Effectiveness of a brief manualized intervention, Managing Cancer and Living Meaningfully (CALM), adapted to the Italian cancer care setting: Study protocol for a single-blinded randomized controlled trial.
Attachment security
CALM
Clinical trial
Death anxiety
End-of-life-intervention
Existential
Palliative care
Psychotherapy
Randomized controlled trial
Journal
Contemporary clinical trials communications
ISSN: 2451-8654
Titre abrégé: Contemp Clin Trials Commun
Pays: Netherlands
ID NLM: 101671157
Informations de publication
Date de publication:
Dec 2020
Dec 2020
Historique:
received:
07
04
2020
revised:
29
08
2020
accepted:
03
10
2020
entrez:
22
10
2020
pubmed:
23
10
2020
medline:
23
10
2020
Statut:
epublish
Résumé
Patients with advanced cancer suffer from psychosocial distress that may impair quality of life and that may be ameliorated by psychotherapeutic treatment. We describe here the methodology of a randomized controlled trial (RCT) to assess the effectiveness of a novel, brief, semi-structured psychotherapeutic intervention to reduce distress and increase well-being in patients with advanced or metastatic cancer. The intervention, called Managing Cancer and Living Meaningfully (CALM), was originally developed in Canada and we are now testing its Italian adaptation (CALM-IT). The study is a single-blinded phase III RCT with assessment at baseline, 3 and 6 months with two conditions: CALM-IT versus a nonspecific supportive intervention (SPI). Eligibility criteria include: ≥ 18 years of age; fluency in the Italian language; no cognitive deficit, and diagnosis of advanced or metastatic cancer with an expected survival of 12-18 months. CALM-IT includes up to 12 sessions, delivered over 6 months and covers 4 domains: i) Symptom Management and Communication with Health Care Providers; ii) Changes in Self and Relations with Close Others; iii) Sense of Meaning and Purpose; and iv) the Future and Mortality. The primary outcome is difference in severity of depressive symptoms between treatment arm and the primary endpoint is 6 months. The secondary endpoint is 3 months and secondary outcomes are: generalized anxiety, distress about dying and death, demoralization, spiritual well-being, attachment security, posttraumatic growth, communication with partners, quality of life, and satisfaction with clinical care. If shown to be effective, CALM-IT can be implemented nationally to relieve distress and to promote psychological well-being in patients with advanced cancer.
Identifiants
pubmed: 33089003
doi: 10.1016/j.conctc.2020.100661
pii: S2451-8654(20)30145-9
pmc: PMC7566943
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100661Informations de copyright
© 2020 The Authors. Published by Elsevier Inc.
Déclaration de conflit d'intérêts
The authors declare that they have no competing interests.
Références
Postgrad Med J. 2016 Jun;92(1088):341-5
pubmed: 26933233
Psychother Psychosom. 1974;24(4-6):303-10
pubmed: 4449943
Psychooncology. 2018 Nov;27(11):2623-2630
pubmed: 29761579
J Gen Intern Med. 2007 Nov;22(11):1596-602
pubmed: 17874169
BMJ Support Palliat Care. 2019 Jun;9(2):209-218
pubmed: 26787360
Palliat Med. 2009 Dec;23(8):739-53
pubmed: 19825894
Psychooncology. 2005 Aug;14(8):661-70
pubmed: 15651069
Acta Oncol. 2017 Feb;56(2):146-155
pubmed: 28140731
Psychother Psychosom. 2020;89(6):402-404
pubmed: 32191940
Psychol Med. 2000 Jul;30(4):831-40
pubmed: 11037091
Psychosomatics. 2015 Nov-Dec;56(6):634-43
pubmed: 26411374
Palliat Support Care. 2019 Oct;17(5):596-603
pubmed: 31196235
Int Rev Psychiatry. 2017 Oct;29(5):389-402
pubmed: 28753076
J Am Acad Psychoanal Dyn Psychiatry. 2008 Spring;36(1):181-96
pubmed: 18399753
J Pediatr Hematol Oncol. 2011 Oct;33 Suppl 2:S140-5
pubmed: 21952572
Arch Intern Med. 2006 May 22;166(10):1092-7
pubmed: 16717171
Psychooncology. 2009 May;18(5):490-9
pubmed: 18821528
Psychol Med. 2014 Apr;44(5):897-907
pubmed: 23778105
J Trauma Stress. 1996 Jul;9(3):455-71
pubmed: 8827649
Psychooncology. 2017 Nov;26(11):1965-1971
pubmed: 28263003
Ann Behav Med. 2002 Winter;24(1):49-58
pubmed: 12008794
Palliat Support Care. 2010 Dec;8(4):405-13
pubmed: 20875203
Curr Psychiatry Rep. 2017 Jun;19(6):33
pubmed: 28488207
Psychooncology. 2018 Oct;27(10):2310-2316
pubmed: 29980165
Psychooncology. 2019 Jul;28(7):1394-1407
pubmed: 31077475
JAMA. 1999 Nov 10;282(18):1737-44
pubmed: 10568646
Palliat Med. 2018 Jan;32(1):172-184
pubmed: 28786328
J Pain. 2012 Dec;13(12):1258-68
pubmed: 23182231
Death Stud. 2007 Jul;31(6):549-61
pubmed: 17726829
Eur J Cancer. 1994;30A(9):1326-36
pubmed: 7999421
J Affect Disord. 2009 Feb;113(1-2):127-32
pubmed: 18558439
Eur J Cancer Care (Engl). 2016 Jul;25(4):608-15
pubmed: 27271213
Eur J Cancer Care (Engl). 2008 Mar;17(2):145-51
pubmed: 18302651
Cancer. 2000 Sep 1;89(5):1162-71
pubmed: 10964347
Res Psychother. 2018 Oct 31;21(3):319
pubmed: 32913769
Adv Psychosom Med. 2013;33:75-87
pubmed: 23816865
J Clin Oncol. 2018 Aug 10;36(23):2422-2432
pubmed: 29958037
Psychol Psychother. 2019 Jun;92(2):261-276
pubmed: 31001925
Hematol Oncol Clin North Am. 2002 Jun;16(3):671-700
pubmed: 12170575
BMC Palliat Care. 2020 Mar 6;19(1):26
pubmed: 32143609
Cancer Treat Rev. 2017 May;56:16-27
pubmed: 28453966
BMJ Support Palliat Care. 2017 Dec;7(4):427-434
pubmed: 28768678
J Palliat Care. 2004 Winter;20(4):269-76
pubmed: 15690829
Int Rev Psychiatry. 2017 Oct;29(5):377-388
pubmed: 28783462
Br J Clin Psychol. 2019 Nov;58(4):452-467
pubmed: 31318066
Eur J Cancer. 2011 Mar;47(4):554-60
pubmed: 21126869
Cancer. 2016 Jul 15;122(14):2130-3
pubmed: 27171755
Support Care Cancer. 2019 Nov;27(11):4353-4358
pubmed: 30900054
Trials. 2015 Sep 03;16:391
pubmed: 26335704
J Stat Softw. 2013 Sep;54(10):
pubmed: 24403868
Clin Psychol Psychother. 2012 Jan-Feb;19(1):91-5
pubmed: 22232048
J Clin Oncol. 2005 Aug 20;23(24):5520-5
pubmed: 16110012
Palliat Med. 2014 Mar;28(3):234-42
pubmed: 24170718
Palliat Med. 2012 Jul;26(5):713-21
pubmed: 22042225
Palliat Med. 2016 Sep;30(8):772-9
pubmed: 26857360
J Pain Symptom Manage. 2018 Mar;55(3):985-991.e1
pubmed: 29155291
Int J Methods Psychiatr Res. 2006;15(1):1-11
pubmed: 16676681
J Psychosom Res. 2020 Jan;128:109889
pubmed: 31812103
J Pediatr Hematol Oncol. 2011 Oct;33 Suppl 2:S96-101
pubmed: 21952581
J Pain Symptom Manage. 2003 May;25(5):449-58
pubmed: 12727043
J Affect Disord. 2004 Dec;83(2-3):243-8
pubmed: 15555721
Clin Psychol Rev. 2008 Mar;28(3):472-93
pubmed: 17804130
BMC Cancer. 2015 Aug 19;15:592
pubmed: 26286128
Psychooncology. 2018 Nov;27(11):2616-2622
pubmed: 29943491