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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, Diana R; Silva, Eunice R; Carvalho-Maia, Carina; Monteiro-Reis, Sara; Lourenço, Catarina; Calisto, Rita; Teixeira, Ricardo João; Carlson, Linda E; Bart, Genevieve; Vainio, Seppo J; Sales, M Goreti F; Jerónimo, Carmen; Henrique, Rui.
Afiliación
  • Pereira DR; Psychology Service, Portuguese Oncology Institute of Porto (IPOP), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal. diana.r.pereira@gmail.com.
  • Silva ER; Cancer Genetics Group, Research Centre of Portuguese Oncology Institute of Porto (CI-IPOP), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal. diana.r.pereira@gmail.com.
  • Carvalho-Maia C; RISE@CI-IPOP (Health Research Network), Portuguese Oncology Institute of Porto (IPOP), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal. diana.r.pereira@gmail.com.
  • Monteiro-Reis S; Porto Comprehensive Cancer Centre (Porto.CCC), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal. diana.r.pereira@gmail.com.
  • Lourenço C; Psychology Service, Portuguese Oncology Institute of Porto (IPOP), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal. esilva@ipoporto.min-saude.pt.
  • Calisto R; Cancer Genetics Group, Research Centre of Portuguese Oncology Institute of Porto (CI-IPOP), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal. esilva@ipoporto.min-saude.pt.
  • Teixeira RJ; RISE@CI-IPOP (Health Research Network), Portuguese Oncology Institute of Porto (IPOP), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal. esilva@ipoporto.min-saude.pt.
  • Carlson LE; Porto Comprehensive Cancer Centre (Porto.CCC), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal. esilva@ipoporto.min-saude.pt.
  • Bart G; RISE@CI-IPOP (Health Research Network), Portuguese Oncology Institute of Porto (IPOP), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal.
  • Vainio SJ; Porto Comprehensive Cancer Centre (Porto.CCC), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal.
  • Sales MGF; Cancer Biology and Epigenetics Group, IPO Porto Research Center (GEBC CI-IPOP), Portuguese Oncology Institute of Porto (IPOP), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal.
  • Jerónimo C; RISE@CI-IPOP (Health Research Network), Portuguese Oncology Institute of Porto (IPOP), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal.
  • Henrique R; Porto Comprehensive Cancer Centre (Porto.CCC), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal.
Trials ; 23(1): 118, 2022 Feb 05.
Article en En | MEDLINE | ID: mdl-35123569
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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Contexto en salud: 1_ASSA2030 / 2_ODS3 Problema de salud: 1_doencas_nao_transmissiveis / 2_muertes_prematuras_enfermedades_notrasmisibles Asunto principal: Terapia Cognitivo-Conductual / Atención Plena / Vesículas Extracelulares / Intervención basada en la Internet / Distrés Psicológico / Neoplasias Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline Límite: Adolescent / Adult / Aged / Humans / Male / Middle aged Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2022 Tipo del documento: Article País de afiliación: Portugal

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Contexto en salud: 1_ASSA2030 / 2_ODS3 Problema de salud: 1_doencas_nao_transmissiveis / 2_muertes_prematuras_enfermedades_notrasmisibles Asunto principal: Terapia Cognitivo-Conductual / Atención Plena / Vesículas Extracelulares / Intervención basada en la Internet / Distrés Psicológico / Neoplasias Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline Límite: Adolescent / Adult / Aged / Humans / Male / Middle aged Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2022 Tipo del documento: Article País de afiliación: Portugal
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