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PREPARE: PreoPerative Anxiety REduction. One-Year Feasibility RCT on a Brief Psychological Intervention for Pancreatic Cancer Patients Prior to Major Surgery
INTRODUCTION: The aim of the present paper is to establish feasibility and required power of a one-session psychological intervention devoted to increasing patient’s self-efficacy and awareness in dealing with anxiety symptoms before major pancreatic cancer surgery. METHODS: Parallel assignment RCT....
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7066303/ https://www.ncbi.nlm.nih.gov/pubmed/32194490 http://dx.doi.org/10.3389/fpsyg.2020.00362 |
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author | Marinelli, Veronica Danzi, Olivia Purnima Mazzi, Maria Angela Secchettin, Erica Tuveri, Massimiliano Bonamini, Deborah Rimondini, Michela Salvia, Roberto Bassi, Claudio Del Piccolo, Lidia |
author_facet | Marinelli, Veronica Danzi, Olivia Purnima Mazzi, Maria Angela Secchettin, Erica Tuveri, Massimiliano Bonamini, Deborah Rimondini, Michela Salvia, Roberto Bassi, Claudio Del Piccolo, Lidia |
author_sort | Marinelli, Veronica |
collection | PubMed |
description | INTRODUCTION: The aim of the present paper is to establish feasibility and required power of a one-session psychological intervention devoted to increasing patient’s self-efficacy and awareness in dealing with anxiety symptoms before major pancreatic cancer surgery. METHODS: Parallel assignment RCT. All consenting patients listed for pancreatic major surgery during day-hospital visits (T0) between June 2017–June 2018 were assigned randomly in blocks of ten to a psychological intervention vs usual care group to be held the day before surgery (T1). The psychological intervention provided the patient the opportunity to increase self-efficacy in dealing with anxiety by talking with a psychologist about personal concerns and learning mindfulness based techniques to cope with anxiety. RESULTS: 400 patients were randomized into the experimental vs. usual care group. 49 and 65, respectively, completed baseline and post-intervention measures. The dropout rate between day-hospital (T0) and pre-surgery intervention (T1) was high (74.5%) due to several management and organization pitfalls. The main outcome, perceived self-efficacy in managing anxiety, showed a significant increase in the intervention group compared to the control group (p < 0.001), and was related to a reduction in state anxiety (p < 0.001). The intervention group perceived also lower emotional pain (p = 0.03). A power analysis was performed to define the appropriate sample size in a definitive RCT. CONCLUSION: Beneath the complexity in retaining patients along their trajectory in pancreatic surgery department, when they had the opportunity to follow a brief psychological intervention, most of them adhered, showing a significant reduction in preoperative emotional distress and less emotional pain perception after surgery. Even if results need caution because of the high attrition rate, we can infer that our psychological intervention has the potential to be proposed in surgical setting, being short, easy to learn and applicable to a wide range of patients. CLINICAL TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov (identifier: NCT03408002). The full protocol is available from the last author. |
format | Online Article Text |
id | pubmed-7066303 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-70663032020-03-19 PREPARE: PreoPerative Anxiety REduction. One-Year Feasibility RCT on a Brief Psychological Intervention for Pancreatic Cancer Patients Prior to Major Surgery Marinelli, Veronica Danzi, Olivia Purnima Mazzi, Maria Angela Secchettin, Erica Tuveri, Massimiliano Bonamini, Deborah Rimondini, Michela Salvia, Roberto Bassi, Claudio Del Piccolo, Lidia Front Psychol Psychology INTRODUCTION: The aim of the present paper is to establish feasibility and required power of a one-session psychological intervention devoted to increasing patient’s self-efficacy and awareness in dealing with anxiety symptoms before major pancreatic cancer surgery. METHODS: Parallel assignment RCT. All consenting patients listed for pancreatic major surgery during day-hospital visits (T0) between June 2017–June 2018 were assigned randomly in blocks of ten to a psychological intervention vs usual care group to be held the day before surgery (T1). The psychological intervention provided the patient the opportunity to increase self-efficacy in dealing with anxiety by talking with a psychologist about personal concerns and learning mindfulness based techniques to cope with anxiety. RESULTS: 400 patients were randomized into the experimental vs. usual care group. 49 and 65, respectively, completed baseline and post-intervention measures. The dropout rate between day-hospital (T0) and pre-surgery intervention (T1) was high (74.5%) due to several management and organization pitfalls. The main outcome, perceived self-efficacy in managing anxiety, showed a significant increase in the intervention group compared to the control group (p < 0.001), and was related to a reduction in state anxiety (p < 0.001). The intervention group perceived also lower emotional pain (p = 0.03). A power analysis was performed to define the appropriate sample size in a definitive RCT. CONCLUSION: Beneath the complexity in retaining patients along their trajectory in pancreatic surgery department, when they had the opportunity to follow a brief psychological intervention, most of them adhered, showing a significant reduction in preoperative emotional distress and less emotional pain perception after surgery. Even if results need caution because of the high attrition rate, we can infer that our psychological intervention has the potential to be proposed in surgical setting, being short, easy to learn and applicable to a wide range of patients. CLINICAL TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov (identifier: NCT03408002). The full protocol is available from the last author. Frontiers Media S.A. 2020-03-05 /pmc/articles/PMC7066303/ /pubmed/32194490 http://dx.doi.org/10.3389/fpsyg.2020.00362 Text en Copyright © 2020 Marinelli, Danzi, Mazzi, Secchettin, Tuveri, Bonamini, Rimondini, Salvia, Bassi and Del Piccolo. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Psychology Marinelli, Veronica Danzi, Olivia Purnima Mazzi, Maria Angela Secchettin, Erica Tuveri, Massimiliano Bonamini, Deborah Rimondini, Michela Salvia, Roberto Bassi, Claudio Del Piccolo, Lidia PREPARE: PreoPerative Anxiety REduction. One-Year Feasibility RCT on a Brief Psychological Intervention for Pancreatic Cancer Patients Prior to Major Surgery |
title | PREPARE: PreoPerative Anxiety REduction. One-Year Feasibility RCT on a Brief Psychological Intervention for Pancreatic Cancer Patients Prior to Major Surgery |
title_full | PREPARE: PreoPerative Anxiety REduction. One-Year Feasibility RCT on a Brief Psychological Intervention for Pancreatic Cancer Patients Prior to Major Surgery |
title_fullStr | PREPARE: PreoPerative Anxiety REduction. One-Year Feasibility RCT on a Brief Psychological Intervention for Pancreatic Cancer Patients Prior to Major Surgery |
title_full_unstemmed | PREPARE: PreoPerative Anxiety REduction. One-Year Feasibility RCT on a Brief Psychological Intervention for Pancreatic Cancer Patients Prior to Major Surgery |
title_short | PREPARE: PreoPerative Anxiety REduction. One-Year Feasibility RCT on a Brief Psychological Intervention for Pancreatic Cancer Patients Prior to Major Surgery |
title_sort | prepare: preoperative anxiety reduction. one-year feasibility rct on a brief psychological intervention for pancreatic cancer patients prior to major surgery |
topic | Psychology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7066303/ https://www.ncbi.nlm.nih.gov/pubmed/32194490 http://dx.doi.org/10.3389/fpsyg.2020.00362 |
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