Prospective, multicenter, randomized trial of a new organizational modality for providing information and support to cancer patients

Rodolfo Passalacqua, Caterina Caminiti, Francesco Campione, Francesca Diodati, Renata Todeschini, Giancarlo Bisagni, Roberto Labianca, Matteo Dalla Chiesa, Raffaella Bracci, Marcello Aragona, Fabrizio Artioli, Luigi Cavanna, Alceste Masina, Francesco De Falco, Barbara Marzocchini, Carmelo Iacono, Antonio Contu, Francesco Di Costanzo, Oscar Bertetto, Maria A. Annunziata

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Purpose No structured modality for providing information and support to patients in oncology wards has been validated in clinical trials. Methods This is a pragmatic, two-arm, cluster randomized trial, with the oncology ward as random assignment unit. Centers were allocated to implement a Point of Information and Support (PIS) or to a control group. The PIS included a library for cancer patients and a specifically trained oncology nurse. End points, measured at patient level, were psychological distress and satisfaction with received information. Both intent-to-treat and per-protocol analyses considering clustering were performed. Results Thirty-eight Italian cancer centers were randomly assigned, and 6 months after PIS creation, 3,286 unselected, consecutive cancer patients were surveyed (1,654 in the experimental group and 1,632 in the control group). Three thousand one hundred ninety-seven (97%) questionnaires were collected and deemed valid. Fifty-two percent of centers (11 of 21 centers) in the experimental arm did not implement the PIS in accordance with the protocol. Overall, 34% of patients showed moderate to severe psychological distress, and only 9% declared dissatisfaction. Intent-to-treat analysis did not yield significant differences. Although the per-protocol analysis did show a reduction in psychological distress (28.9% for functioning PIS v 33.3% for no PIS) and dissatisfaction (6.4% for functioning PIS v 9.3% for no PIS), differences did not reach significance. Conclusion This is the first cluster randomized trial aiming to demonstrate that a structured modality of providing information reduces psychological distress. We did not find this, but we believe results should be interpreted cautiously, particularly because of the low compliance with PIS implementation. Context analysis preceding such interventions is essential.

Original languageEnglish
Pages (from-to)1794-1799
Number of pages6
JournalJournal of Clinical Oncology
Volume27
Issue number11
DOIs
Publication statusPublished - Apr 10 2009

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Multicenter Studies
Psychology
Neoplasms
Control Groups
Libraries
Cluster Analysis
Nurses
Clinical Trials

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Prospective, multicenter, randomized trial of a new organizational modality for providing information and support to cancer patients. / Passalacqua, Rodolfo; Caminiti, Caterina; Campione, Francesco; Diodati, Francesca; Todeschini, Renata; Bisagni, Giancarlo; Labianca, Roberto; Chiesa, Matteo Dalla; Bracci, Raffaella; Aragona, Marcello; Artioli, Fabrizio; Cavanna, Luigi; Masina, Alceste; De Falco, Francesco; Marzocchini, Barbara; Iacono, Carmelo; Contu, Antonio; Costanzo, Francesco Di; Bertetto, Oscar; Annunziata, Maria A.

In: Journal of Clinical Oncology, Vol. 27, No. 11, 10.04.2009, p. 1794-1799.

Research output: Contribution to journalArticle

Passalacqua, R, Caminiti, C, Campione, F, Diodati, F, Todeschini, R, Bisagni, G, Labianca, R, Chiesa, MD, Bracci, R, Aragona, M, Artioli, F, Cavanna, L, Masina, A, De Falco, F, Marzocchini, B, Iacono, C, Contu, A, Costanzo, FD, Bertetto, O & Annunziata, MA 2009, 'Prospective, multicenter, randomized trial of a new organizational modality for providing information and support to cancer patients', Journal of Clinical Oncology, vol. 27, no. 11, pp. 1794-1799. https://doi.org/10.1200/JCO.2007.15.0615
Passalacqua, Rodolfo ; Caminiti, Caterina ; Campione, Francesco ; Diodati, Francesca ; Todeschini, Renata ; Bisagni, Giancarlo ; Labianca, Roberto ; Chiesa, Matteo Dalla ; Bracci, Raffaella ; Aragona, Marcello ; Artioli, Fabrizio ; Cavanna, Luigi ; Masina, Alceste ; De Falco, Francesco ; Marzocchini, Barbara ; Iacono, Carmelo ; Contu, Antonio ; Costanzo, Francesco Di ; Bertetto, Oscar ; Annunziata, Maria A. / Prospective, multicenter, randomized trial of a new organizational modality for providing information and support to cancer patients. In: Journal of Clinical Oncology. 2009 ; Vol. 27, No. 11. pp. 1794-1799.
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abstract = "Purpose No structured modality for providing information and support to patients in oncology wards has been validated in clinical trials. Methods This is a pragmatic, two-arm, cluster randomized trial, with the oncology ward as random assignment unit. Centers were allocated to implement a Point of Information and Support (PIS) or to a control group. The PIS included a library for cancer patients and a specifically trained oncology nurse. End points, measured at patient level, were psychological distress and satisfaction with received information. Both intent-to-treat and per-protocol analyses considering clustering were performed. Results Thirty-eight Italian cancer centers were randomly assigned, and 6 months after PIS creation, 3,286 unselected, consecutive cancer patients were surveyed (1,654 in the experimental group and 1,632 in the control group). Three thousand one hundred ninety-seven (97{\%}) questionnaires were collected and deemed valid. Fifty-two percent of centers (11 of 21 centers) in the experimental arm did not implement the PIS in accordance with the protocol. Overall, 34{\%} of patients showed moderate to severe psychological distress, and only 9{\%} declared dissatisfaction. Intent-to-treat analysis did not yield significant differences. Although the per-protocol analysis did show a reduction in psychological distress (28.9{\%} for functioning PIS v 33.3{\%} for no PIS) and dissatisfaction (6.4{\%} for functioning PIS v 9.3{\%} for no PIS), differences did not reach significance. Conclusion This is the first cluster randomized trial aiming to demonstrate that a structured modality of providing information reduces psychological distress. We did not find this, but we believe results should be interpreted cautiously, particularly because of the low compliance with PIS implementation. Context analysis preceding such interventions is essential.",
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AU - Passalacqua, Rodolfo

AU - Caminiti, Caterina

AU - Campione, Francesco

AU - Diodati, Francesca

AU - Todeschini, Renata

AU - Bisagni, Giancarlo

AU - Labianca, Roberto

AU - Chiesa, Matteo Dalla

AU - Bracci, Raffaella

AU - Aragona, Marcello

AU - Artioli, Fabrizio

AU - Cavanna, Luigi

AU - Masina, Alceste

AU - De Falco, Francesco

AU - Marzocchini, Barbara

AU - Iacono, Carmelo

AU - Contu, Antonio

AU - Costanzo, Francesco Di

AU - Bertetto, Oscar

AU - Annunziata, Maria A.

PY - 2009/4/10

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N2 - Purpose No structured modality for providing information and support to patients in oncology wards has been validated in clinical trials. Methods This is a pragmatic, two-arm, cluster randomized trial, with the oncology ward as random assignment unit. Centers were allocated to implement a Point of Information and Support (PIS) or to a control group. The PIS included a library for cancer patients and a specifically trained oncology nurse. End points, measured at patient level, were psychological distress and satisfaction with received information. Both intent-to-treat and per-protocol analyses considering clustering were performed. Results Thirty-eight Italian cancer centers were randomly assigned, and 6 months after PIS creation, 3,286 unselected, consecutive cancer patients were surveyed (1,654 in the experimental group and 1,632 in the control group). Three thousand one hundred ninety-seven (97%) questionnaires were collected and deemed valid. Fifty-two percent of centers (11 of 21 centers) in the experimental arm did not implement the PIS in accordance with the protocol. Overall, 34% of patients showed moderate to severe psychological distress, and only 9% declared dissatisfaction. Intent-to-treat analysis did not yield significant differences. Although the per-protocol analysis did show a reduction in psychological distress (28.9% for functioning PIS v 33.3% for no PIS) and dissatisfaction (6.4% for functioning PIS v 9.3% for no PIS), differences did not reach significance. Conclusion This is the first cluster randomized trial aiming to demonstrate that a structured modality of providing information reduces psychological distress. We did not find this, but we believe results should be interpreted cautiously, particularly because of the low compliance with PIS implementation. Context analysis preceding such interventions is essential.

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