The modulatory role of internet-supported mindfulness-based cognitive therapy on extracellular vesicles and psychological distress in people who have had cancer: a protocol for a two-armed randomized controlled study

Table 1 Eligibility criteria

Inclusion	Exclusion
• Age between 18 and 65 years old* • Diagnosis of breast, prostate, or colorectal cancer (cancer stage I to III) • Primary cancer treatments completed between 3 months to 5 years previously (ongoing hormonal therapy will be included) • Experience of significant distress at the time of inclusion (DT ≥ 4) • Willingness to accept randomization to one of the two study conditions and participation in the intervention and data collection for the duration of the study • Ability to speak, read, and write in Portuguese and literacy to autonomously complete the self-report measure • Sufficient digital literacy and access to a device (e.g. smartphone; tablet; computer) with a camera, microphone, and internet	• Concurrent diagnosis of severe psychiatric condition(s) (e.g. bipolar disorder; psychosis; substance abuse; suicidal ideation) • Concurrent diagnosis of autoimmune disorder • Current use of antipsychotics • Current use of anti-inflammatory medication (e.g. corticotherapy) • Ongoing trastuzumab therapy • Participation in a structured mindfulness programme (e.g. MBCR; MBCT; MBSR) in the past 5 years • Currently attending psychological consultation • Being pregnant or breastfeeding

Note. DT distress thermometer, MBCR mindfulness-based cancer recovery, MBCT mindfulness-based cognitive therapy, MBSR mindfulness-based stress reduction. *This age criterion was considered due to other study of the MindGAP project in which healthy blood donors reporting low psychological distress will be compared with distressed participants diagnosed with cancer for a better characterization of the CNS-EVs. This characterization is important given that CNS-EVs are a novel approach in both healthy and clinical groups. As blood donors are aged between 18 and 65 years, the same criterion was applied to the participants diagnosed with cancer to have a closer age match between groups

ISSN: 1745-6215