Status:
UNKNOWN
The Modulatory Role of Internet MBCT on Extracellular Vesicles and Distress in Cancer Patients - Study Protocol
Lead Sponsor:
Instituto Portugues de Oncologia, Francisco Gentil, Porto
Collaborating Sponsors:
European Commission
University of Coimbra
Conditions:
Cancer
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Mindfulness-based interventions (MBIs), such as mindfulness-based stress reduction (MBSR), mindfulness-based cognitive therapy (MBCT), mindfulness-based cancer recovery (MBCR), have been showing promi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2024
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT04727593
Start Date
September 3 2021
End Date
March 31 2024
Last Update
September 5 2023
Active Locations (1)
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1
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, Portugal, 4200-072