on the QoL has been discussed controversially. In addition, there is a lack of studies which investigate the differential impact of several oncological and demographic factors on long-term QoL within one clinical trial.
The purpose of the present study was to evaluate the impact of various tumor and treatment associated variables, as well as demographic factors on long-term QoL, fear of recurrence, body image, satisfaction with surgical treatment and cosmetic result.
![]() |
Patients and methods |
---|
![]() ![]() ![]() ![]() ![]() ![]() ![]() |
---|
Primary treatment
The primary surgical treatment consisted of either breast conserving therapy (BCT; 171 patients) or modified radical mastectomy (103 patients) leading to R0 resection in all reported cases. Routine axillary dissection included lymph nodes of levels I and II, while those of level III were excised only in cases with macroscopic metastatic involvement of the lower levels. For the diagnosis of lymph node metastasis, single embedded lymph nodes were screened at up to three levels. Breast reconstruction was not available at the study site and was not offered to the patients. Telecobalt radiotherapy was administered to 164 of 171 patients (95.9%) treated with breast conservation. Chest wall irradiation following mastectomy was performed in 35 patients (34.0%) with large tumors of extensive lymphangiosis carcinomatosa. Postmenopausal patients with positive hormone receptor status (29 patients) received adjuvant endocrine therapy with tamoxifen (20 mg/day). The duration of tamoxifen was 5 years; 21 of the patients were still receiving tamoxifen at the time of assessment. According to local policies, all premenopausal patients with axillary lymph node metastases received adjuvant chemotherapy (69 patients). Patients with one to three involved axillary lymph nodes received cytotoxic therapy that consisted of six cycles of CMF [cyclophosphamide (600 mg/m2 body surface area), methotrexate (40 mg/m2), 5-fluoruoracil (600 mg/m2)] every 21 days. In patients with four or more regional lymph nodes four sequential courses of EC [epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2)] followed by three courses of CMF were given in some cases, while other patients received six courses of DE [epirubicin (90 mg/m2) and docetaxel (75 mg/m2)]. No systemic adjuvant therapy was given to 109 node-negative patients.
Assessment of quality of life, body image, satisfaction with surgical treatment, cosmetic result and fear of recurrence
Quality of life was evaluated by using the QLQ-C30 questionnaire, Version 2.0 of the European Organisation for Research and Treatment of Cancer (EORTC) Study Group on Quality of Life [17, 18]. The questionnaire is composed of the Global Health Status/QoL scale and five functional scales that evaluate physical functioning, role functioning, emotional functioning, cognitive functioning and social functioning. Higher mean scores on these scales represent better functioning and QoL. Three symptom scales measure nausea and vomiting, pain and fatigue. Six single items assess financial impact and physical symptoms of dyspnea, insomnia, appetite loss, constipation and diarrhea. Higher mean values on the symptom scales and single items translate into an increased extent of symptoms.
In addition to the EORTC QLQ-C30 questionnaire, six supplementary items were appended. The hypothesized scale structure of the added items included a body image scale consisting of two questions, a scale that evaluates satisfaction with the primary surgical treatment consisting of two questions, a single item concerning fear of recurrence and a single item on cosmetic result. Higher mean scores on the additional scales represent a more negative body image, less satisfaction with surgical treatment, higher fear of recurrence and a greater satisfaction with the cosmetic result. Variations of these questions have also been used in other studies [6].
Medical and demographic factors
We investigated the following tumor and treatment associated factors: tumor stage at the time of primary diagnosis, primary surgical treatment modality (BCT versus mastectomy), adjuvant radiotherapy (no radiotherapy versus radiotherapy) and adjuvant cytotoxic therapy (no cytotoxic therapy versus cytotoxic therapy). The tumor stage at the time of primary diagnosis was classified according to the International Union Against Cancer (UICC) tumor node metastasis (TNM) classification [19, 20]. The investigated demographic factors comprised the patients age at time of follow-up examination and length of follow-up period, i.e. the interval between primary diagnosis of breast cancer and study visit. Patients age was dichotomized in the two categories 59 years and >59 years. The follow-up period was categorized as <1, 12, 36 and >6 years.
Statistical analysis
Linear transformation was used to standardize the raw scores of the psychological variables so that all scores ranged from 0 to 100. In accordance with The EORTC QLQ-C30 Scoring Manual [21], the questionnaire items were encapsulated in scales of the categories Global Health Status QoL, Functional Scales and Symptom Scales. The additional scales were evaluated statistically in analogy to the symptom scales [21]. Multitrait scaling analysis was employed to verify the hypothesized scale structure of the body image scale and the satisfaction with the primary surgical treatment scale. Evidence of item convergent validity was defined as a correlation of 0.40 between an item and its own scale, corrected for overlap [6]. In addition, the reliability of the two scales was assessed using Cronbachs
-coefficient. To confirm the discriminative validity of the additional variables we examined correlations among the four scales. Substantial correlation between the scales was ruled out if Pearsons correlation coefficient was r <0.40.
We performed analyses of variance (ANOVA) to test for associations between the tumor and treatment associated variables as well as demographic factors and various psychological parameters at the time of the follow-up examination. For this analysis we assessed each of the tumor and treatment associated variables (tumor stage, primary surgical treatment, radiotherapy, cytotoxic therapy) and demographic factors (age, follow-up period), creating a separate ANOVA model for each of the QoL measures (QoL and four functional scales) and for each of the additional scales (body image, satisfaction with surgical treatment, cosmetic result, fear of recurrence). No adjustment was made for multiple comparisons. We used two-sided P-values as descriptive statistics to identify associations between the dependent variables and the independent factors. If the ANOVA indicated significant impact of the observed factor on the QoL and additional scales (P <0.05), we reported means and standard deviations (SDs) within each comparison. In addition, correlation analyses (Spearman-Rho-coefficients and Phi-coefficients) of the six independent variables were calculated and if two independent variables were interrelated (r >0.4), an analysis of covariance (ANCOVA) was conducted. The computer software Statistical Package for the Social Sciences 10.0 (SPSS Inc., Chicago, USA) was used for all calculations.
![]() |
Results |
---|
![]() ![]() ![]() ![]() ![]() ![]() ![]() |
---|
|
Quality of life, body image, satisfaction with surgical treatment, cosmetic result and fear of recurrence at the time of follow-up examination
The questionnaires were answered after a mean interval of 4.2 years (SD 4.5) following primary treatment. The average age of the patients at the time of the follow-up examination was 60.0 years (SD 11.6). Table 2 shows the mean values and SDs of the QoL scale, functional scales and symptom scales according to the QLQ-C30 questionnaire and of the additional scales.
|
Correlation analyses of the independent variables
With two exceptions, all correlations of the six independent variables were low: the Spearman-Rho-coefficients and Phi-coefficients were <0.3. The Spearman-Rho correlation between tumor stage and cytotoxic therapy was moderate (0.40, P <0.01). Patients with better tumor stage classification had less treatment with cytotoxic therapy than patients with worse tumor stage. The variables primary surgical treatment and radiotherapy were highly interrelated (Spearman-Rho 0.67, P <0.01). Women having BCT were more often treated with radiotherapy than women with mastectomy. Because of the interaction of primary surgical treatment and radiotherapy analyses of covariance were conducted.
Impact of medical and demographic factors on quality of life
Tables 3 and 4 illustrate the impact of tumor and treatment associated variables and demographic factors on QoL and the functional scales of the QLQ-C30 questionnaire. Table 3 shows the two-sided P-values of the ANOVA, while Table 4 shows the mean values and SDs of the functional scales according to the various subgroups.
|
|
Impact of medical and demographic factors on additional psychological aspects of quality of life
Tables 5 and 6 summarize the impact of tumor and treatment associated variables and demographic factors on body image, satisfaction with surgical treatment, cosmetic result and fear of recurrence in the follow-up examination. Table 5 shows the two-sided P-values of the ANOVA, Table 6 the mean values and SDs of the additional scales according to the observed independent factors.
|
|
![]() |
Discussion |
---|
![]() ![]() ![]() ![]() ![]() ![]() ![]() |
---|
The QLQ-C30 questionnaire used in our study has been developed as a quantitative measure of health-related QoL for cancer patients [17]. Its validity has previously been well established [18]. We added scales to investigate important psychological aspects of QoL in breast cancer patients, neglected in the standardized questionnaire: body image, satisfaction with surgical treatment, cosmetic result and fear of recurrence. Cronbachs -reliability, convergent and discriminative validity of our subscales were acceptable. The psychometric properties of the additional scales were established so far only within our sample. However, our study group aims at a broad validation of these scales in other clinical samples. In this retrospective, cross-sectional study the follow-up examination was assessed contemporaneously. Because of the retrospective study design and the fact that the surgery was not randomly assigned, our results should be interpreted with caution. The studys use of (univariate) analysis of variance to test for associations between various oncological and psychological factors is in line with the methodology of international cancer clinical trials [1].
Results concerning long-term QoL in breast cancer patients are heterogeneous. Some studies find long-term negative changes of overall QoL and its dimensions [5, 8], others do not demonstrate a permanently and globally impaired QoL of breast cancer patients [7, 10]. In comparison to a sample of the general population without cancer disease [22], patients in our study showed similar overall QoL values. One reason for this observation might be that patients with stage IV tumors at time of primary diagnosis and recurrent breast cancer at time of follow-up examination were excluded. Rather, the vast majority of patients (74.4%) were diagnosed with stage I or IIA tumors. Yet, our sample presents impairments of QoL in comparison to the general population [22] concerning emotional functioning, fatigue and insomnia. One aim of our study was to analyze the psychological long-term impact of the primary surgical treatment. At the time of follow-up examination, body image was moderately impaired, satisfaction with surgical treatment was high and cosmetic results were rated favorably. Remarkably, the patients described a considerable amount of fear of recurrence despite their disease-free interval. In summary, our data suggest that 4 years after diagnosis tumor and primary treatment still influence patients life concerning fear and emotional coping.
Comparing the QLQ-C30 questionnaire and our self-implemented scales, we found a remarkable discrepancy between the two instruments. The studied tumor and treatment associated variables and demographic factors had no significant impact on overall QoL of the standardized questionnaire, but did have an impact on our additional scales. This leads us to two conclusions. First, our scales assess distinct constructs of QoL, not covered by the QLQ-C30 questionnaire. Secondly, our QoL factors might present a more breast cancer specific QoL concept in comparison to the QLQ-C30 questionnaire, including a more general health-related QoL concept. However, one has to keep in mind that other workers, including the EORTC study group, have developed scales specific to breast cancer, for example a breast cancer version of the Rotterdam Symptom Checklist [23], the Functional Assessment of Cancer TherapyBreast [24] and the breast cancer module of the EORTC to be used in addition to the core questionnaire QLQ-C30 [25]. We did not use one of these standardized breast cancer modules because none of them covered the psychological variables we were interested in, in a sufficient and brief module.
The impact of two of the six studied factors on long-term QoL should be discussed in more detail: the time interval between primary diagnosis and follow-up examination, and the primary surgical treatment modality. Patients with a longer follow-up interval reported better physical functioning, whereas patients with a short interval described less body image problems, which is in line with other studies [8]. This observation might be explained by the nature of disease coping at the time of primary diagnosis, which predominantly addresses stress caused by life-threatening and adverse effects of primary therapy. Later on, psychological strains might increase, and thus the patients focus might shift increasingly towards body image problems.
Fallowfield and colleagues found comparable incidence of anxiety states or depressive illness in breast cancer patients irrespective of surgical treatment offered [26, 27]. In our study, in line with previous publications [3, 28, 29], the standardized QoL questionnaire failed to demonstrate a difference in long-term QoL between patients receiving BCT or mastectomy. However, primary surgical treatment modality still strongly influences a patients life. Patients with BCT reported better physical and social functioning, better body image, more satisfaction with surgical treatment and perceived the cosmetic result more positively. Yet, these patients significantly reported more fear of recurrence. The superiority of BCT in terms of body image and satisfaction with treatment is in line with the majority of publications [3, 6, 27, 29], while the question of differences in fear of recurrence between the two subgroups is discussed controversially [11, 30, 31]. In summary, the results of our study confirm that the advantages of BCT prevail even several years after primary diagnosis.
Overall, the impact of oncological and demographic factors on QoL in breast cancer patients is discussed heterogeneously with partly contradicting conclusions. This may be explained by methodological differences between the studies. The variety of measuring instruments and the array of different components of the QoL construct result in difficulties in comparing different studies [1, 29]. Current measurement tools should be required to give physicians and cancer patients clinically relevant information about daily care, assist them in therapeutic decision-making and in identifying the needs concerning psychosocial interventions [2, 9]. Combining the standardized QoL concepts with breast cancer specific psychological variables, namely body image, fear, satisfaction with treatment and cosmetic evaluation, may improve the ability to meet these requirements.
This is the first study to have used the QLQ-C30 questionnaire in conjunction with supplementary psychological scales to analyze the impact of various tumor and treatment associated variables and demographic factors on long-term QoL within one trial. In summary, our results support the hypothesis that current QoL questionnaires do not sufficiently cover breast cancer specific aspects of QoL.
![]() |
Footnotes |
---|
![]() |
References |
---|
![]() ![]() ![]() ![]() ![]() ![]() ![]() |
---|
2. Fallowfield LJ. Assessment of quality of life in breast cancer. Acta Oncol 1995; 34: 689694.[ISI][Medline]
3. Ganz PA, Schag CAC, Lee JJ et al. Breast conservation versus mastectomy. Is there a difference in psychological adjustment or quality of life in the year after surgery? Cancer 1992; 69: 17291738.[ISI][Medline]
4. Grumann M, Schlag PM. Assessment of quality of life in cancer patients: complexity, criticism, challenges. Onkologie 2001; 24: 1015.
5. Hassey Dow K, Ferrell BR, Leigh S et al. An evaluation of the quality of life among long-term survivors of breast cancer. Breast Cancer Res Treat 1996; 39: 261273.[ISI][Medline]
6. Curran D, van-Dongen JP, Aaronson NK et al. Quality of life of early-stage breast cancer patients treated with radical mastectomy or breast-conserving procedures: results of EORTC Trial 10801. Eur J Cancer 1998; 34: 307314.[CrossRef][ISI][Medline]
7. Ganz PA, Rowland JH, Desmond K et al. Life after breast cancer: understanding womens health-related quality of life and sexual functioning. J Clin Oncol 1998; 16: 501514.[Abstract]
8. Muthny FA, Koch U, Spaete M. Psychosoziale Auswirkungen der mastektomie und bedarf an psychosozialer versorgungeine empirisiche untersuchung mit mammakarzinompatientinnen. Psychother Med Psychol 1986; 36: 240249.[ISI]
9. Shimozuma K, Sonoo H, Ichihara K. Analysis of the factors influencing the quality of life of patients with advanced or recurrent breast cancer. Surg Today 1995; 25: 874882.[CrossRef][Medline]
10. Dorval M, Maunsell E, Deschenes L et al. Long-term quality of life after breast cancer: comparison of 8-year survivors with population controls. J Clin Oncol 1998; 16: 486494.
11. de Haes JC, van Oostrom MA, Welvaart K. The effect of radical and conserving surgery on the quality of life of early breast cancer patients. Eur J Surg Oncol 1986; 12: 337342.[ISI][Medline]
12. Lasry J-CM, Margolese RG, Poisson R et al. Depression and body image following mastectomy and lumpectomy. J Chron Dis 1987; 40: 529534.[ISI][Medline]
13. Wenzel LB, Fairclough DL, Brady MJ et al. Age-related differences in the quality of life of breast carcinoma patients after treatment. Cancer 1999; 86: 17681774.[CrossRef][ISI][Medline]
14. Ganz PA, Schag CC, Heinrich RL. The psychosocial impact of cancer on the elderly: a comparison with younger patients. J Am Geriatr Soc 1985; 33: 429435.[ISI][Medline]
15. Nerenz DR, Love RR, Leventhal H, Easterling DV. Psychosocial consequences of cancer chemotherapy for elderly patients. Health Serv Res 1986; 20: 961976.[ISI][Medline]
16. Hürny C, Bernhard J, Coates AS et al. Impact of adjuvant therapy on quality of life in women with node-positive operable breast cancer. Lancet 1996; 347: 12791284.[CrossRef][ISI][Medline]
17. Aaronson NK, Ahmedzai S, Bergman B et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993; 85: 365376.[Abstract]
18. McLachlan S-A, Devins GM, Goodwin PJ. Validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) as a measure of psychosocial function in breast cancer patients. Eur J Cancer 1998; 34: 510517.[CrossRef][ISI][Medline]
19. Sobin LH, Fleming ID. TNM classification of malignant tumors. Cancer 1997; 80: 18031804.[CrossRef][ISI][Medline]
20. Sobin LH. Frequently asked questions regarding the application of the TNM classification. Cancer 1999; 85: 14051406.[CrossRef][ISI][Medline]
21. Fayers PM, Aaronson NK, Bjordal K et al. The EORTC QLQ-C30 Scoring Manual, 2nd edition. Brussels, Belgium: European Organization for Research and Treatment of Cancer 1999.
22. Hjermstad MJ, Evensen SA, Kvaloy SO et al. Health-related quality of life 1 year after allogeneic or autologous stem-cell transplantation: a prospective study. J Clin Oncol 1999; 17: 706718.
23. Hopwood P, Howell A, Maguire P. Screening for psychiatric morbidity in patients with advanced breast cancer: validation of two self-report questionnaires. Br J Cancer 1991; 64: 353356.[ISI][Medline]
24. Brady MJ, Cella DF, Mo F et al. Reliability and validity of the functional assessment of cancer therapy breast quality-of-life instrument. J Clin Oncol 1997; 15: 974986.[Abstract]
25. Sprangers MAG, Groenvold M, Arraras JI et al. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol 1996; 14: 27562768.[Abstract]
26. Fallowfield LJ, Baum M, Maguire GP. Effects of breast conservation on psychological morbidity associated with diagnosis and treatment of early breast cancer. Br Med J 1986; 293: 13311334.[ISI][Medline]
27. Fallowfield LJ. Psychosocial adjustment after treatment for early breast cancer. Oncology 1990; 4: 8997.[CrossRef][Medline]
28. Pozo C, Carver CS, Noriega V et al. Effects of mastectomy versus lumpectomy on emotional adjustment to breast cancer: a prospective study of the first year postsurgery. J Clin Oncol 1992; 10: 12921298.[Abstract]
29. Janni W, Rjosk D, Dimpfl T et al. Quality of life influenced by primary surgical treatment for stage IIII breast cancerlong-term follow-up of a matched-pair analysis. Ann Surg Oncol 2001; 8: 542548.
30. Kiebert GM, de Haes JC, van de Velde CJ. The impact of breast-conserving treatment and mastectomy on the quality of life of early-stage breast cancer patients: a review. J Clin Oncol 1991; 9: 10591070.[Abstract]
31. Schover LR. The impact of breast cancer on sexuality, body image, and intimate relationships. CA Cancer J Clin 1991; 41: 112120.