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

NCT06954532 | Completed

• 1 other identifier: HR/DP-23/24-41430
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• Acceptability of the Intervention - Theoretical Framework of Acceptability (TFA) Questionnaire

  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.

  Post-Treatment (Week 7)

• Feasibility and Acceptability of the Intervention - Qualitative Interview

  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.

  Post-Treatment (Week 7)

• Acceptability of the Intervention - Net Promoter Score

  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).

  Post-Treatment (Week 7)

• Feasibility of the Study - Participant Retention

  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.

  Baseline through Post-Treatment (Week 7)

• Feasibility of the Study - Session Adherence

  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.

  Baseline through Post-Treatment (Week 7)

Secondary Outcomes (14)

• Cardiac Interoceptive Accuracy, Awareness, and Sensibility Scores

  Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)

• Generalized Anxiety Disorder (GAD-7)

  Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)

• Spielberger State-Trait Anxiety Inventory (STAI)

  Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)

• Patient Health Questionnaire (PHQ-8)

  Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)

• Anxiety Sensitivity Index (ASI)

  Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)

Other Outcomes (2)

• Salivary and Blood-Based Biomarkers

  Assessed at Baseline and Post-Treatment (Week 7)

• Adverse Events Monitoring

  Structured questions Post-Treatment (Week 7); Open-text form available continuously throughout participation.

Study Arms (1)

ADIE Therapy

EXPERIMENTAL

Participants will undergo 6 sessions of cardiac interoceptive training (ADIE Therapy).

Behavioral: Interoceptive training

Interventions

Interoceptive training BEHAVIORAL

There will be 6 interoceptive training sessions. Each training session will comprise two blocks, between which participants will undergo a self-paced, light physical activity that aims to enhance heartbeat perception and lasts 2 to 3 minutes. During the pre- and post-exercise block, each participant will complete cardiac interoceptive tasks, and for each trial, note their confidence in their answer on a visual analogue scale and then be given accurate feedback about their objective heartbeat perception accuracy, relative to their objective accuracy.

ADIE Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• University College, London: collaborator
• Brighton & Sussex Medical School: collaborator

Study Sites (1)

King's College London

London, SE1 9RT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34401684 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Emotional Regulation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Self-Control; Social Behavior; Behavior

Study Officials

• Lauren C. Heathcote, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open-label, single arm pilot study, in which all participants will receive ADIE Therapy.

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: May 1, 2025
• Study Start: June 13, 2025
• Primary Completion: December 18, 2025
• Study Completion: April 20, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: De-identified IPD will be shared on an online, open science data repository platform from the time that the study has been published and will be available indefinitely.
• Access Criteria: De-identified IPD will be available open access.

Locations

GB (1)