Claudia S E W Schuurhuizen1,2, Annemarie M J Braamse3, Aartjan T F Beekman2, Pim Cuijpers4, Mecheline H M van der Linden5, Adriaan W Hoogendoorn2, Hans Berkhof6, Dirkje W Sommeijer7, Vera Lustig7, Suzan Vrijaldenhoven8, Haiko J Bloemendal9, Cees J van Groeningen10, Annette A van Zweeden10, Maurice J D L van der Vorst11, Ron Rietbroek12, Cathrien S Tromp-van Driel13, Machteld N W Wymenga14, Peter W van der Linden15, Aart Beeker16, Marco B Polee17, Erdogan Batman18, Maartje Los19, Aart van Bochove20, Jan A C Brakenhoff21, Inge R H M Konings1, Henk M W Verheul1, Joost Dekker2. 1. Department of Medical Oncology, VU University Medical Center, Cancer Center Amsterdam, Amsterdam. 2. Department of Psychiatry and Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam. 3. Department of Medical Psychology, Cancer Center Amsterdam, Amsterdam Public Health Institute, Academic Medical Center, Amsterdam. 4. Department of Clinical Psychology, VU University, Amsterdam. 5. Department of Medical Psychology, and. 6. Department of Clinical Epidemiology and Biostatistics, VU University Medical Center, Amsterdam. 7. Department of Medical Oncology, Flevoziekenhuis, Almere. 8. Department of Medical Oncology, Noordwest Ziekenhuisgroep, Alkmaar. 9. Department of Medical Oncology, Meander Medical Center, Amersfoort. 10. Department of Medical Oncology, Hospital Amstelland, Amstelveen. 11. Department of Medical Oncology, Rijnstate Hospital, Arnhem. 12. Department of Medical Oncology, Red Cross Hospital, Beverwijk. 13. Department of Medical Oncology, Noordwest Ziekenhuisgroep, Den Helder. 14. Department of Medical Oncology, Medisch Spectrum Twente, Enschede. 15. Department of Medical Oncology, Spaarne Gasthuis, Haarlem. 16. Department of Medical Oncology, Spaarne Gasthuis, Hoofddorp. 17. Department of Medical Oncology, Medical Center Leeuwarden, Leeuwarden. 18. Department of Medical Oncology, Alrijne Hospital, Leiden. 19. Department of Medical Oncology, St. Antonius Hospital, Nieuwegein. 20. Department of Medical Oncology, Zaans Medical Center, Zaandam; and. 21. Department 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 theTES 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.
RCT Entities:
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.
Authors: Myra E van Linde; Annemarie M J Braamse; Emma H Collette; Adriaan W Hoogendoorn; Frank J Snoek; Henk M W Verheul; Joost Dekker Journal: Psychooncology Date: 2020-03-02 Impact factor: 3.894
Authors: Mohamed El Alili; Claudia S E W Schuurhuizen; Annemarie M J Braamse; Aartjan T F Beekman; Mecheline H van der Linden; Inge R Konings; Joost Dekker; Judith E Bosmans Journal: Palliat Med Date: 2020-04-29 Impact factor: 4.762
Authors: Angela R Bradbury; Ju-Whei Lee; Jill Bennett Gaieski; Shuli Li; Ilana F Gareen; Keith T Flaherty; Benjamin A Herman; Susan M Domchek; Angela M DeMichele; Kara N Maxwell; Adedayo A Onitilo; Shamsuddin Virani; SuJung Park; Bryan A Faller; Stefan C Grant; Ryan C Ramaekers; Robert J Behrens; Gopakumar S Nambudiri; Ruth C Carlos; Lynne I Wagner Journal: Cancer Date: 2021-12-10 Impact factor: 6.921
Authors: Hannah M Dragomanovich; Anand Dhruva; Eve Ekman; Kelly L Schoenbeck; Ai Kubo; Erin L Van Blarigan; Hala T Borno; Mikaela Esquivel; Bryant Chee; Matthew Campanella; Errol J Philip; John P Rettger; Blake Rosenthal; Katherine Van Loon; Alan P Venook; Christy Boscardin; Patricia Moran; Frederick M Hecht; Chloe E Atreya Journal: Glob Adv Health Med Date: 2021-11-03
Authors: Evie E M Kolsteren; Esther Deuning-Smit; Alanna K Chu; Yvonne C W van der Hoeven; Judith B Prins; Winette T A van der Graaf; Carla M L van Herpen; Inge M van Oort; Sophie Lebel; Belinda Thewes; Linda Kwakkenbos; José A E Custers Journal: Cancers (Basel) Date: 2022-08-11 Impact factor: 6.575