CancerADIE-BCNCT06954532
ADIE-BC - Aligning Dimensions of Interoceptive Experience in Breast Cancer Survivors
A study testing Interoceptive training in people with Cancer and Primary Breast Cancer, run by King's College London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Primary Breast Cancer
- What is being tested?
- Interoceptive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jun 2025to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 conducted at 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. All participants will complete a semi-structured exit interview to provide feedback on their experience of participating in ADIE Therapy. Participants who complete the study will be invited to take part in an optional three-month follow-up assessment (Week 18), which repeats the same interoceptive tasks and questionnaires to evaluate longer-term effects of the therapy.
The present study is an open-label, single-arm acceptability and feasibility study. The investigators aim to recruit a total of 20 participants.
- Conditions
- Cancer, Primary Breast Cancer
- Being tested
- Interoceptive training
- Keywords
- Breast Cancer, Primary Breast Cancer, ADIE Therapy, Biobehavioral Medicine, Anxiety Management, Interoception, Emotion Regulation, Interoceptive Training, Cardiac Interoception, Mind-Body Therapy
- Medical subject headings
- Neoplasms, Breast Neoplasms, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interoceptive trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ADIE Therapy | Experimental | Participants will undergo 6 sessions of cardiac interoceptive training (ADIE Therapy). Receives: Behavioral: Interoceptive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline through Post-Treatment (Week 7)
Secondary outcomes (14)
Cardiac Interoceptive Accuracy, Awareness, and Sensibility Scores
Interoceptive outcomes will be assessed using heartbeat detection tasks to evaluate three domains of cardiac interoception:
- Accuracy (objective performance on heartbeat detection tasks)
- Sensibility (subjective confidence or perception of performance)
- 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.
Measured: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Generalized Anxiety Disorder (GAD-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.
Measured: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Spielberger State-Trait Anxiety Inventory (STAI)
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.
Measured: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Patient Health Questionnaire (PHQ-8)
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.
Measured: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Anxiety Sensitivity Index (ASI)
The ASI evaluates concerns about anxiety and its potential consequences. The ASI is comprised of 16 items rated on a four-point scale.
Measured: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Toronto Alexithymia Scale (TAS-20)
The TAS-20 assesses difficulty in identifying and describing emotions. The TAS-20 consists of 20 items rated on a four-point scale.
Measured: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Fear of Cancer Recurrence Inventory - Short Form (FCRI-SF)
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.
Measured: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Body Perceptions Questionnaire (BPQ) - Body Awareness Short Form
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.
Measured: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
The MAIA-2 assesses various dimensions of interoception with 37 items. It contains 8 subscales assessing 5 dimensions of body awareness.
Measured: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Bodily Threat Monitoring Scale (BTMS)
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.
Measured: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Body Mindset Inventory - Version 2 (BMI-2)
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.
Measured: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
EuroQoL 5 Dimensions, 5 Levels (EQ-5D-5L)
The EQ-5D-5L measures five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
Measured: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Pain Intensity, Interference, and Body Location
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.
Measured: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Patient Global Impression of Change (PGIC) Scale
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.
Measured: Post-Treatment (Week 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start13 Jun 2025
- Primary completion18 Dec 2025
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label, single arm pilot study, in which all participants will receive ADIE Therapy.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London, Brighton & Sussex Medical School
- Responsible party
- Sponsor
- Investigators
- Lauren C. Heathcote, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954532
- Sponsor's protocol ID
- HR/DP-23/24-41430
- Acronym
- ADIE-BC
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD will be shared with other researchers to comply with open science practices.
Publications
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.
PubMed 34401684
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADIE-BC - Aligning Dimensions of Interoceptive Experience in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT06954532
- Acronym / sponsor ID
- ADIE-BC / HR/DP-23/24-41430
- Conditions
- Cancer, Primary Breast Cancer
- Keywords
- Breast Cancer, Primary Breast Cancer, ADIE Therapy, Biobehavioral Medicine, Anxiety Management, Interoception, Emotion Regulation, Interoceptive Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- University College, London, Brighton & Sussex Medical School
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 conducted at 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. All participants will complete a semi-structured exit interview to provide feedback on their experience of participating in ADIE Therapy. Participants who complete the study will be invited to take part in an optional three-month follow-up assessment (Week 18), which repeats the same interoceptive tasks and questionnaires to evaluate longer-term effects of the therapy.
The present study is an open-label, single-arm acceptability and feasibility study. The investigators aim to recruit a total of 20 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, single arm pilot study, in which all participants will receive ADIE Therapy.
| Arm | Type | Receives |
|---|---|---|
| ADIE Therapy | Experimental | Behavioral: Interoceptive trainingParticipants will undergo 6 sessions of cardiac interoceptive training (ADIE Therapy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interoceptive trainingThere 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. | Behavioural | ADIE Therapy |
Primary outcome
Acceptability of the Intervention - Theoretical Framework of Acceptability (TFA) Questionnaire
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
14 secondary outcomes
Cardiac Interoceptive Accuracy, Awareness, and Sensibility Scores
Time frame: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Generalized Anxiety Disorder (GAD-7)
Time frame: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Spielberger State-Trait Anxiety Inventory (STAI)
Time frame: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Patient Health Questionnaire (PHQ-8)
Time frame: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Anxiety Sensitivity Index (ASI)
Time frame: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Toronto Alexithymia Scale (TAS-20)
Time frame: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Fear of Cancer Recurrence Inventory - Short Form (FCRI-SF)
Time frame: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Body Perceptions Questionnaire (BPQ) - Body Awareness Short Form
Time frame: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
Time frame: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Bodily Threat Monitoring Scale (BTMS)
Time frame: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Body Mindset Inventory - Version 2 (BMI-2)
Time frame: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
EuroQoL 5 Dimensions, 5 Levels (EQ-5D-5L)
Time frame: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Pain Intensity, Interference, and Body Location
Time frame: Baseline, Midpoint (Week 4), Post-Treatment (Week 7), and 3-month Follow-Up (Week 18; optional)
Patient Global Impression of Change (PGIC) Scale
Time frame: Post-Treatment (Week 7)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Background: PubMed 34401684Quadt 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.
- Individual participant dataSharing planned: Yes. De-identified IPD will be shared with other researchers to comply with open science practices.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren C. Heathcote, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interoceptive training in people with Cancer and Primary Breast Cancer, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the Intervention - Theoretical Framework of Acceptability (TFA) Questionnaire (time frame: Post-Treatment (Week 7)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06954532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.