Aligning Dimensions of Interoceptive Experience after Breast Cancer (the ADIE-BC trial)
Anxiety management in survivors of primary breast cancer.
Participants will complete baseline assessments before being randomly allocated in a 1:1 ratio to either ADIE-BC or Enhanced Usual Care (EUC). Randomisation will use a secure web-based system with stratified block randomisation and varying block sizes. Stratification factors are recruitment source, time since completion of cancer treatment, and baseline anxiety severity. Participants allocated to ADIE-BC will receive six individual face-to-face sessions of interoceptive training delivered over approximately six weeks. Sessions involve biofeedback-assisted heartbeat discrimination and heartbeat tracking exercises using real-time heart rate monitoring, together with confidence ratings, structured feedback, and supportive psychoeducational materials designed to encourage adaptive engagement with bodily sensations, emotion regulation and helpful body mindsets. Participants also receive an ADIE-BC handbook and reminder card to support application of the techniques in everyday life. Participants allocated to Enhanced Usual Care will receive a psychoeducational handbook providing evidence-based information and strategies for managing anxiety following breast cancer, together with a reminder card and signposting to additional support resources. They will also receive brief clinical check-ins alongside study visits to discuss use of the handbook and anxiety management strategies.
1. Aged 18 years or older 2. Resident in the United Kingdom 3. Able and willing to attend weekly sessions in London for 8 consecutive weeks 4. Able to read, write, and follow instructions in English 5. Have previously received a diagnosis of primary breast cancer (stages 0-III) 6. Have completed hospital-based cancer treatment between 6 months and 10 years prior to enrolment (long-term adjuvant therapies are permitted) 7. Meet criteria for at least mild anxiety, defined using a pre-determined cut-off score GAD-2 (≥2) (GAD-2: Kroenke et al., 2007)
Key exclusion criteria: Unable to provide informed consent Cancer-related exclusions: 1. Diagnosis of Lobular Carcinoma in Situ (LCIS) only 2. Diagnosis of secondary or metastatic breast cancer Other ADIE therapy contraindications: 1. Previous participation in any ADIE therapy trial 2. Presence of an implantable cardioverter defibrillator and/or pacemaker 3. Scheduled to begin Cognitive Behavioural Therapy (CBT) during the intervention period 4. Health anxiety specifically related to cardiac symptoms or cardiac events where it is considered to interfere with ADIE therapy 5. History of severe cardiac events (e.g., myocardial infarction, sudden cardiac arrest, stroke) within the past 12 months where it is considered to interfere with ADIE therapy Other physical health exclusions: 1. Pregnancy 2. Current substance or alcohol dependence where it is considered to interfere with ADIE therapy 3. Neurological diagnoses, including epilepsy, dementia, or Parkinson’s disease where it is considered to interfere with ADIE therapy Other mental health exclusions: 1. Current medium or high risk of suicide intention and plan, determined by item 9 of the Patient Health Questionnaire (PHQ-9) and accompanying risk assessment questions 2. Current severe depression determined by Patient Health Questionnaire (PHQ-8) (≥20) 3. Current diagnosis of obsessive-compulsive disorder (OCD), psychosis, or bipolar disorder where is considered to interfere with ADIE therapy