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.
Study Goal
The researchers aimed to investigate the effects of internet-supported mindfulness-based cognitive therapy (MBCT) on psychological distress and extracellular vesicles (EVs) in cancer survivors, comparing it to treatment as usual (TAU).
Results Summary
The study protocol outlines a planned investigation but does not report results; it focuses on assessing MBCT's impact on psychosocial and biological markers, including EVs, at multiple time points up to 52 weeks.
Population
Adults aged 18-65 with previous diagnoses of breast, prostate, or colorectal cancer (stage I-III), who completed primary cancer treatments 3 months to 5 years prior.
Effective Dosage
8-week online MBCT intervention with weekly group sessions, asynchronous homework, an online retreat after the fifth week, and 4 monthly booster sessions.
Duration
8 weeks (with follow-ups at 24 and 52 weeks).
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Mindfulness-based interventions (MBIs) | neutral | various health-related and psychosocial outcomes | oncology contexts | - | have been used as a promising tool with numerous benefits | #1 |
internet-supported mindfulness-based cognitive therapy (MBCT) | neutral | psychological distress | distressed participants with previous breast, colorectal, or prostate cancer diagnoses | - | investigating the effects | #2 |
internet-supported mindfulness-based cognitive therapy (MBCT) | neutral | EV cargo | distressed participants with previous breast, colorectal, or prostate cancer diagnoses | - | investigating the effects | #3 |
internet-based MBCT | neutral | psychosocial indicators | in the context of cancer | - | characterizing the effects | #4 |
internet-based MBCT | neutral | biological indicators | in the context of cancer | - | characterizing the effects | #5 |
mind-body intervention | neutral | circulating EVs | - | - | underlying effects | #6 |
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).