Screening and stepped care targeting psychological distress in patients with metastatic colorectal cancer: The TES cluster randomized trial

Claudia S. E. W. Schuurhuizen, Annemarie M. J. Braamse, Aartjan T. F. Beekman, Pim Cuijpers, Mecheline H. M. van der Linden, Adriaan W. Hoogendoorn, Hans Berkhof, Dirkje W. Sommeijer, Vera Lustig, Suzan Vrijaldenhoven, Haiko J. Bloemendal, Cees J. van Groeningen, Annette A. van Zweeden, Maurice J. D. L. van der Vorst, Ron Rietbroek, Cathrien S. Tromp-van Driel, MacHteld N. W. Wymenga, Peter W. van der Linden, Aart Beeker, Marco B. Polee & 7 others Erdogan Batman, Maartje Los, Aart van Bochove, Jan A. C. Brakenhoff, Inge R. H. M. Konings, Henk M. W. Verheul, Joost Dekker

Research output: Contribution to journalArticleAcademicpeer-review

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. Linearmixedmodels 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.
Original languageEnglish
Pages (from-to)911-920
JournalJournal of the national comprehensive cancer network
Volume17
Issue number8
DOIs
Publication statusPublished - 2019

Cite this

Schuurhuizen, Claudia S. E. W. ; Braamse, Annemarie M. J. ; Beekman, Aartjan T. F. ; Cuijpers, Pim ; van der Linden, Mecheline H. M. ; Hoogendoorn, Adriaan W. ; Berkhof, Hans ; Sommeijer, Dirkje W. ; Lustig, Vera ; Vrijaldenhoven, Suzan ; Bloemendal, Haiko J. ; van Groeningen, Cees J. ; van Zweeden, Annette A. ; van der Vorst, Maurice J. D. L. ; Rietbroek, Ron ; Tromp-van Driel, Cathrien S. ; Wymenga, MacHteld N. W. ; van der Linden, Peter W. ; Beeker, Aart ; Polee, Marco B. ; Batman, Erdogan ; Los, Maartje ; van Bochove, Aart ; Brakenhoff, Jan A. C. ; Konings, Inge R. H. M. ; Verheul, Henk M. W. ; Dekker, Joost. / Screening and stepped care targeting psychological distress in patients with metastatic colorectal cancer: The TES cluster randomized trial. In: Journal of the national comprehensive cancer network. 2019 ; Vol. 17, No. 8. pp. 911-920.
@article{530cbbc640e94302a8ad2b4fe9a62c0c,
title = "Screening and stepped care targeting psychological distress in patients with metastatic colorectal cancer: The TES cluster randomized trial",
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. Linearmixedmodels 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.",
author = "Schuurhuizen, {Claudia S. E. W.} and Braamse, {Annemarie M. J.} and Beekman, {Aartjan T. F.} and Pim Cuijpers and {van der Linden}, {Mecheline H. M.} and Hoogendoorn, {Adriaan W.} and Hans Berkhof and Sommeijer, {Dirkje W.} and Vera Lustig and Suzan Vrijaldenhoven and Bloemendal, {Haiko J.} and {van Groeningen}, {Cees J.} and {van Zweeden}, {Annette A.} and {van der Vorst}, {Maurice J. D. L.} and Ron Rietbroek and {Tromp-van Driel}, {Cathrien S.} and Wymenga, {MacHteld N. W.} and {van der Linden}, {Peter W.} and Aart Beeker and Polee, {Marco B.} and Erdogan Batman and Maartje Los and {van Bochove}, Aart and Brakenhoff, {Jan A. C.} and Konings, {Inge R. H. M.} and Verheul, {Henk M. W.} and Joost Dekker",
year = "2019",
doi = "10.6004/jnccn.2019.7285",
language = "English",
volume = "17",
pages = "911--920",
journal = "Journal of the national comprehensive cancer network",
issn = "1540-1405",
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number = "8",

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Schuurhuizen, CSEW, Braamse, AMJ, Beekman, ATF, Cuijpers, P, van der Linden, MHM, Hoogendoorn, AW, Berkhof, H, Sommeijer, DW, Lustig, V, Vrijaldenhoven, S, Bloemendal, HJ, van Groeningen, CJ, van Zweeden, AA, van der Vorst, MJDL, Rietbroek, R, Tromp-van Driel, CS, Wymenga, MNW, van der Linden, PW, Beeker, A, Polee, MB, Batman, E, Los, M, van Bochove, A, Brakenhoff, JAC, Konings, IRHM, Verheul, HMW & Dekker, J 2019, 'Screening and stepped care targeting psychological distress in patients with metastatic colorectal cancer: The TES cluster randomized trial' Journal of the national comprehensive cancer network, vol. 17, no. 8, pp. 911-920. https://doi.org/10.6004/jnccn.2019.7285

Screening and stepped care targeting psychological distress in patients with metastatic colorectal cancer: The TES cluster randomized trial. / Schuurhuizen, Claudia S. E. W.; Braamse, Annemarie M. J.; Beekman, Aartjan T. F.; Cuijpers, Pim; van der Linden, Mecheline H. M.; Hoogendoorn, Adriaan W.; Berkhof, Hans; Sommeijer, Dirkje W.; Lustig, Vera; Vrijaldenhoven, Suzan; Bloemendal, Haiko J.; van Groeningen, Cees J.; van Zweeden, Annette A.; van der Vorst, Maurice J. D. L.; Rietbroek, Ron; Tromp-van Driel, Cathrien S.; Wymenga, MacHteld N. W.; van der Linden, Peter W.; Beeker, Aart; Polee, Marco B.; Batman, Erdogan; Los, Maartje; van Bochove, Aart; Brakenhoff, Jan A. C.; Konings, Inge R. H. M.; Verheul, Henk M. W.; Dekker, Joost.

In: Journal of the national comprehensive cancer network, Vol. 17, No. 8, 2019, p. 911-920.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Screening and stepped care targeting psychological distress in patients with metastatic colorectal cancer: The TES cluster randomized trial

AU - Schuurhuizen, Claudia S. E. W.

AU - Braamse, Annemarie M. J.

AU - Beekman, Aartjan T. F.

AU - Cuijpers, Pim

AU - van der Linden, Mecheline H. M.

AU - Hoogendoorn, Adriaan W.

AU - Berkhof, Hans

AU - Sommeijer, Dirkje W.

AU - Lustig, Vera

AU - Vrijaldenhoven, Suzan

AU - Bloemendal, Haiko J.

AU - van Groeningen, Cees J.

AU - van Zweeden, Annette A.

AU - van der Vorst, Maurice J. D. L.

AU - Rietbroek, Ron

AU - Tromp-van Driel, Cathrien S.

AU - Wymenga, MacHteld N. W.

AU - van der Linden, Peter W.

AU - Beeker, Aart

AU - Polee, Marco B.

AU - Batman, Erdogan

AU - Los, Maartje

AU - van Bochove, Aart

AU - Brakenhoff, Jan A. C.

AU - Konings, Inge R. H. M.

AU - Verheul, Henk M. W.

AU - Dekker, Joost

PY - 2019

Y1 - 2019

N2 - 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. Linearmixedmodels 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.

AB - 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. Linearmixedmodels 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.

UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85071908112&origin=inward

UR - https://www.ncbi.nlm.nih.gov/pubmed/31390590

U2 - 10.6004/jnccn.2019.7285

DO - 10.6004/jnccn.2019.7285

M3 - Article

VL - 17

SP - 911

EP - 920

JO - Journal of the national comprehensive cancer network

JF - Journal of the national comprehensive cancer network

SN - 1540-1405

IS - 8

ER -