Screening and Stepped Care Targeting Psychological Distress in Patients With Metastatic Colorectal Cancer: The TES Cluster Randomized Trial

Author:

Schuurhuizen Claudia S.E.W.12,Braamse Annemarie M.J.3,Beekman Aartjan T.F.2,Cuijpers Pim4,van der Linden Mecheline H.M.5,Hoogendoorn Adriaan W.2,Berkhof Hans6,Sommeijer Dirkje W.7,Lustig Vera7,Vrijaldenhoven Suzan8,Bloemendal Haiko J.9,van Groeningen Cees J.10,van Zweeden Annette A.10,van der Vorst Maurice J.D.L.11,Rietbroek Ron12,Tromp-van Driel Cathrien S.13,Wymenga Machteld N.W.14,van der Linden Peter W.15,Beeker Aart16,Polee Marco B.17,Batman Erdogan18,Los Maartje19,van Bochove Aart20,Brakenhoff Jan A.C.21,Konings Inge R.H.M.1,Verheul Henk M.W.1,Dekker Joost2

Affiliation:

1. aDepartment of Medical Oncology, VU University Medical Center, Cancer Center Amsterdam, Amsterdam;

2. bDepartment of Psychiatry and Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam;

3. cDepartment of Medical Psychology, Cancer Center Amsterdam, Amsterdam Public Health Institute, Academic Medical Center, Amsterdam;

4. dDepartment of Clinical Psychology, VU University, Amsterdam;

5. eDepartment of Medical Psychology, and

6. fDepartment of Clinical Epidemiology and Biostatistics, VU University Medical Center, Amsterdam;

7. gDepartment of Medical Oncology, Flevoziekenhuis, Almere;

8. hDepartment of Medical Oncology, Noordwest Ziekenhuisgroep, Alkmaar;

9. iDepartment of Medical Oncology, Meander Medical Center, Amersfoort;

10. jDepartment of Medical Oncology, Hospital Amstelland, Amstelveen;

11. kDepartment of Medical Oncology, Rijnstate Hospital, Arnhem;

12. lDepartment of Medical Oncology, Red Cross Hospital, Beverwijk;

13. mDepartment of Medical Oncology, Noordwest Ziekenhuisgroep, Den Helder;

14. nDepartment of Medical Oncology, Medisch Spectrum Twente, Enschede;

15. oDepartment of Medical Oncology, Spaarne Gasthuis, Haarlem;

16. pDepartment of Medical Oncology, Spaarne Gasthuis, Hoofddorp;

17. qDepartment of Medical Oncology, Medical Center Leeuwarden, Leeuwarden;

18. rDepartment of Medical Oncology, Alrijne Hospital, Leiden;

19. sDepartment of Medical Oncology, St. Antonius Hospital, Nieuwegein;

20. tDepartment of Medical Oncology, Zaans Medical Center, Zaandam; and

21. uDepartment of Medical Oncology, Waterland Hospital, Purmerend, the Netherlands.

Abstract

Background: This study evaluated the effectiveness of a screening and stepped care program (the TES program) in reducing psychological distress compared with care as usual (CAU) in patients with metastatic colorectal cancer starting with first-line systemic palliative treatment. Patients and Methods: In this cluster randomized trial, 16 hospitals were assigned to the TES program or CAU. Patients in the TES arm were screened for psychological distress with the Hospital Anxiety and Depression Scale and the Distress Thermometer/Problem List (at baseline and 10 and 18 weeks). Stepped care was offered to patients with distress or expressed needs, and it consisted of watchful waiting, guided self-help, face-to-face problem-solving therapy, or referral to specialized mental healthcare. The primary outcome was change in psychological distress over time, and secondary outcomes were quality of life, satisfaction with care, and recognition and referral of distressed patients by clinicians. Linear mixed models and effect sizes were used to evaluate differences. Results: A total of 349 patients were randomized; 184 received the TES program and 165 received CAU. In the TES arm, 60.3% of the patients screened positive for psychological distress, 26.1% of which entered the stepped care program (14.7% used only watchful waiting and 11.4% used at least one of the other treatment steps). The observed low use of the TES program led us to pursue a futility analysis, which showed a small conditional power and therefore resulted in halted recruitment for this study. No difference was seen in change in psychological distress over time between the 2 groups (effect size, −0.16; 95% CI, −0.35 to 0.03; P>.05). The TES group reported higher satisfaction with the received treatment and better cognitive quality of life (all P<.05). Conclusions: As a result of the low use of stepped care, a combined screening and treatment program targeting psychological distress in patients with metastatic colorectal cancer did not improve psychological distress. Our results suggest that enhanced evaluation of psychosocial concerns may improve aspects of patient well-being.

Publisher

Harborside Press, LLC

Subject

Oncology

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