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Effect of general practitioner-led versus surgeon-led colon cancer survivorship care, with or without eHealth support, on quality of life (I CARE): an interim analysis of 1-year results of a randomised, controlled trial - 31/07/21

Doi : 10.1016/S1470-2045(21)00273-4 
Julien A M Vos, MD a, c, , Laura A M Duineveld, MD a, Thijs Wieldraaijer, PhD a, Jan Wind, PhD a, Wim B Busschers, MSc a, Edanur Sert, MSc a, Pieter J Tanis, ProfPhD b, d, Irma M Verdonck-de Leeuw, ProfPhD c, d, e, Henk C P M van Weert, ProfPhD a, c, Kristel M van Asselt, PhD a, c
on behalf of the

I CARE study group

  Members listed in the Supplementary Material

a Department of General Practice, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands 
b Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands 
c Amsterdam Public Health Research Institute, Amsterdam UMC, Amsterdam, Netherlands 
d Cancer Centre Amsterdam, Amsterdam UMC, Amsterdam, Netherlands 
e Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, and Department of Clinical, Neuro- and Developmental Psychology (Clinical Psychology Section), Vrije Universiteit Amsterdam, Amsterdam, Netherlands 

* Correspondence to: Dr Julien A M Vos, Department of General Practice, Amsterdam UMC, 1100 DD Amsterdam, Netherlands Department of General Practice Amsterdam UMC Amsterdam DD 1100 Netherlands

Summary

Background

Colon cancer is associated with an increased risk of physical and psychosocial morbidity, even after treatment. General practitioner (GP) care could be beneficial to help to reduce this morbidity. We aimed to assess quality of life (QOL) in patients who received GP-led survivorship care after treatment for colon cancer compared with those who received surgeon-led care. Furthermore, the effect of an eHealth app (Oncokompas) on QOL was assessed in both patient groups.

Methods

We did a pragmatic two-by-two factorial, open-label, randomised, controlled trial at eight hospitals in the Netherlands. Eligible patients were receiving primary surgical treatment for stage I–III colon cancer or rectosigmoid carcinoma and qualified for routine follow-up according to Dutch national guidelines. Patients were randomly assigned (1:1:1:1)—via computer-generated variable block randomisation stratified by age and tumour stage—to survivorship care overseen by a surgeon, survivorship care overseen by a surgeon with access to Oncokompas, survivorship care overseen by a GP, or survivorship care overseen by a GP with access to Oncokompas. Blinding of the trial was not possible. The primary endpoint of the trial was QOL at 5 years, as measured by the change from baseline in the European Organistion for Research and Treatment of Cancer QLQ-C30 summary score. Here, we report an unplanned interim analysis of QOL at the 12-month follow-up. Grouped comparisons were done (ie, both GP-led care groups were compared with both surgeon-led groups, and both Oncokompas groups were compared with both no Oncokompas groups). Differences in change of QOL between trial groups were estimated with linear mixed-effects models. A change of ten units was considered clinically meaningful. Analysis was by intention to treat. This trial is registered with the Netherlands Trial Register, NTR4860.

Findings

Between March 26, 2015, and Nov 21, 2018, 353 patients were enrolled and randomly assigned. There were 50 early withdrawals (27 patient decisions and 23 GP withdrawals). Of the remaining 303 participants, 79 were assigned to surgeon-led care, 83 to surgeon-led care with Oncokompas, 73 to GP-led care, and 68 to GP-led care with Oncokompas. Median follow-up was 12·2 months (IQR 12·0–13·0) in all groups. At baseline, QOL was high in all trial groups. At 12 months, there was no clinically meaningful difference in change from baseline in QOL between the GP-led care groups and the surgeon-led care groups (difference in summary score –2·3 [95% CI –5·0 to 0·4]) or between the Oncokompas and no Oncokompas groups (−0·1 [–2·8 to 2·6]).

Interpretation

In terms of QOL, GP-led survivorship care can be considered as an alternative to surgeon-led care within the first year after colon cancer treatment. Other outcomes, including patient and physician preferences, will be important for decisions about the type of survivorship care.

Funding

Dutch Cancer Society (KWF).

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Vol 22 - N° 8

P. 1175-1187 - août 2021 Retour au numéro
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