Prevalence of adjustment disorder among cancer patients, and the reach, effectiveness, cost-utility and budget impact of tailored psychological treatment: study protocol of a randomized controlled trial.
Adjustment disorder
Cancer patients
Psychological distress
Psychological intervention
Randomized controlled trial
Journal
BMC psychology
ISSN: 2050-7283
Titre abrégé: BMC Psychol
Pays: England
ID NLM: 101627676
Informations de publication
Date de publication:
23 Dec 2019
23 Dec 2019
Historique:
received:
12
09
2019
accepted:
15
12
2019
entrez:
25
12
2019
pubmed:
25
12
2019
medline:
19
3
2020
Statut:
epublish
Résumé
Information on the prevalence of adjustment disorders among cancer patients and the value of psychological interventions in this group of patients is limited. This study investigates the prevalence of adjustment disorders among cancer patients as well as the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention. This study consists of two parts. Part 1 is an observational study among a representative group of mixed cancer patients after cancer treatment on the prevalence of adjustment disorder as well as the uptake (i.e. reach) of psychological treatment. In Part 2, patients diagnosed with an adjustment disorder are invited to participate in a randomized controlled trial. Patients will be randomized to the intervention (access to the tailored psychological intervention) or control group (waitlist period of 6 months). The psychological intervention consists of three modules: one module containing psycho-education (3 sessions, all patients) and two additional modules (maximum of 6 sessions per module) provided as continuum, in case needed. Module 2 and 3 can consist of several evidence-based interventions (e.g. group interventions, mindfulness, eHealth) The primary outcome is psychological distress (HADS). Secondary outcomes are mental adjustment to cancer (MAC) and health-related quality of life (EORTC QLQ-C30). To assess the cost-utility and budget impact, quality of life (EQ-5D-5 L) and costs (iMCQ and iPCQ) will be measured. Measures will be completed at baseline and 3 and 6-months after randomization. This study will provide data of the prevalence of adjustment disorders and the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention. Netherlands Trial Register identifier: NL7763. Registered on 3 June 2019.
Sections du résumé
BACKGROUND
BACKGROUND
Information on the prevalence of adjustment disorders among cancer patients and the value of psychological interventions in this group of patients is limited. This study investigates the prevalence of adjustment disorders among cancer patients as well as the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention.
METHOD
METHODS
This study consists of two parts. Part 1 is an observational study among a representative group of mixed cancer patients after cancer treatment on the prevalence of adjustment disorder as well as the uptake (i.e. reach) of psychological treatment. In Part 2, patients diagnosed with an adjustment disorder are invited to participate in a randomized controlled trial. Patients will be randomized to the intervention (access to the tailored psychological intervention) or control group (waitlist period of 6 months). The psychological intervention consists of three modules: one module containing psycho-education (3 sessions, all patients) and two additional modules (maximum of 6 sessions per module) provided as continuum, in case needed. Module 2 and 3 can consist of several evidence-based interventions (e.g. group interventions, mindfulness, eHealth) The primary outcome is psychological distress (HADS). Secondary outcomes are mental adjustment to cancer (MAC) and health-related quality of life (EORTC QLQ-C30). To assess the cost-utility and budget impact, quality of life (EQ-5D-5 L) and costs (iMCQ and iPCQ) will be measured. Measures will be completed at baseline and 3 and 6-months after randomization.
DISCUSSION
CONCLUSIONS
This study will provide data of the prevalence of adjustment disorders and the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention.
TRIAL REGISTRATION
BACKGROUND
Netherlands Trial Register identifier: NL7763. Registered on 3 June 2019.
Identifiants
pubmed: 31870421
doi: 10.1186/s40359-019-0368-y
pii: 10.1186/s40359-019-0368-y
pmc: PMC6929410
doi:
Types de publication
Journal Article
Observational Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
89Subventions
Organisme : ZonMw
ID : 856001005
Références
J Clin Oncol. 2015 Sep 1;33(25):2763-71
pubmed: 26169621
J Clin Oncol. 2013 Feb 20;31(6):782-93
pubmed: 23319686
Jpn J Clin Oncol. 1998 May;28(5):333-8
pubmed: 9703862
Eur J Cancer Care (Engl). 2003 Mar;12(1):58-64
pubmed: 12641557
Psychooncology. 2017 Dec;26(12):2118-2126
pubmed: 28337821
BMC Cancer. 2019 May 16;19(1):462
pubmed: 31096934
Cancer. 2008 Jun 1;112(11 Suppl):2577-92
pubmed: 18428205
Cancer. 2008 Aug 15;113(4):870-8
pubmed: 18618581
J Clin Oncol. 2014 Nov 1;32(31):3540-6
pubmed: 25287821
Ann Oncol. 2016 Sep;27(9):1754-60
pubmed: 27287209
Int J Psychiatry Clin Pract. 1999;3(1):43-8
pubmed: 24945066
Cancer. 2000 Jun 15;88(12):2817-23
pubmed: 10870066
Support Care Cancer. 2011 Dec;19(12):1899-908
pubmed: 21898134
Psychol Med. 1997 Mar;27(2):363-70
pubmed: 9089829
BMC Med. 2010 Mar 24;8:18
pubmed: 20334633
Support Care Cancer. 2009 Aug;17(8):1117-28
pubmed: 19319577
Psychooncology. 2008 Jul;17(7):668-75
pubmed: 17992701
J Pain Symptom Manage. 2001 Apr;21(4):273-81
pubmed: 11312041
Psychooncology. 2013 Feb;22(2):388-95
pubmed: 22135205
J Natl Cancer Inst. 1993 Mar 3;85(5):365-76
pubmed: 8433390
J Natl Cancer Inst. 2003 Aug 6;95(15):1110-7
pubmed: 12902440
Oral Oncol. 2009 Oct;45(10):e129-33
pubmed: 19362038
Psychooncology. 2010 Jul;19(7):742-9
pubmed: 19824025
J Cancer Surviv. 2017 Dec;11(6):691-703
pubmed: 28698999
Psychooncology. 2011 Jun;20(6):639-46
pubmed: 21626611
Psychooncology. 2016 Dec;25(12):1380-1392
pubmed: 26810383
Cancer. 2017 Oct 1;123(19):3825-3834
pubmed: 28621820
J Clin Oncol. 2017 Jul 1;35(19):2173-2183
pubmed: 28471726
J Clin Oncol. 2017 Jan 20;35(3):314-324
pubmed: 27918712
Psychooncology. 2012 Dec;21(12):1275-84
pubmed: 21919118
Eur J Cancer. 2002 Mar;38 Suppl 4:S125-33
pubmed: 11858978
Arch Otolaryngol Head Neck Surg. 2008 May;134(5):528-35
pubmed: 18490576
Psychooncology. 2016 Aug;25(8):882-90
pubmed: 26893285
Can Oncol Nurs J. 2008 Winter;18(1):6-24
pubmed: 18512565
J Clin Oncol. 2006 Oct 20;24(30):4882-7
pubmed: 17050873
J Pain Symptom Manage. 2005 Jan;29(1):91-9
pubmed: 15652442
Psychol Med. 2017 Aug;47(11):1990-2001
pubmed: 28374663
Cancer. 2014 Jul 15;120(14):2199-206
pubmed: 24752999
Psychol Health. 2016 Oct;31(10):1237-54
pubmed: 27351933
Value Health. 2014 Jan-Feb;17(1):5-14
pubmed: 24438712
J Psychosom Res. 2017 Jul;98:40-46
pubmed: 28554371
J Clin Oncol. 2012 Apr 10;30(11):1160-77
pubmed: 22412146
Psychooncology. 2008 Nov;17(11):1146-51
pubmed: 18626853
Psychopathology. 2009;42(3):139-47
pubmed: 19276640
CA Cancer J Clin. 2018 Nov;68(6):394-424
pubmed: 30207593
Value Health. 2008 Mar-Apr;11(2):275-84
pubmed: 18380640
Value Health. 2016 Jun;19(4):343-52
pubmed: 27325326
Cancer. 2003 May 15;97(10):2605-13
pubmed: 12733160
Int J Surg. 2014 Dec;12(12):1495-9
pubmed: 25046131
Indian J Cancer. 2016 Jan-Mar;53(1):162-5
pubmed: 27146770
Psychol Med. 1988 Feb;18(1):203-9
pubmed: 3363039
Lancet Oncol. 2011 Feb;12(2):160-74
pubmed: 21251875
Asia Pac J Oncol Nurs. 2016 Apr-Jun;3(2):125-136
pubmed: 27981151
J Psychosom Res. 2016 Aug;87:14-21
pubmed: 27411747
Lancet Oncol. 2013 Nov;14(12):1165-74
pubmed: 24131614