Evidence map›Paper›PMID 35123569›Full record

ArticleTrials2022

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.

Diana R Pereira, Eunice R Silva, Carina Carvalho-Maia, Sara Monteiro-Reis, Catarina Lourenço, Rita Calisto, Ricardo João Teixeira, Linda E Carlson, Genevieve Bart, Seppo J Vainio and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04727593 (The Modulatory Role of Internet-supported Mindfulness-based Cognitive Therapy on Extracellular Vesicles and Psychological Distress in People Who Have Had Cancer), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 35% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04727593 naunknown statusnot on this map

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

TypeinterventionalSponsorInstituto Portugues de Oncologia, Francisco Gentil, PortoRan2021 to 2024Enrolled111ConditionsCancerArmsMindfulness Based Cognitive Therapy (MBCT), Treatment as Usual
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 3 countries.

Diana R PereiraPsychology Service, Portuguese Oncology Institute of Porto (IPOP), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal. diana.r.pereira@gmail.com.ORCID http://orcid.org/0000-0002-3190-9298
Eunice R SilvaPsychology Service, Portuguese Oncology Institute of Porto (IPOP), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal. esilva@ipoporto.min-saude.pt.
Carina Carvalho-MaiaRISE@CI-IPOP (Health Research Network), Portuguese Oncology Institute of Porto (IPOP), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal.
Sara Monteiro-ReisRISE@CI-IPOP (Health Research Network), Portuguese Oncology Institute of Porto (IPOP), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal.
Catarina LourençoRISE@CI-IPOP (Health Research Network), Portuguese Oncology Institute of Porto (IPOP), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal.
Rita CalistoCancer Epidemiology Group-Research Center, Portuguese Oncology Institute of Porto (IPOP), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal.
Ricardo João TeixeiraCINEICC, Faculty of Psychology and Educational Sciences, University of Coimbra, Rua do Colégio Novo, 3000-115, Coimbra, Portugal.
Linda E CarlsonDepartment of Oncology, University of Calgary, Calgary, AB, T2N 3C1, Canada.
Genevieve BartDisease Networks Research Unit, Laboratory of Developmental Biology, Faculty of Biochemistry and Molecular Medicine, Infotech Oulu, Kvantum Institute, University of Oulu, 90570, Oulu, Finland.
Seppo J VainioDisease Networks Research Unit, Laboratory of Developmental Biology, Faculty of Biochemistry and Molecular Medicine, Infotech Oulu, Kvantum Institute, University of Oulu, 90570, Oulu, Finland.
M Goreti F SalesBioMark@UC, Department of Chemical Engineering, Faculty of Sciences and Technology, University of Coimbra, Rua Sílvio Lima, 3030-790, Coimbra, Portugal.
Carmen JerónimoRISE@CI-IPOP (Health Research Network), Portuguese Oncology Institute of Porto (IPOP), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal.
Rui HenriqueRISE@CI-IPOP (Health Research Network), Portuguese Oncology Institute of Porto (IPOP), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal.
Instituto Português de Oncologia Francisco Gentil · PTUniversidade do Porto · PTUniversity of Oulu · FIUniversity of Calgary · CAUniversity of Coimbra · PT

Funding

H2020 European Research Council 829040
6 · The paper itself

Abstract

backgroundMindfulness-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.

methodsThe 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 registrationClinicalTrials.gov NCT04727593 (date of registration: 27 January 2021; date of record verification: 6 October 2021).

Indexed as

Cognitive Behavioral TherapyExtracellular VesiclesInternet-Based InterventionMindfulnessNeoplasmsPsychological DistressAdolescentAdultAgedHumansMaleMiddle AgedRandomized Controlled Trials as TopicTreatment OutcomeYoung AdultCancerDistressExtracellular vesiclesInternetMindfulness-based cognitive therapyMindfulness-based interventionOnlineRandomized controlled trial

Identifiers

PMID35123569
PMCPMC8817152
OpenAlexW4220935497

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.