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A controlled pilot trial of a nurse-led intervention (Mini-AFTERc) to manage fear of cancer recurrence in patients affected by breast cancer

McHale, Calum T., Cruickshank, Susanne, Torrens, Claire, Armes, Jo, Fenlon, Deborah, Banks, Elspeth, Kelsey, Tom and Humphris, Gerald M. (2020) A controlled pilot trial of a nurse-led intervention (Mini-AFTERc) to manage fear of cancer recurrence in patients affected by breast cancer Pilot and Feasibility Studies, 6, 60.

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Abstract

Background

Fear of cancer recurrence (FCR) is common in people affected by breast cancer. FCR is associated with increased health service and medication use, anxiety, depression and reduced quality of life. Existing interventions for FCR are time and resource intensive, making implementation in a National Health Service (NHS) setting challenging. To effectively manage FCR in current clinical practice, less intensive FCR interventions are required. Mini-AFTERc is a structured 30-min counselling intervention delivered over the telephone and is designed to normalise moderate FCR levels by targeting unhelpful behaviours and misconceptions about cancer recurrence.

This multi-centre non-randomised controlled pilot trial will investigate the feasibility of delivering the Mini-AFTERc intervention, its acceptability and usefulness, in relation to specialist breast cancer nurses (SBCNs) and patients. This protocol describes the rationale, methods and analysis plan for this pilot trial of the Mini-AFTERc intervention in everyday practice.

Methods

This study will run in four breast cancer centres in NHS Scotland, two intervention and two control centres. SBCNs at intervention centres will be trained to deliver the Mini-AFTERc intervention. Female patients who have completed primary breast cancer treatment in the previous 6 months will be screened for moderate FCR (FCR4 score: 10‑14). Participants at intervention centres will receive the Mini-AFTERc intervention within 2 weeks of recruitment. SBCNs will audio record the intervention telephone discussions with participants. Fidelity of intervention implementation will be assessed from audio recordings. All participants will complete three separate follow-up questionnaires assessing changes in FCR, anxiety, depression and quality of life over 3 months. Normalisation process theory (NPT) will form the framework for semi-structured interviews with 20% of patients and all SBCNs. Interviews will explore participants’ experience of the study, acceptability and usefulness of the intervention and factors influencing implementation within clinical practice. The ADePT process will be adopted to systematically problem solve and refine the trial design.

Discussion

Findings will provide evidence for the potential effectiveness, fidelity, acceptability and practicality of the Mini-AFTERc intervention, and will inform the design and development of a large randomised controlled trial (RCT).

Item Type: Article
Divisions : Faculty of Health and Medical Sciences > School of Health Sciences
Authors :
NameEmailORCID
McHale, Calum T.
Cruickshank, Susanne
Torrens, Claire
Armes, Jojo.armes@surrey.ac.uk
Fenlon, Deborah
Banks, Elspeth
Kelsey, Tom
Humphris, Gerald M.
Date : 7 May 2020
Funders : Chief Scientist Office (CSO)
DOI : 10.1186/s40814-020-00610-4
Copyright Disclaimer : Open Access. This 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/. The Creative Commons Public Domain Dedication waiver (http://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.
Uncontrolled Keywords : Breast cancer; Psychological; Fear of cancer recurrence; Feasibility; Brief intervention
Additional Information : Trial registration. ClinicalTrials.gov: NCT0376382. Registered 4th December 2018, https://clinicaltrials.gov/ct2/show/NCT03763825
Depositing User : Clive Harris
Date Deposited : 12 Jun 2020 14:50
Last Modified : 12 Jun 2020 14:50
URI: http://epubs.surrey.ac.uk/id/eprint/857795

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