The MELFO Study: A Multicenter, Prospective, Randomized Clinical Trial on the Effects of a Reduced Stage-Adjusted Follow-Up Schedule on Cutaneous Melanoma IB–IIC Patients—Results After 3 Years
| Autor: | Josette E. H. M. Hoekstra-Weebers, Sylvia ter Meulen, Esther Bastiaannet, Eric A. Deckers, Harald J. Hoekstra, Samantha Damude, Anne Brecht Francken |
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| Přispěvatelé: | Health Psychology Research (HPR) |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Skin Neoplasms Cost-Benefit Analysis General Practice Aftercare law.invention 030207 dermatology & venereal diseases 03 medical and health sciences Young Adult 0302 clinical medicine Randomized controlled trial law Internal medicine Ambulatory Care Medicine Humans Patient Reported Outcome Measures Young adult Hospital Costs Mortality RECURRENCE Melanoma Aged Neoplasm Staging Netherlands Proportional Hazards Models Aged 80 and over business.industry Proportional hazards model Hazard ratio Repeated measures design Guideline Health Care Costs Middle Aged Regimen Oncology 030220 oncology & carcinogenesis Cutaneous melanoma Practice Guidelines as Topic Quality of Life Surgery Female Neoplasm Recurrence Local business |
| Zdroj: | Annals of Surgical Oncology Annals of Surgical Oncology, 27(5), 1407-1417. SPRINGER |
| ISSN: | 1534-4681 1068-9265 |
| Popis: | Background This study compares well-being, recurrences, and deaths of early-stage cutaneous melanoma patients in follow-up, as recommended in the Dutch guideline, with that of patients in a stage-adjusted reduced follow-up schedule, 3 years after diagnosis, as well as costs. Methods Overall, 180 eligible pathological American Joint Committee on Cancer (AJCC) stage IB–IIC, sentinel node staged, melanoma patients (response rate = 87%, 48% male, median age 57 years), randomized into a conventional (CSG, n = 93) or experimental (ESG, n = 87) follow-up schedule group, completed patient-reported outcome measures (PROMs) at diagnosis (T1): State-Trait Anxiety Inventory–State version (STAI-S), Cancer Worry Scale (CWS), Impact of Event Scale (IES), and RAND-36 (Mental and Physical Component scales [PCS/MCS]). Three years later (T3), 110 patients (CSG, n = 56; ESG, n = 54) completed PROMs, while 42 declined (23%). Results Repeated measures analyses of variance (ANOVAs) showed a significant group effect on the IES (p = 0.001) in favor of the ESG, and on the RAND-36 PCS (p = 0.02) favoring the CSG. Mean IES and CWS scores decreased significantly over time, while those on the RAND-36 MCS and PCS increased. Effect sizes were small. Twenty-five patients developed a recurrence or second primary melanoma, of whom 13 patients died within 3 years. Cox proportional hazards models showed no differences between groups in recurrence-free survival (hazard ratio [HR] 0.71 [0.32–1.58]; p = 0.400) and disease-free survival (HR 1.24 [0.42–3.71]; p = 0.690). Costs per patient after 3 years (computed for 77.3% of patients) were 39% lower in the ESG. Conclusion These results seemingly support the notion that a stage-adjusted reduced follow-up schedule forms an appropriate, safe, and cost-effective alternative for pathological AJCC stage IB–IIC melanoma patients to the follow-up regimen as advised in the current melanoma guideline. |
| Databáze: | OpenAIRE |
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