The Modulatory Role of Internet MBCT on Extracellular Vesicles and Distress in Cancer Patients - Study Protocol

Launched by INSTITUTO PORTUGUES DE ONCOLOGIA, FRANCISCO GENTIL, PORTO · Jan 26, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring how an online mindfulness-based therapy called Mindfulness-Based Cognitive Therapy (MBCT) can help cancer patients who are feeling distressed. The study compares the effects of MBCT delivered over the internet to standard treatment (Treatment as Usual) for people who have had breast, prostate, or colorectal cancer. Researchers want to see if participating in this online program can improve both emotional well-being and specific biological markers in the body, such as tiny particles called extracellular vesicles (EVs) that may indicate stress or inflammation.

To join the study, participants should be between 18 and 65 years old, have completed their primary cancer treatments within the last 3 to 5 years, and experience significant distress. They also need to be comfortable using digital devices like smartphones or computers to attend the online sessions. Throughout the trial, participants can expect to engage in mindfulness exercises that may help reduce their stress and improve their overall quality of life. It’s important to know that individuals with severe psychiatric conditions or certain other medical issues, like autoimmune disorders, cannot participate in this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of breast, prostate, or colorectal cancer;
• • Cancer stage I - III;
• • Primary cancer treatments completed between 3 months and 5 years (participants with ongoing adjuvant hormonal therapies will be included);
• • Age between 18 and 65 years;
• • Experiencing significant distress on the Distress Thermometer (DT ≥ 4)
• • Willingness to accept randomization to one of the two study conditions and to attend the study for its duration;
• • Ability to speak, read, and write in Portuguese and literacy to complete autonomously the self-report measures;
• • Sufficient digital literacy with access to a device (e.g., smartphone; tablet; computer) with camera, microphone, and internet.
• Exclusion Criteria:
• • Concurrent diagnosis of severe psychiatric condition(s) (e.g., psychosis; substance abuse; bipolar disorder; suicidal ideation);
• • Concurrent diagnosis of autoimmune disorder;
• • Current use of antipsychotics;
• • Current use of anti-inflammatory medication (corticotherapy);
• • Undergoing trastuzumab therapy;
• • Participation in a structured mindfulness program (e.g., MBCT; MBSR; Mindfulness-Based Cancer Recovery - MBCR) program in the past five years;
• • Currently attending psychological consultation;
• • Being pregnant or breastfeeding.