NCT04727593: MINDGAP

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

Status unknown NA Last updated 5 September 2023

What this trial tests

NA trial testing Mindfulness Based Cognitive Therapy (MBCT) in Cancer in 111 participants. Status unknown.

Timeline

3 September 2021

Primary endpoint
1 March 2024

31 March 2024

Quick facts

Lead sponsor	Instituto Portugues de Oncologia, Francisco Gentil, Porto
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	111
Start date	3 September 2021
Primary completion	1 March 2024
Estimated completion	31 March 2024
Sites	1 location across Portugal

Drugs / interventions tested

• Mindfulness Based Cognitive Therapy (MBCT)
• Treatment as Usual

Conditions studied

• Cancer — all drugs for Cancer →

Sponsor

Instituto Portugues de Oncologia, Francisco Gentil, Porto

Who can join

Adults 18 to 65, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Extracellular Vesicles in cancer: from isolation and characterization to metastasis, drug resistance, and clinical applications.
   Jurj A, Paul D, Calin GA. · · 2025 · cited 4× · PMID 40629268 · DOI 10.1186/s12885-025-14375-7
2. 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.
   Pereira DR, Silva ER, Carvalho-Maia C, Monteiro-Reis S, et al · · 2022 · cited 3× · PMID 35123569 · DOI 10.1186/s13063-022-06045-x
3. Potential Effect of Extracellular Vesicles in Clinical Settings of Lymphoma.
   Mamgain G, Yadav SRM. · · 2025 · PMID 39835236 · DOI 10.1007/s12291-023-01156-x
4. 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
   Pereira D, Silva ER, Carvalho-Maia C, Monteiro-Reis S, et al · · 2021 · DOI 10.21203/rs.3.rs-968587/v1