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.DiscussionThis 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.govNCT04727593 (date of registration: 27 January 2021; date of record verification: 6 October 2021).
Highlights
Cancer remains one of the leading causes of death and accounted for 19.3 million new cases and 9.9 million deaths worldwide in 2020 [1, 2]
This study will allow characterizing the effects of internet-based mindfulness-based cognitive therapy (MBCT) on psychosocial and biological indicators in the context of cancer
Distress is among the main factors that negatively affect the quality of life of cancer patients, regardless of the type of cancer or the stage of disease progression [3,4,5,6]
Summary
Cancer remains one of the leading causes of death and accounted for 19.3 million new cases and 9.9 million deaths worldwide in 2020 [1, 2]. Survival rates are increasing due to major advances in cancer diagnosis, treatment, and follow-up, which means that cancer will increasingly impact the lives of many people This creates a need to control disease progression and recovery pathways to optimize the well-being, quality of life, and daily functioning of people with cancer. Distress involves various experiences (e.g. anxiety; depression; fear; rumination) that vary from person to person and over time [5, 7] This is a common experience in people with cancer from the time of diagnosis through disease remission and long-term survivorship [4]. The lack of RCTs is even more limited within the context of technology-mediated MBIs and long-term effects.
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