Study protocol for the evaluation of Fear-Less: a stepped-care program for fear of cancer recurrence in survivors with early-stage disease.
Cancer survivorship
Fear of cancer recurrence
Psychology
Stepped-care
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
10 Aug 2022
10 Aug 2022
Historique:
received:
15
02
2022
accepted:
15
07
2022
entrez:
10
8
2022
pubmed:
11
8
2022
medline:
11
8
2022
Statut:
epublish
Résumé
Fear of cancer recurrence (FCR) is a significant unmet need amongst cancer survivors and is consistently associated with psychological distress and impaired quality of life. Psychological interventions for FCR, such as ConquerFear, have demonstrated efficacy in reducing FCR and improving emotional wellbeing. Unfortunately, there are barriers to the uptake of evidence-based FCR treatments in clinical practice. A stepped-care FCR treatment model may overcome these barriers and has demonstrated potential in people with advanced melanoma. This study aims to evaluate the acceptability, feasibility, and impact of a stepped-care FCR treatment model (Fear-Less) in people with other cancer types, who have completed treatment with curative intent. Sixty people with early-stage cancer (defined as individuals who have received treatment with curative intent and with no metastatic disease) will be screened for FCR using the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF). Individuals reporting moderate FCR (FCRI-SF between 13 and 21) will be offered a clinician-guided self-management resource; those reporting high FCR (FCRI-SF ≥ 22) will be offered individual therapy according to the ConquerFear protocol. Participants will complete purpose-built evaluation surveys assessing their FCR screening and intervention experiences. Clinicians will also complete a survey regarding their experiences of the treatment model. Fear-Less will be evaluated in terms of (1) acceptability (i.e., patient and clinician experience), (2) feasibility (i.e., referral uptake, treatment adherence, and time taken to screen and deliver interventions), and (3) impact (i.e., pre- to post-intervention FCR changes). The Fear-Less stepped-care model is a novel framework for screening FCR and stratifying survivors to the appropriate level of treatment. Our study will provide an indication of whether Fear-Less is a feasible and acceptable FCR model of care amongst survivors with early-stage disease and inform further investigations of this model. Australian New Zealand Clinical Trials Registry (ANZCTR); ACTRN12622000818730 .
Sections du résumé
BACKGROUND
BACKGROUND
Fear of cancer recurrence (FCR) is a significant unmet need amongst cancer survivors and is consistently associated with psychological distress and impaired quality of life. Psychological interventions for FCR, such as ConquerFear, have demonstrated efficacy in reducing FCR and improving emotional wellbeing. Unfortunately, there are barriers to the uptake of evidence-based FCR treatments in clinical practice. A stepped-care FCR treatment model may overcome these barriers and has demonstrated potential in people with advanced melanoma. This study aims to evaluate the acceptability, feasibility, and impact of a stepped-care FCR treatment model (Fear-Less) in people with other cancer types, who have completed treatment with curative intent.
METHODS
METHODS
Sixty people with early-stage cancer (defined as individuals who have received treatment with curative intent and with no metastatic disease) will be screened for FCR using the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF). Individuals reporting moderate FCR (FCRI-SF between 13 and 21) will be offered a clinician-guided self-management resource; those reporting high FCR (FCRI-SF ≥ 22) will be offered individual therapy according to the ConquerFear protocol. Participants will complete purpose-built evaluation surveys assessing their FCR screening and intervention experiences. Clinicians will also complete a survey regarding their experiences of the treatment model. Fear-Less will be evaluated in terms of (1) acceptability (i.e., patient and clinician experience), (2) feasibility (i.e., referral uptake, treatment adherence, and time taken to screen and deliver interventions), and (3) impact (i.e., pre- to post-intervention FCR changes).
DISCUSSION
CONCLUSIONS
The Fear-Less stepped-care model is a novel framework for screening FCR and stratifying survivors to the appropriate level of treatment. Our study will provide an indication of whether Fear-Less is a feasible and acceptable FCR model of care amongst survivors with early-stage disease and inform further investigations of this model.
TRIAL REGISTRATION
BACKGROUND
Australian New Zealand Clinical Trials Registry (ANZCTR); ACTRN12622000818730 .
Identifiants
pubmed: 35948952
doi: 10.1186/s40814-022-01123-y
pii: 10.1186/s40814-022-01123-y
pmc: PMC9364569
doi:
Types de publication
Journal Article
Langues
eng
Pagination
177Informations de copyright
© 2022. The Author(s).
Références
Psychooncology. 2022 Jan;31(1):30-38
pubmed: 34289212
Cancer. 2020 Jan 1;126(1):165-173
pubmed: 31550051
Psychooncology. 2021 Jan;30(1):134-137
pubmed: 32976657
Asia Pac J Clin Oncol. 2019 Oct;15(5):e68-e78
pubmed: 31215167
Psychooncology. 2020 Apr;29(4):788-795
pubmed: 32026563
Support Care Cancer. 2019 Dec;27(12):4543-4553
pubmed: 30915569
Psychooncology. 2020 Feb;29(2):430-436
pubmed: 31713279
Cancer Manag Res. 2021 Dec 01;13:8953-8965
pubmed: 34880676
Adm Policy Ment Health. 2011 Mar;38(2):65-76
pubmed: 20957426
J Clin Oncol. 2016 Dec 20;34(36):4405-4414
pubmed: 27998215
J Biomed Inform. 2009 Apr;42(2):377-81
pubmed: 18929686
Psychooncology. 2019 May;28(5):989-996
pubmed: 30825239
Cancer. 2017 Apr 15;123(8):1424-1433
pubmed: 28055119
J Clin Oncol. 2019 Nov 1;37(31):2899-2915
pubmed: 31532725
Clin Oncol (R Coll Radiol). 1997;9(1):25-9
pubmed: 9039810
Psychooncology. 2019 May;28(5):1071-1079
pubmed: 30860653
J Clin Oncol. 2017 Jul 1;35(19):2173-2183
pubmed: 28471726
J Clin Oncol. 2017 Jan 20;35(3):314-324
pubmed: 27918712
J Clin Med. 2020 Sep 14;9(9):
pubmed: 32937942
J Cancer Surviv. 2015 Sep;9(3):481-91
pubmed: 25603948
J Cancer Surviv. 2019 Oct;13(5):695-702
pubmed: 31347010
Int J Radiat Oncol Biol Phys. 2021 Nov 15;111(4):890-899
pubmed: 34265396
BMC Med Res Methodol. 2013 Aug 20;13:104
pubmed: 23961782
Psychol Res Behav Manag. 2020 Dec 21;13:1257-1268
pubmed: 33376421
Support Care Cancer. 2010 Apr;18(4):471-9
pubmed: 19865833
Psychooncology. 2017 Oct;26(10):1675-1683
pubmed: 28665542
J Clin Epidemiol. 2007 Jan;60(1):34-42
pubmed: 17161752
Br J Psychiatry. 2005 Jan;186:11-7
pubmed: 15630118
Support Care Cancer. 2016 Aug;24(8):3265-8
pubmed: 27169703
Front Public Health. 2018 Jun 11;6:149
pubmed: 29942800
J Biomed Inform. 2019 Jul;95:103208
pubmed: 31078660
Psychooncology. 2019 Mar;28(3):533-539
pubmed: 30597658
Psychooncology. 2021 Aug;30(8):1185-1195
pubmed: 33880822
Arch Dermatol. 2009 Dec;145(12):1415-27
pubmed: 20026852
Health Psychol. 2016 Dec;35(12):1320-1328
pubmed: 27513475
BMC Cancer. 2016 Apr 25;16:291
pubmed: 27112319
Pilot Feasibility Stud. 2021 Feb 3;7(1):40
pubmed: 33536076
Support Care Cancer. 2008 Feb;16(2):161-9
pubmed: 17638026
J Cancer Surviv. 2016 Aug;10(4):663-73
pubmed: 26782171
J Clin Oncol. 2017 Dec 20;35(36):4066-4077
pubmed: 29095681
Support Care Cancer. 2009 Mar;17(3):241-51
pubmed: 18414902
Psychooncology. 2018 Feb;27(2):492-499
pubmed: 28755462