NCT04727593

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

The Modulatory Role of Internet-supported Mindfulness-based Cognitive Therapy on Extracellular Vesicles and Psychological Distress in People Who Have Had Cancer: A Study Protocol for a Two-armed Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (estimated)
• Sponsor: Instituto Portugues de Oncologia, Francisco Gentil, Porto · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 promising results in different health-related and psychosocial outcomes in the context of cancer. More recently, the possibility of delivering MBIs using technological tools and resources, such as internet and applications, has been receiving much attention, also accompanied by promising findings. However, few randomized controlled studies have been conducted and published to date. Moreover, few studies have addressed the long-term stability and trajectory of gains across time. Also, even though prior evidence had suggested that face-to-face MBIs might modulate several biological markers (e.g., pro-inflammatory gene expression and inflammatory signaling; telomere length), as far as we know, no previous study addressed the impact of online MBIs on biological indices, especially on extracellular vesicles (EVs). As primary objective, this study aims to investigate the effects of an internet-based MBCT intervention (vs. Treatment as Usual - TAU) on EVs (objective measure), as well as on psychological distress (subjective measure), considering a sample of distressed people with history of breast, prostate, and colorectal cancer. As secondary objective, this study aims to investigate the effects of this same intervention on psychosocial outcomes, including quality of life, fear of cancer recurrence, emotion suppression, mindfulness, sleep quality, posttraumatic growth, health-related behaviours (physical activity; smoking habits), and perceived social support. The biological secondary outcomes studied will be: inflammatory response genes interleukins (ILs, IL-1, IL-6, IL-8, IL-10), interferon gamma (IFN-γ), tumour necrosis factor (TNF), and c-reactive protein (CRP); telomerase activity; antigens related to cancer (cancer antigen - CA 15-3; prostate-specific antigen - PSA; carcinoembryonic antigen - CEA); other health-related markers (adrenocorticotropic hormone - ACTH; erythrocytes number; hemoglobin glycosylated).

Conditions

• Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness Based Cognitive Therapy (MBCT)	Experimental group: MBCT is program developed by Zindel Segal, Mark Williams, and John Teasdale , based on Jon Kabat-Zinn's Mindfulness-based Stress Reduction (MBSR) program. Participants learn to acknowledge their unhelpful thoughts and feelings, allowing the mind to move from an automatic and spiraling thought pattern to a more conscious emotional processing. Mindfulness practices include breath awareness, sitting and walking meditations, and mindful yoga. In this study, the following MBCT structure will be followed: group setting of 12 participants (maximum); 8 online weekly meetings of 2 hours via a videoconference platform (e.g., Cisco Webex), each one mediated by a trained mindfulness instructor(s); daily home practice of the learned skills; 2 hours of retreat after the fifth week; 6 months of home practice; 4 monthly consolidation sessions of 90 minutes each.
OTHER	Treatment as Usual	In this case, participants will follow the usual institutional intervention protocol for medical follow-up and identification, referral, and intervention for people with significant distress difficulties. Regarding pharmacological intervention, medication intake will be monitored during the study and changes will be registered. The engagement in non-pharmacological interventions such as psychological and psychosocial interventions will also be monitored.

Timeline

• Start date: 2021-09-03
• Primary completion: 2024-03-01
• Completion: 2024-03-31
• First posted: 2021-01-27
• Last updated: 2023-09-05

Locations

1 site across 1 country: Portugal