Cargando…

Study protocol for the evaluation of Fear-Less: a stepped-care program for fear of cancer recurrence in survivors with early-stage disease

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Tran, Mei Jun, Jefford, Michael, Smith, Ben, Lynch, Fiona, Dhillon, Haryana M., Shaw, Joanne, McDowell, Lachlan, White, Alan, Halloran, Clare, Wiesenfeld, David, Ftanou, Maria
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9364569/
https://www.ncbi.nlm.nih.gov/pubmed/35948952
http://dx.doi.org/10.1186/s40814-022-01123-y
_version_ 1784765172029587456
author Tran, Mei Jun
Jefford, Michael
Smith, Ben
Lynch, Fiona
Dhillon, Haryana M.
Shaw, Joanne
McDowell, Lachlan
White, Alan
Halloran, Clare
Wiesenfeld, David
Ftanou, Maria
author_facet Tran, Mei Jun
Jefford, Michael
Smith, Ben
Lynch, Fiona
Dhillon, Haryana M.
Shaw, Joanne
McDowell, Lachlan
White, Alan
Halloran, Clare
Wiesenfeld, David
Ftanou, Maria
author_sort Tran, Mei Jun
collection PubMed
description 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: 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: 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: Australian New Zealand Clinical Trials Registry (ANZCTR); ACTRN12622000818730. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-022-01123-y.
format Online
Article
Text
id pubmed-9364569
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-93645692022-08-11 Study protocol for the evaluation of Fear-Less: a stepped-care program for fear of cancer recurrence in survivors with early-stage disease Tran, Mei Jun Jefford, Michael Smith, Ben Lynch, Fiona Dhillon, Haryana M. Shaw, Joanne McDowell, Lachlan White, Alan Halloran, Clare Wiesenfeld, David Ftanou, Maria Pilot Feasibility Stud Study Protocol 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: 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: 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: Australian New Zealand Clinical Trials Registry (ANZCTR); ACTRN12622000818730. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-022-01123-y. BioMed Central 2022-08-10 /pmc/articles/PMC9364569/ /pubmed/35948952 http://dx.doi.org/10.1186/s40814-022-01123-y Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Tran, Mei Jun
Jefford, Michael
Smith, Ben
Lynch, Fiona
Dhillon, Haryana M.
Shaw, Joanne
McDowell, Lachlan
White, Alan
Halloran, Clare
Wiesenfeld, David
Ftanou, Maria
Study protocol for the evaluation of Fear-Less: a stepped-care program for fear of cancer recurrence in survivors with early-stage disease
title Study protocol for the evaluation of Fear-Less: a stepped-care program for fear of cancer recurrence in survivors with early-stage disease
title_full Study protocol for the evaluation of Fear-Less: a stepped-care program for fear of cancer recurrence in survivors with early-stage disease
title_fullStr Study protocol for the evaluation of Fear-Less: a stepped-care program for fear of cancer recurrence in survivors with early-stage disease
title_full_unstemmed Study protocol for the evaluation of Fear-Less: a stepped-care program for fear of cancer recurrence in survivors with early-stage disease
title_short Study protocol for the evaluation of Fear-Less: a stepped-care program for fear of cancer recurrence in survivors with early-stage disease
title_sort study protocol for the evaluation of fear-less: a stepped-care program for fear of cancer recurrence in survivors with early-stage disease
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9364569/
https://www.ncbi.nlm.nih.gov/pubmed/35948952
http://dx.doi.org/10.1186/s40814-022-01123-y
work_keys_str_mv AT tranmeijun studyprotocolfortheevaluationoffearlessasteppedcareprogramforfearofcancerrecurrenceinsurvivorswithearlystagedisease
AT jeffordmichael studyprotocolfortheevaluationoffearlessasteppedcareprogramforfearofcancerrecurrenceinsurvivorswithearlystagedisease
AT smithben studyprotocolfortheevaluationoffearlessasteppedcareprogramforfearofcancerrecurrenceinsurvivorswithearlystagedisease
AT lynchfiona studyprotocolfortheevaluationoffearlessasteppedcareprogramforfearofcancerrecurrenceinsurvivorswithearlystagedisease
AT dhillonharyanam studyprotocolfortheevaluationoffearlessasteppedcareprogramforfearofcancerrecurrenceinsurvivorswithearlystagedisease
AT shawjoanne studyprotocolfortheevaluationoffearlessasteppedcareprogramforfearofcancerrecurrenceinsurvivorswithearlystagedisease
AT mcdowelllachlan studyprotocolfortheevaluationoffearlessasteppedcareprogramforfearofcancerrecurrenceinsurvivorswithearlystagedisease
AT whitealan studyprotocolfortheevaluationoffearlessasteppedcareprogramforfearofcancerrecurrenceinsurvivorswithearlystagedisease
AT halloranclare studyprotocolfortheevaluationoffearlessasteppedcareprogramforfearofcancerrecurrenceinsurvivorswithearlystagedisease
AT wiesenfelddavid studyprotocolfortheevaluationoffearlessasteppedcareprogramforfearofcancerrecurrenceinsurvivorswithearlystagedisease
AT ftanoumaria studyprotocolfortheevaluationoffearlessasteppedcareprogramforfearofcancerrecurrenceinsurvivorswithearlystagedisease