Cited by 6Mindfulness and Compassion InterventionsCancer survivorship and careDigital Mental Health Interventions

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

Open access
Pereira, Diana R., Silva, Eunice R., Carvalho-Maia, Carina, Monteiro-Reis, Sara, Lourenço, Catarina, Calisto, Rita, Teixeira, Ricardo João, Carlson, Linda E. +5 more·2022·Trials

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Abstract

Background: Mindfulness-based interventions (MBIs) have been used in oncology contexts as a promising tool with numerous benefits for various health-related and psychosocial outcomes. Despite the increasing popularity of MBIs, few randomized controlled trials (RCTs) have examined their effects upon biological parameters. Specifically, no previous study has examined the effects of MBIs on extracellular vesicles (EVs), which are potentially important markers of health, disease, and stress. Moreover, the lack of RCTs is even more limited within the context of technology-mediated MBIs and long-term effects. Methods: The current study protocol presents a two-arm, parallel, randomized controlled study investigating the effects of internet-supported mindfulness-based cognitive therapy (MBCT) compared with treatment as usual (TAU). Primary outcomes are psychological distress and EV cargo of distressed participants with previous breast, colorectal, or prostate cancer diagnoses. Secondary outcomes are self-reported psychosocial and health-related measures, and additional biological markers. Outcomes will be assessed at baseline, 4 weeks after baseline (mid-point of the intervention), 8 weeks after baseline (immediately post-intervention), 24 weeks after baseline (after booster sessions), and 52 weeks after baseline. Our goal is to recruit at least 111 participants who have been diagnosed with breast, prostate, or colorectal cancer (cancer stage I to III), are between 18 and 65 years old, and have had primary cancer treatments completed between 3 months and 5 years ago. Half of the participants will be randomized to the TAU group, and the other half will participate in an 8-week online MBCT intervention with weekly group sessions via videoconference. The intervention also includes asynchronous homework, an online retreat after the fifth week, and 4 monthly booster sessions after completion of the 8-week programme. Discussion: This study will allow characterizing the effects of internet-based MBCT on psychosocial and biological indicators in the context of cancer. The effects on circulating EVs will also be investigated, as a possible neurobiological pathway underlying mind-body intervention effects. Trial registration: ClinicalTrials.gov NCT04727593 (date of registration: 27 January 2021; date of record verification: 6 October 2021).

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Authors
Pereira, D. R., Silva, E. R., Carvalho-Maia, C., Monteiro-Reis, S., Lourenço, C., Calisto, R., Teixeira, R. J., Carlson, L. E., Bart, G., Vainio, S. J., Sales, M. G. F., Jerónimo, C., & Henrique, R.
Affiliations
  • IPO Porto (PT)
  • University of Coimbra (PT)
  • University of Calgary (CA)
  • Infotech Oulu (FI)
  • Universidade do Porto (PT)
Corresponding author
  • Pereira, Diana R.
  • Silva, Eunice R.
Venue
Trials
Published
2022-02-05
Volume
23
Issue
1
Pages
118-118
ISSN
1745-6215 (ISSN-L)
OpenAlex
W4220935497
Cited by
6
References
135
Citations by year
2026: 1 · 2025: 1 · 2024: 1 · 2023: 2 · 2022: 1
FWCI
1.14
Type
journal article
Language
en
Open access
Locations
  • Trials (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Estudo Geral (Universidad de Coimbra) (submittedVersion, cc-by)
  • Portuguese National Funding Agency for Science, Research and Technology (RCAAP Project by FCT) (submittedVersion, other-oa)
  • Libraries and Cultural Resources (University of Calgary) (submittedVersion)
Funders
H2020 European Research Council (829040)
Topics
  • Social Sciences › Psychology › Clinical Psychology › Mindfulness and Compassion Interventions
  • Health Sciences › Medicine › Oncology › Cancer survivorship and care
  • Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
Keywords
mindfulness-based cognitive therapy, online intervention, extracellular vesicles, psychological distress, cancer survivors, breast cancer, colorectal cancer, prostate cancer, online therapy, booster sessions, mind-body interventions, neurobiological markers, psychosocial outcomes
MeSH terms
Extracellular Vesicles, Psychological Distress, Internet-Based Intervention, Adolescent, Adult, Aged, Humans, Male, Middle Aged, Neoplasms, Cognitive Behavioral Therapy, Randomized Controlled Trials as Topic, Treatment Outcome, Young Adult, Mindfulness

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