Anxiety management in survivors of primary breast cancer. Mental and Behavioural Disorders
Conditions
Interventions
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 str
Sponsors
King's College London
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anxiety measured using the State-Trait Anxiety Inventory: Trait subscale at 8 weeks post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Anxiety severity measured using State-Trait Anxiety Inventory – Trait Version (STAI-T) at 18 weeks post-randomisation;Generalised anxiety symptoms measured using Generalised Anxiety Disorder-7 (GAD-7) at 8 weeks, 18 weeks post-randomisation;Fear of cancer recurrence measured using Fear of Cancer Recurrence Inventory – Short Form (FCRI-SF) at 8 weeks, 18 weeks post-randomisation;Anxiety sensitivity measured using Anxiety Sensitivity Index (ASI) at 8 weeks, 18 weeks post-randomisation;Depressive symptoms measured using Patient Health Questionnaire-8 (PHQ-8) at 8 weeks, 18 weeks post-randomisation;Health-related quality of life measured using EQ-5D-5L at 8 weeks, 18 weeks post-randomisation;Fatigue measured using PROMIS Fatigue Short Form 7a at 8 weeks, 18 weeks post-randomisation;Pain intensity measured using PROMIS Pain Intensity 1a at 8 weeks, 18 weeks post-randomisation;Pain interference measured using PROMIS Pain Interference 6a at 8 weeks, 18 weeks post-randomisation;Menopause-related vasomotor symptom interference (hot flushes/night sweats) measured using MENQOL Vasomotor Domain at 8 weeks, 18 weeks post-randomisation;Work ability and employment status measured using Work Ability Score (WAS-1) plus study-specific work status items at 8 weeks, 18 weeks post-randomisation;Patient global impression of change measured using Patient Global Impression of Change (PGIC) at 8 weeks, 18 weeks post-randomisation;[Mechanistic secondary outcome] Interoceptive accuracy measured using Heartbeat Discrimination Task (HDT) and Heartbeat Tracking Task (HTT) at Midpoint, 8 weeks post-randomisation;[Mechanistic secondary outcome] Interoceptive sensibility measured using Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2), Bodily Threat Monitoring Scale (BTMS), and Body Mindset Inventory-2 (BMI-2) at MAIA-2: Midpoint, 8 weeks, 18 weeks; BTMS: 8 weeks, 18 weeks; BMI-2: Midpoint, 8 weeks, 18 weeks;[Mechanistic secondary outcome] Diurnal cortisol measured using Salivary co | — |
Countries
England, United Kingdom
Contacts
Public ContactLauren Heathcote
Outcome results
None listed