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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 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 will be evaluated by examining mean promoter score (measured on 10-point Likert scale) post intervention. Range 0-10 (higher scores indicate more acceptability).
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.
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.
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.
Saliva and blood samples will be collected pre-treatment and post-treatment (Week 7) to explore the feasibility of incorporating biomarker collection into the ADIE-BC research protocol.
Adverse events will be monitored using a protocol adapted from Wileman et al. (2024) for digital trials. Participants will complete structured questions assessing physical, psychological, or other adverse events at post-treatment (Week 7). An open-text form will also be available throughout the study, allowing participants to report any adverse experiences at any time.
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.
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.
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.
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.
The ASI evaluates concerns about anxiety and its potential consequences. The ASI is comprised of 16 items rated on a four-point scale.
The TAS-20 assesses difficulty in identifying and describing emotions. The TAS-20 consists of 20 items rated on a four-point scale.
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.
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.
The MAIA-2 assesses various dimensions of interoception with 37 items. It contains 8 subscales assessing 5 dimensions of body awareness.
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.
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.
The EQ-5D-5L measures five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
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.