ADIE-BC - Aligning Dimensions of Interoceptive Experience in Breast Cancer Survivors
- Conditions
- CancerPrimary Breast Cancer
- Registration Number
- NCT06954532
- Lead Sponsor
- King's College London
- Brief Summary
A breast cancer diagnosis can lead to significant anxiety, and for many survivors, this anxiety continues well beyond the end of treatment. While standard anxiety therapies are helpful for some, these therapies often fall short for breast cancer survivors due to an individual's unique experience-particularly changes in how survivors perceive and relate to the body, a process known as interoception.
The study will evaluate the feasibility and acceptability of a novel interoceptive training approach called ADIE Therapy. ADIE Therapy trains participants to better recognise bodily signals, and has shown promising results in reducing anxiety in non-cancer populations. The aim of the study is to assess the acceptability and feasibility of ADIE Therapy for breast cancer survivors.
- Detailed Description
Anxiety is a common and often long-lasting psychological consequence of a breast cancer diagnosis. Post-cancer anxiety frequently co-occurs with somatic symptoms such as persistent pain and fatigue. For many individuals, feelings of anxiety do not resolve with the completion of cancer treatment and can persist for months or even years. For yet others, anxiety increases after cancer treatment has ended. Although standard therapies-such as cognitive behavioural therapy or pharmacological interventions-can be effective for some, these interventions do not adequately address the needs of all breast cancer survivors. This may be due, in part, to the unique physical and emotional challenges faced by this group, including changes in the way internal bodily sensations are experienced and interpreted.
Interoception refers to the process by which the nervous system senses, interprets and integrates information from inside the body. ADIE Therapy - which stands for Aligning Dimensions of Interoceptive Experience - has shown promise as a novel interoceptive intervention to reduce anxiety and somatic symptoms in non-cancer populations. ADIE Therapy uses simple, biofeedback-based tasks to enhance precision in perceiving cardiac interoceptive signals.
The primary aim of the study is to demonstrate the acceptability and feasibility of ADIE Therapy for survivors of primary breast cancer. A mixed-methods approach will be used to evaluate the feasibility and acceptability of ADIE Therapy, incorporating both quantitative and qualitative measures. Secondary aims include ascertaining whether ADIE Therapy leads to improvements in interoceptive measurements (including self-reported interoceptive sensibility and objective interoceptive markers), anxiety symptoms (including generalised and cancer-specific anxiety), depressive symptoms, somatic symptoms, and body mindsets. Additional secondary aims include exploring the feasibility of incorporating blood and saliva collection into the ADIE-BC research protocol, which could facilitate assessment of biomarker outcomes in a future randomised controlled trial of ADIE-BC.
Participants will be recruited through charity and foundation partners, as well as through community settings. ADIE Therapy involves the administration of simple biofeedback-based tasks designed to progressively improve objective interoceptive accuracy, specifically through cardiac interoceptive exercises. A schedule of six interoceptive training sessions will be agreed with each participant, with the option to complete intermediate training sessions either in-person or at home. During each training session, participants will complete the cardiac interoceptive tasks with active feedback, before and after a 2-to-3-minute period of self-directed exercise, intended to elevate heart rate. The resulting cardiovascular arousal aims to amplify sensations associated with the heartbeat, thereby facilitating perception during interoceptive tasks. In addition to training, participants will complete three interoceptive assessments: pre-training, midpoint (Week 4), and post-training (Week 7), each scheduled within a ±2-week window. A series of questionnaires will also be administered before and after training, and an optional exit interview will be offered to gather feedback on the experience of participating in ADIE Therapy.
The present study is an open-label, single-arm acceptability and feasibility study. The investigators aim to recruit a total of 15 participants.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
- 18 years old or older
- Residing in the UK and able to travel into London
- Can read and write in English
- Have had a diagnosis of Primary Breast Cancer
- Have completed active, hospital-based treatment for primary breast cancer (Stages 1, 2 or 3; this refers to radiotherapy, surgery, or chemotherapy) 6 months - 10 years previously (this does not apply to ongoing endocrine (hormone) therapy)
- Currently taking medication for cardiac arrhythmia (e.g., beta blockers)
- Currently in active treatment for breast cancer and/or other types of cancer
- Currently pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Acceptability of the Intervention - Theoretical Framework of Acceptability (TFA) Questionnaire Post-Treatment (Week 7) Acceptability will be assessed quantitatively at the end of treatment through a brief survey related to acceptability, including ease of use, satisfaction, and overall experience. Survey responses will be reported categorically. Responses are measured using a five-point Likert scale from 'Strongly disagree' to 'Strongly agree' with higher scores indicating greater acceptability.
Feasibility and Acceptability of the Intervention - Qualitative Interview Post-Treatment (Week 7) Feasibility and acceptability will be assessed at the end of treatment through semi-structured interviews exploring participants' experiences with the intervention, including ease of use, comprehensibility, perceived usefulness, barriers to participation, and suggestions for improvement. Qualitative responses will be described and summarized.
Acceptability of the Intervention - Net Promoter Score Post-Treatment (Week 7) Acceptability will be evaluated by examining mean promoter score (measured on 10-point Likert scale) post intervention. Range 0-10 (higher scores indicate more acceptability).
Feasibility of the Study - Participant Retention Baseline through Post-Treatment (Week 7) Retention rates will be assessed by tracking the proportion of participants who complete the full ADIE Therapy programme, including all scheduled training sessions and study assessments.
Feasibility of the Study - Session Adherence Baseline through Post-Treatment (Week 7) Session adherence will be assessed by tracking attendance across the six scheduled interoceptive training sessions. Adherence will be calculated as the proportion of completed sessions per participant.
- Secondary Outcome Measures
Name Time Method Cardiac Interoceptive Accuracy, Awareness, and Sensibility Scores Baseline, Midpoint (Week 4), and Post-Treatment (Week 7) Interoceptive outcomes will be assessed using heartbeat detection tasks to evaluate three domains of cardiac interoception:
1. Accuracy (objective performance on heartbeat detection tasks)
2. Sensibility (subjective confidence or perception of performance)
3. Awareness (metacognitive insight into accuracy, i.e., the correspondence between confidence and actual performance).
These measures will be collected to assess participants' interoceptive processing during the intervention.Generalized Anxiety Disorder (GAD-7) Baseline, Midpoint (Week 4), and Post-Treatment (Week 7) The GAD-7 assesses core symptoms and signs of anxiety with 7 items. Participants respond on a four-point scale based on their experience of anxiety over the past two weeks.
Spielberger State-Trait Anxiety Inventory (STAI) Baseline, Midpoint (Week 4), and Post-Treatment (Week 7) The STAI assesses both state anxiety (temporary) and trait anxiety (general tendency) with 40 items, 20 for state anxiety and 20 for trait anxiety. Items are rated on a four-point scale.
Patient Health Questionnaire (PHQ-8) Baseline, Midpoint (Week 4), and Post-Treatment (Week 7) The PHQ-8 measures core symptoms and signs of depression. Participants respond on a four-point scale based on their experience over the last two weeks.
Anxiety Sensitivity Index (ASI) Baseline, Midpoint (Week 4), and Post-Treatment (Week 7) The ASI evaluates concerns about anxiety and its potential consequences. The ASI is comprised of 16 items rated on a four-point scale.
Toronto Alexithymia Scale (TAS-20) Baseline, Midpoint (Week 4), and Post-Treatment (Week 7) The TAS-20 assesses difficulty in identifying and describing emotions. The TAS-20 consists of 20 items rated on a four-point scale.
Fear of Cancer Recurrence Inventory - Short Form (FCRI-SF) Baseline, Midpoint (Week 4), and Post-Treatment (Week 7) The FCRI-SF assesses participants' fears of cancer recurrence and how this impacts their lives. It consists of 9 items, with a mix of five-point scales and specific frequency/perceived risk questions.
Body Perceptions Questionnaire (BPQ) - Body Awareness Short Form Baseline, Midpoint (Week 4), and Post-Treatment (Week 7) A measure of sensitivity for internal bodily functions with 26 items. Values at the high end of the scale reflect hypersensitivity and values at the low scale reflect hyposensitivity.
Multidimensional Assessment of Interoceptive Awareness (MAIA-2) Baseline, Midpoint (Week 4), and Post-Treatment (Week 7) The MAIA-2 assesses various dimensions of interoception with 37 items. It contains 8 subscales assessing 5 dimensions of body awareness.
Bodily Threat Monitoring Scale (BTMS) Baseline, Midpoint (Week 4), and Post-Treatment (Week 7) Bodily threat monitoring will be assessed via a 19-item self-report measure, rated on a five-point scale. Higher scores indicate greater propensity to monitor the body for threatening signs and symptoms.
Body Mindset Inventory - Version 2 (BMI-2) Baseline, Midpoint (Week 4), and Post-Treatment (Week 7) The BMI-2 assesses mindsets participants may hold about their body in the context of chronic disease. Participants respond by indicating how much they agree with each statement on a six-point scale.
Patient Global Impression of Change (PGIC) Scale Post-Treatment (Week 7) Single question asking participants to rate how their condition has changed since a specified point in time, with lower scores indicating greater degree of improvement.
EuroQoL 5 Dimensions, 5 Levels (EQ-5D-5L) Baseline, Midpoint (Week 4), and Post-Treatment (Week 7) The EQ-5D-5L measures five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
Pain Intensity, Interference, and Body Location Baseline, Midpoint (Week 4), and Post-Treatment (Week 7) The PROMIS interference and intensity measures, as well as items from the Graded Chronic Pain Scale-Revised (Von Korff et al., 2020) and the body map from the Brief Pain Inventory (Cleeland et al, 1994) will be used to assess pain.
Trial Locations
- Locations (1)
King's College London
🇬🇧London, United Kingdom