Image

ADIE-BC - Aligning Dimensions of Interoceptive Experience in Breast Cancer Survivors

ADIE-BC - Aligning Dimensions of Interoceptive Experience in Breast Cancer Survivors

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

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

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

Study details
    Cancer
    Primary Breast Cancer

NCT06954532

King's College London

21 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.