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Efficacy and costs of two forms of stress management training for cancer patients undergoing chemotherapy |
Jacobsen P B, Meade C D, Stein K D, Chirikos T N, Small B J, Ruckdeschel J C |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology The study examined a self-administered form of stress management training (SSMT) for patients about to undergo chemotherapy. The self-administered method was compared with professionally administered stress management training (PSMT) and "usual psychosocial care".
Economic study type Cost-effectiveness analysis
Study population The study population comprised cancer patients who had not received prior intravenous chemotherapy, and who were scheduled to receive a minimum of four cycles of intravenous chemotherapy with a minimum of 7 days between cycles. They also had to not be scheduled to receive radiation therapy before the start of the fourth chemotherapy cycle, be English speaking, and able to give written, informed consent.
The age of the participants ranged from 26 to 88 years (mean 56, standard deviation 12). The participants were mainly female, white, married and had attended college.
Setting The setting was tertiary care. The economic study was carried out in Florida, USA.
Dates to which data relate The dates for the effectiveness data were not stated. The resource use data were imputed retrospectively. The prices were taken from published sources for the year 1999 to 2000.
Source of effectiveness data The effectiveness data were derived from a single study.
Link between effectiveness and cost data The costing was based on the description of PSMT and SSMT interventions used by the patient sample in the effectiveness analysis.
Study sample No power calculations were carried out prior to the study. The authors did not describe in detail how the sample was selected from the eligible population. However, the sample appears to have been appropriate for the study question. Of the 507 patients invited to take part in the trial, 96 (19%) declined the invitation. The remaining 411 patients were randomised to UCO (137), PSMT (134) or SSMT (140).
Study design This was a single-centre, randomised controlled trial. The patients were randomised by means of an automated telephone response system. Blinding was not possible due to the nature of the interventions. The patients were followed for up to 4 cycles of chemotherapy. Twenty-nine patients (5 in UCO, 9 in PSMT and 15 in SSMT) withdrew or became ineligible to enter the study after randomisation. The reasons included mortality and changes in treatment plans. A total of 291 patients completed at least one follow-up questionnaire, while 91 patients did not complete any follow-up questionnaire.
Analysis of effectiveness The authors checked the 291 complete datasets with the 91 incomplete sets for any systematic differences, but they did not state whether the final analysis was performed on all 382 ("intention to treat" analysis) or on only the 291 complete sets ("treatment completers").
Quality of life was measured using the Medical Outcomes Study 36-item Short Form questionnaire (SF-36) with two additional questions on nausea, the Centre for Epidemiological Studies Depression Scale (CES-D), and the State-Trait Anxiety Inventory A-State Scale (STAI-S).
The patient groups were shown to be comparable at analysis in terms of a number of demographic features including age, gender and marital status.
Effectiveness results Patients who received the SSMT intervention had an improved quality of life over the course of chemotherapy treatment compared with UCO. This was significant in the SF-36 dimensions of summary mental health, physical function, vitality, role-emotional and mental health. There was also a statistically significant difference in improvement in the CES-D and STAI-S scores.
Patients who received the PSMT intervention had no statistically significant improvement in quality of life compared with UCO.
Clinical conclusions A SSMT scheme for oncology patients may improve quality of life for patients undergoing chemotherapy. The improvements are equivalent to those observed with a professionally administered scheme.
Modelling A regression analysis was performed to determine differential outcome trends of the three groups with time. Further, where significant (p<0.05) change over time was observed, additional statistical analyses were performed to explore this relationship.
Measure of benefits used in the economic analysis No summary health benefit was calculated. The study is therefore classified as a cost-consequences analysis.
Direct costs The included costs were relevant to a health-care payer. The costs were for a clinician/PhD-level therapist, a baccalaureate-level trainer, an overhead cost for clinician/PhD level therapist, baccalaureate-level trainer and "home". In addition, the costs of audiocassettes, brochures, video cassettes and blank audiotapes were included. The cost data were taken from the Medicare Fee schedule for 1999 to 2000, and from the authors' estimates. Discounting was irrelevant, as all costs were incurred in less than one year. The study reported the unit cost of each input, and a total cost of SSMT and PSMT. However, the authors did not explicitly show how much of each input was required for each arm.
In addition to calculating the cost of the interventions in the current study, the authors reported cost estimates from a number of other studies of similar professionally or self-administered programmes. The source of these costs was unclear, as were the method of calculation and price year.
Statistical analysis of costs No statistical analysis of the costs was performed.
Indirect Costs The authors included an opportunity cost for lost work time for patients. The justification being that it was required to estimate the societal costs of each intervention. This was imputed using the value of the minimum wage as a lower bound and the national mean wages for US workers in 2000 as an upper bound.
Sensitivity analysis No sensitivity analysis was reported.
Estimated benefits used in the economic analysis See the 'Effectiveness Results' section.
Cost results The SSMT arm costs $47 from the payer perspective and $73 from the societal perspective.
The PSMT arm costs $110 from the payer perspective and $136 from the societal perspective.
The authors averaged the cost of estimates of SSMT and PSMT from other studies. They reported that SSMT was, on average, $100 less expensive than PSMT from the payer perspective and $140 less expensive from the societal perspective.
Synthesis of costs and benefits Authors' conclusions The self-administered form of stress management training (SSMT) yielded similar quality of life improvements to the professionally administered stress management training (PSMT), but at lower cost.
CRD COMMENTARY - Selection of comparators The authors justified the use of the comparators they selected on the basis of a thorough review of the literature surrounding different psychosocial interventions to improve quality of life for patients undergoing chemotherapy. The control for the study was based on usual care in the authors' setting. You should decide whether it represents current practice in your setting.
Validity of estimate of measure of effectiveness The analysis used a randomised controlled trial, which was appropriate for the study question. The study sample appears to have been representative of the study population and the patient groups were shown to be comparable at analysis. Appropriate statistical analyses were carried out on the data.
Validity of estimate of measure of benefit The authors did not derive a summary measure of health benefit. The analysis was therefore classified as a cost-consequences analysis.
Validity of estimate of costs All the relevant categories of cost were included for the perspectives of the study (health-care payer and society). However, a significant omission was the cost of developing the resource package for the SSMT arm of the study. Thus, the cost of SSMT will have been underestimated, although as this is a fixed cost, the relative effect will be smaller the more the SSMT method is used.
The authors listed the unit costs of inputs into each of the arms. They also showed a total cost for each arm. Unfortunately, they did not show how much of each input was required for each arm. Therefore, there is insufficient information with which to evaluate the credibility of the cost estimates. A simple summary table showing the quantities and the costs in each arm would have enhanced the understanding of this section.
For some costs, the upper and lower bounds were quoted. This suggests the use of a sensitivity analysis to examine the impact of such costs. However, the results of this were not presented.
The resource use data were estimated from the description of the protocol for the SSMT and PSMT arms. No statistical analyses of the quantities or prices were reported. The price data related to the years 1999 to 2000.
The authors reported other cost estimates of interventions equivalent to SSMT and PSMT from published studies (see Other Publications of Related Interest). It was unclear how these were calculated. For example, whether they were based on the unit costs reported in this study, or the respective studies own cost estimates. It was also unclear whether the same price year had been used. Further, the authors stated that their version of PSMT differed from other studies 'in at least two ways', so the interventions are not truly comparable. Finally, the effectiveness of these other interventions was not reported. Taken together, these factors represent a serious limitation to the credibility of the assertion that "SSMT is (between) $100 and $140 less expensive (than PSMT)".
Other issues The authors made appropriate comparisons of their findings with those from other studies. In particular, they reported the surprising result that there was no significant difference in quality of life for patients in the PSMT or UCO arms, when other studies had shown improvements with PSMT. The explanation for this is that the PSMT form used by the authors differed from established relaxation training methods in at least two ways. First, the authors' intervention consisted of a single training session (other investigators had held up to 5 sessions). Second, the investigators did not include professionally guided relaxation sessions during the chemotherapy.
The issue of generalisability to other settings was not addressed. In addition, whilst the effectiveness data were thoroughly analysed and presented in depth, the authors appear to have presented their cost results superficially.
In summary, this was a thorough efficacy study, but the limited cost data restrict the usefulness of this study in decision-making. The authors compared effectiveness using their own study, which was a less resource-intensive and potentially less effective PSMT intervention of only one session. However, they compared costs with other studies that used more detailed PSMT techniques (up to 5 sessions) which, whilst they are invariably more resource-intensive, may also be more effective.
Implications of the study SSMT is an effective intervention in improving the quality of life of chemotherapy patients. It may be as effective as PSMT, yet can be delivered at lower cost.
Source of funding Supported by the National Cancer Institute, Bethesda (MD), grant number R01 CA70875; the American Cancer Society, Atlanta (GA), grant number PBR-99.
Bibliographic details Jacobsen P B, Meade C D, Stein K D, Chirikos T N, Small B J, Ruckdeschel J C. Efficacy and costs of two forms of stress management training for cancer patients undergoing chemotherapy. Journal of Clinical Oncology 2002; 20(12): 2851-2862 Other publications of related interest Carey MP, Burish TG. Providing relaxation training to cancer chemotherapy patients: a comparison of three delivery techniques. Journal of Consulting and Clinical Psychology 1989;55:732-7.
Burish TG, Carey MP, Krozely MG, et al. Conditioned side effects induced by cancer chemotherapy: prevention through behavioural treatment. Journal of Consulting and Clinical Psychology 1987;55:42-8.
Lerman C, Rimer B, Blumberg B, et al. Effects of coping style and relaxation on cancer chemotherapy side effects and emotional responses. Cancer Nursing 1990;13:308-15.
Walker LG, Walker MB, Ogston K, et al. Psychological, clinical, and pathological effects of relaxation training and guided imagery during primary chemotherapy. British Journal of Cancer 1999;80:262-8.
Burish TG, Snyder SL, RA Jenkins, et al. Preparing patients for cancer chemotherapy: effect of coping preparation and relaxation interventions. Journal of Consulting and Clinical Psychology 1991;59:518-25.
Indexing Status Subject indexing assigned by NLM MeSH Adult; Aged; Aged, 80 and over; Cost of Illness; Cost-Benefit Analysis; Female; Health Care Costs /statistics & Humans; Male; Middle Aged; Neoplasms /drug therapy /psychology; Quality of Life; Relaxation Therapy /economics; Self Care; Stress, Psychological /therapy; Treatment Outcome; numerical data AccessionNumber 22002001127 Date bibliographic record published 31/08/2003 Date abstract record published 31/08/2003 |
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