Cost-effectiveness of an exercise and nutritional intervention versus usual nutritional care during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial

Abstract

We undertook a cost-effectiveness analysis (CEA) to compare an exercise and nutritional program with the usual nutritional care concomitant to adjuvant chemotherapy in localized breast cancer patients. The CEA was designed as part of the interventional, controlled, randomized, single-center, open-label PASAPAS study. Breast cancer patients receiving first-line adjuvant chemotherapy at a French Comprehensive Cancer Center were randomized 2:1 to a 6-month exercise program of supervised indoor and outdoor group sessions in addition to usual nutritional care (exercise arm) or a usual nutritional care group receiving dietary and physical activity counseling (control arm). Costs were assessed from the French national insurance perspective (in Euros, 2012). Incremental cost-effectiveness ratios (ICERs) were calculated for four criteria: body mass index, waist circumference, body fat percentage, and estimated aerobic capacity. Uncertainty around the ICERs was captured by a probabilistic analysis using a non-parametric bootstrap method. The analysis was based on 60 patients enrolled between 2011 and 2013. Average intervention costs per participant were €412 in the exercise arm (n = 41) and €117 (n = 19) in the control arm. Total mean costs were €17,344 (standard deviation 9,928) and €20,615 (standard deviation 14,904), respectively, did not differ significantly (p = 0.51). The 6-month exercise program was deemed to be cost-effective compared with usual care for the estimated aerobic capacity. Multicenter randomized studies with long-term costs and outcomes should be done to provide additional evidence. Clinical trial: The PASAPAS study is registered under ClinicalTrials.gov. Trial registration ID: NCT01331772.

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Abbreviations

BMI:

body mass index

CEA:

cost-effectiveness analysis

DRG:

diagnosis-related group

ICERs:

incremental cost-effectiveness ratios

HAS:

National Authority for Health

PA:

physical activity

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Funding

The authors received funding from the French Institut National du Cancer (2010-228/VO-HO), the Ligue contre le cancer (PME 2010-2011), the Fondation de France (2010-15024), the Association Nationale de la Recherche et de la Technologie (CIFRE/ANRT no. 426/2010) and the Cancéropôle Lyon Auvergne Rhône-Alpes (Programme structurant 2010).

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Correspondence to Lionel Perrier.

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Conflict of interest

The authors declare that they have no conflicts of interest.

Ethical approval

This study was approved by the French Ethics Committee (Comité de Protection des Personnes Sud-Est IV, No.11-023), the National Security Agency of Medicines and Health Products that applies for biomedical studies (Agence Nationale de Sécurité du Médicament et des produits de santé, No.B110268-80), and the French National Committee on Informatics and Privacy (Commission Nationale de l’Informatique et des Libertés).

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Informed consent was obtained from all individual participants included in the study.

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Novelty and impact

A cost-effectiveness analysis was designed as part of the interventional, controlled, randomized, single-center, open-label PASAPAS study to compare a 6-month exercise program versus usual nutritional care concomitant to adjuvant chemotherapy in localized breast cancer patients. Incremental cost-effectiveness ratios (ICERs) were calculated for body mass index, waist circumference, body fat percentage, and estimated aerobic capacity. The exercise program was deemed to be cost-effective compared with usual nutritional care for the estimated aerobic capacity.

Appendices

Appendix 1

Table 4 Sociodemographic and clinical characteristics of the patients of the PASAPAS trial at baseline according to randomization arm (N = 60)
Table 5 Nutritional characteristics (anthropometrics, body composition, physical activity, sedentary behavior, diet, lipid, and glycaemic profile) of the patients of the PASAPAS trial at baseline according to randomization arms (N = 60)

Appendix 2

Table 6 Mean time (SD) (in minutes) required from staff for consultations in the physical activity (PA) intervention and control arms

Appendix 3

Table 7 Unit costs and prices

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Perrier, L., Foucaut, AM., Morelle, M. et al. Cost-effectiveness of an exercise and nutritional intervention versus usual nutritional care during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial. Support Care Cancer 28, 2829–2842 (2020). https://doi.org/10.1007/s00520-019-05078-4

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Keywords

  • Breast cancer
  • Cost-effectiveness analysis
  • Physical activity
  • Dietary care