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


CONCLUSIONS
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.
Passalacqua
Rodolfo
R
Division of Medical Oncology, Istituti Ospitalieri, Cremona, Italy. r.passalacqua@ospedale.cremona.it
Caminiti
Caterina
C
Campione
Francesco
F
Diodati
Francesca
F
Todeschini
Renata
R
Bisagni
Giancarlo
G
Labianca
Roberto
R
Dalla Chiesa
Matteo
M
Bracci
Raffaella
R
Aragona
Marcello
M
Artioli
Fabrizio
F
Cavanna
Luigi
L
Masina
Alceste
A
De Falco
Francesco
F
Marzocchini
Barbara
B
Iacono
Carmelo
C
Contu
Antonio
A
Di Costanzo
Francesco
F
Bertetto
Oscar
O
Annunziata
Maria A
MA
D005260:Female; D006266:Health Education; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000523:psychology* / Q000628:therapy*; D009723:Nurse-Patient Relations; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D010817:Physician-Patient Relations; D011446:Prospective Studies; D012944:Social Support; D013315:Stress, Psychological; D011795:Surveys and Questionnaires