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

Medicine (General) RC0254 Neoplasms. Tumors. Oncology (including Cancer) 610 Feasibility 16. Peace & justice Brief intervention 3rd-NDAS 3. Good health RC0254 Study Protocol 03 medical and health sciences Breast cancer Fear of cancer recurrence R5-920 0302 clinical medicine SDG 3 - Good Health and Well-being RC0321 Psychological RC0321 Neuroscience. Biological psychiatry. Neuropsychiatry
DOI: 10.1186/s40814-020-00610-4 Publication Date: 2020-05-07T11:03:17Z
ABSTRACT
Fear of cancer recurrence (FCR) is common in people affected by breast cancer. FCR associated with increased health service and medication use, anxiety, depression reduced quality life. Existing interventions for are time resource intensive, making implementation a National Health Service (NHS) setting challenging. To effectively manage current clinical practice, less intensive required. Mini-AFTERc structured 30-min counselling intervention delivered over the telephone designed to normalise moderate levels targeting unhelpful behaviours misconceptions about recurrence.This multi-centre non-randomised controlled pilot trial will investigate feasibility delivering intervention, its acceptability usefulness, relation specialist nurses (SBCNs) patients. This protocol describes rationale, methods analysis plan this everyday practice. study run four centres NHS Scotland, two control centres. SBCNs at be trained deliver intervention. Female patients who have completed primary treatment previous 6 months screened (FCR4 score: 10‑14). Participants receive within 2 weeks recruitment. audio record discussions participants. Fidelity assessed from recordings. All participants complete three separate follow-up questionnaires assessing changes FCR, life 3 months. Normalisation process theory (NPT) form framework semi-structured interviews 20% all SBCNs. Interviews explore participants' experience study, usefulness factors influencing The ADePT adopted systematically problem solve refine design. Findings provide evidence potential effectiveness, fidelity, practicality inform design development large randomised (RCT). ClinicalTrials.gov: NCT0376382. Registered 4th December 2018, https://clinicaltrials.gov/ct2/show/NCT03763825.
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