Clinical trial NCT06954532: ADIE-BC - Aligning Dimensions of Interoceptive Experience in Breast Cancer Survivors
Official title: ADIE-BC - Aligning Dimensions of Interoceptive Experience in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Primary Breast Cancer
Keywords: Breast Cancer
Primary Breast Cancer
ADIE Therapy
Biobehavioral Medicine
Anxiety Management
Interoception
Emotion Regulation
Interoceptive Training
Cardiac Interoception
Mind-Body Therapy
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University College, London
name: Brighton & Sussex Medical School
First posted: 2025-05-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open-label, single arm pilot study, in which all participants will receive ADIE Therapy.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Acceptability of the Intervention - Theoretical Framework of Acceptability (TFA) Questionnaire
timeFrame: Post-Treatment (Week 7)
measure: Feasibility and Acceptability of the Intervention - Qualitative Interview
timeFrame: Post-Treatment (Week 7)
measure: Acceptability of the Intervention - Net Promoter Score
timeFrame: Post-Treatment (Week 7)
measure: Feasibility of the Study - Participant Retention
timeFrame: Baseline through Post-Treatment (Week 7)
measure: Feasibility of the Study - Session Adherence
timeFrame: Baseline through Post-Treatment (Week 7)
Secondary outcomes:
measure: Cardiac Interoceptive Accuracy, Awareness, and Sensibility Scores
timeFrame: Baseline, Midpoint (Week 4), and Post-Treatment (Week 7)
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Baseline, Midpoint (Week 4), and Post-Treatment (Week 7)
measure: Spielberger State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline, Midpoint (Week 4), and Post-Treatment (Week 7)
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: Baseline, Midpoint (Week 4), and Post-Treatment (Week 7)
measure: Anxiety Sensitivity Index (ASI)
timeFrame: Baseline, Midpoint (Week 4), and Post-Treatment (Week 7)
measure: Toronto Alexithymia Scale (TAS-20)
timeFrame: Baseline, Midpoint (Week 4), and Post-Treatment (Week 7)
measure: Fear of Cancer Recurrence Inventory - Short Form (FCRI-SF)
timeFrame: Baseline, Midpoint (Week 4), and Post-Treatment (Week 7)
measure: Body Perceptions Questionnaire (BPQ) - Body Awareness Short Form
timeFrame: Baseline, Midpoint (Week 4), and Post-Treatment (Week 7)
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
timeFrame: Baseline, Midpoint (Week 4), and Post-Treatment (Week 7)
measure: Bodily Threat Monitoring Scale (BTMS)
timeFrame: Baseline, Midpoint (Week 4), and Post-Treatment (Week 7)
measure: Body Mindset Inventory - Version 2 (BMI-2)
timeFrame: Baseline, Midpoint (Week 4), and Post-Treatment (Week 7)
measure: EuroQoL 5 Dimensions, 5 Levels (EQ-5D-5L)
timeFrame: Baseline, Midpoint (Week 4), and Post-Treatment (Week 7)
measure: Pain Intensity, Interference, and Body Location
timeFrame: Baseline, Midpoint (Week 4), and Post-Treatment (Week 7)
measure: Patient Global Impression of Change (PGIC) Scale
timeFrame: Post-Treatment (Week 7)
Other outcomes:
measure: Salivary and Blood-Based Biomarkers
timeFrame: Assessed at Baseline and Post-Treatment (Week 7)
measure: Adverse Events Monitoring
timeFrame: Structured questions Post-Treatment (Week 7); Open-text form available continuously throughout participation.
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Lauren C. Heathcote, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quadt L, Garfinkel SN, Mulcahy JS, Larsson DE, Silva M, Jones AM, Strauss C, Critchley HD. Interoceptive training to target anxiety in autistic adults (ADIE): A single-center, superiority randomized controlled trial. EClinicalMedicine. 2021 Aug 1;39:101042. doi: 10.1016/j.eclinm.2021.101042. eCollection 2021 Sep.