The Modulatory Role of Internet MBCT on Extracellular Vesicles and Distress in Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-03

Study Completion Date

2024-03-31

Brief Summary

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Mindfulness-based interventions (MBIs), such as mindfulness-based stress reduction (MBSR), mindfulness-based cognitive therapy (MBCT), mindfulness-based cancer recovery (MBCR), have been showing promising results in different health-related and psychosocial outcomes in the context of cancer. More recently, the possibility of delivering MBIs using technological tools and resources, such as internet and applications, has been receiving much attention, also accompanied by promising findings. However, few randomized controlled studies have been conducted and published to date. Moreover, few studies have addressed the long-term stability and trajectory of gains across time. Also, even though prior evidence had suggested that face-to-face MBIs might modulate several biological markers (e.g., pro-inflammatory gene expression and inflammatory signaling; telomere length), as far as we know, no previous study addressed the impact of online MBIs on biological indices, especially on extracellular vesicles (EVs).

As primary objective, this study aims to investigate the effects of an internet-based MBCT intervention (vs. Treatment as Usual - TAU) on EVs (objective measure), as well as on psychological distress (subjective measure), considering a sample of distressed people with history of breast, prostate, and colorectal cancer.

As secondary objective, this study aims to investigate the effects of this same intervention on psychosocial outcomes, including quality of life, fear of cancer recurrence, emotion suppression, mindfulness, sleep quality, posttraumatic growth, health-related behaviours (physical activity; smoking habits), and perceived social support. The biological secondary outcomes studied will be: inflammatory response genes interleukins (ILs, IL-1, IL-6, IL-8, IL-10), interferon gamma (IFN-γ), tumour necrosis factor (TNF), and c-reactive protein (CRP); telomerase activity; antigens related to cancer (cancer antigen - CA 15-3; prostate-specific antigen - PSA; carcinoembryonic antigen - CEA); other health-related markers (adrenocorticotropic hormone - ACTH; erythrocytes number; hemoglobin glycosylated).

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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

At baseline, everyone (participants, study coordinator, mindfulness instructor(s), research assistant, and statistician) will be blinded to conditions as it is expected to occur before randomization. Once participants are randomized, the study coordinator will inform them of the group assignments, and all of them will become unblinded to the conditions. Due to the specificities of this type of study and intervention, it is not possible to guarantee the blinding of personnel and participants.

Study Groups

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Mindfulness Based Cognitive Therapy (MBCT)

Group intervention on Mindfulness-Based Cognitive Therapy classic program plus 4 monthly consolidation sessions of 90 minutes each.

Group Type EXPERIMENTAL

Mindfulness Based Cognitive Therapy (MBCT)

Intervention Type BEHAVIORAL

Experimental group: MBCT is program developed by Zindel Segal, Mark Williams, and John Teasdale , based on Jon Kabat-Zinn's Mindfulness-based Stress Reduction (MBSR) program. Participants learn to acknowledge their unhelpful thoughts and feelings, allowing the mind to move from an automatic and spiraling thought pattern to a more conscious emotional processing. Mindfulness practices include breath awareness, sitting and walking meditations, and mindful yoga. In this study, the following MBCT structure will be followed: group setting of 12 participants (maximum); 8 online weekly meetings of 2 hours via a videoconference platform (e.g., Cisco Webex), each one mediated by a trained mindfulness instructor(s); daily home practice of the learned skills; 2 hours of retreat after the fifth week; 6 months of home practice; 4 monthly consolidation sessions of 90 minutes each.

Treatment as Usual (TAU)

TAU will be the control condition.

Group Type OTHER

Treatment as Usual

Intervention Type OTHER

In this case, participants will follow the usual institutional intervention protocol for medical follow-up and identification, referral, and intervention for people with significant distress difficulties. Regarding pharmacological intervention, medication intake will be monitored during the study and changes will be registered. The engagement in non-pharmacological interventions such as psychological and psychosocial interventions will also be monitored.

Interventions

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Mindfulness Based Cognitive Therapy (MBCT)

Experimental group: MBCT is program developed by Zindel Segal, Mark Williams, and John Teasdale , based on Jon Kabat-Zinn's Mindfulness-based Stress Reduction (MBSR) program. Participants learn to acknowledge their unhelpful thoughts and feelings, allowing the mind to move from an automatic and spiraling thought pattern to a more conscious emotional processing. Mindfulness practices include breath awareness, sitting and walking meditations, and mindful yoga. In this study, the following MBCT structure will be followed: group setting of 12 participants (maximum); 8 online weekly meetings of 2 hours via a videoconference platform (e.g., Cisco Webex), each one mediated by a trained mindfulness instructor(s); daily home practice of the learned skills; 2 hours of retreat after the fifth week; 6 months of home practice; 4 monthly consolidation sessions of 90 minutes each.

Intervention Type BEHAVIORAL

Treatment as Usual

In this case, participants will follow the usual institutional intervention protocol for medical follow-up and identification, referral, and intervention for people with significant distress difficulties. Regarding pharmacological intervention, medication intake will be monitored during the study and changes will be registered. The engagement in non-pharmacological interventions such as psychological and psychosocial interventions will also be monitored.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of breast, prostate, or colorectal cancer;
* Cancer stage I - III;
* Primary cancer treatments completed between 3 months and 5 years (participants with ongoing adjuvant hormonal therapies will be included);
* Age between 18 and 65 years;
* Experiencing significant distress on the Distress Thermometer (DT ≥ 4)
* Willingness to accept randomization to one of the two study conditions and to attend the study for its duration;
* Ability to speak, read, and write in Portuguese and literacy to complete autonomously the self-report measures;
* Sufficient digital literacy with access to a device (e.g., smartphone; tablet; computer) with camera, microphone, and internet.

Exclusion Criteria

* Concurrent diagnosis of severe psychiatric condition(s) (e.g., psychosis; substance abuse; bipolar disorder; suicidal ideation);
* Concurrent diagnosis of autoimmune disorder;
* Current use of antipsychotics;
* Current use of anti-inflammatory medication (corticotherapy);
* Undergoing trastuzumab therapy;
* Participation in a structured mindfulness program (e.g., MBCT; MBSR; Mindfulness-Based Cancer Recovery - MBCR) program in the past five years;
* Currently attending psychological consultation;
* Being pregnant or breastfeeding.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No