The Modulatory Role of Internet MBCT on Extracellular Vesicles and Distress in Cancer Patients - Study Protocol (MINDGAP)

September 1, 2023 updated by: Instituto Portugues de Oncologia, Francisco Gentil, Porto

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
111

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindfulness Based Cognitive Therapy (MBCT)
Group intervention on Mindfulness-Based Cognitive Therapy classic program plus 4 monthly consolidation sessions of 90 minutes each.
Behavioral: 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.
Other: Treatment as Usual (TAU)
TAU will be the control condition.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change on Extracellular Vesicles
Time Frame: T1 - before intervention; 8 weeks after T1; 24 weeks after T1
Isolated by ultracentrifugation with sucrose cushion. The collected EVs will be quantified by Nanoparticle tracking analysis (Nanosight Ltd.), and data will be measured in particles per milliliter (mL).
T1 - before intervention; 8 weeks after T1; 24 weeks after T1
Change on Distress
Time Frame: T1- before intervention; T2 - 4 weeks after baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Measured with Depression Anxiety Stress Scales-21 - DASS-21, a self-report and public domain questionnaire that evaluates negative affective states. It is composed of 21 items, 7 focused on depression, 7 on anxiety, and 7 on stress. Each item is rated on a 4-point Likert-type scale, wherein in 0 represents "did not apply to me at all" and 3 represents "applied to me very much or most of the time". The score for each subscale ranges between 0 and 21. In the current study, a total score will be computed by summing all items, with higher scores being indicative of higher self-reported psychological distress.
T1- before intervention; T2 - 4 weeks after baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change on Cancer antigen 15-3 (CA 15-3)
Time Frame: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Using an immunoassay analyser (units/mL).
T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Change on Prostate-specific antigen (PSA)
Time Frame: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Using an immunoassay analyser (ng/mL).
T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Change on Carcinoembryonic Antigen (CEA).
Time Frame: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Using an immunoassay analyser (ng/mL).
T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Change on Adrenocorticotropic Hormone (ACTH).
Time Frame: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Using an immunoassay analyser (pg/mL).
T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Transcript inflammatory response genes (Interleukins, ILs, IL-1, IL-6, IL-8, IL-10, IFNγ and TNF).
Time Frame: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Assessed by quantitative RT-PCR (TaqMan™ Gene Expression Assays).
T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Change on Analytic biomarkers (Erythrocyte number).
Time Frame: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
This indicator assesses erythrocytes number (million/mm3) from blood samples (Sysmex XN).
T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Change on Analytic biomarkers (PCR number).
Time Frame: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
This indicator assesses PCR (mg/L) from blood samples.
T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Change on Analytic biomarkers (telomerase activity).
Time Frame: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
This indicator assesses telomerase activity (units) from blood samples.
T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Change on Analytic biomarkers (hemoglobin glycosylated).
Time Frame: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
This indicator assesses High Performance Liquid Chromatography - HPLC, (mmol/mol) from blood samples.
T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Change on Global distress
Time Frame: T0 - Screening; T2 - 4 weeks after baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Measured with Clinical Outcome Routine Evaluation - Outcome Measure, (CORE-OM) , a self-report measure of global distress (GD), comprising 34 items and four domains: subjective well-being, commonly experienced problems or symptoms, social/life functioning, and risk to self and others. The measure is scored on a 5-point scale ranging from 0 ('not at all') to 4 ('all the time'). The measure is suitable for use across a wide range of settings, it has been validated in different adult population with mental health problems, and it is sensitive to change.
T0 - Screening; T2 - 4 weeks after baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Change on quality of life
Time Frame: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Measured by World Health Organization Quality of Life - Bref - WHOQOL-Bref, a questionnaire suitable for epidemiological and clinical trials, which assesses quality of life as proposed by WHO. It is composed of 26 items distributed in one general facet and four domains (physical health, psychological, social relationships, and environment). Each item is rated on a 5-point Likert-type scale with higher scores being indicative of better self-reported quality of life (scoring procedures are available here: https://www.who.int/mental_health/media/en/76.pdf).
T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Change on fear of cancer recurrence
Time Frame: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Measured by a 7-item Fear of Cancer Recurrence - FCR-7 (PT version not yet available), a 7-item scale assessing fear of cancer recurrence in a 5-point Likert scale ranging from 1 (not at all) to 5 (all the time). It had demonstrated good psychometric properties. We will translate, adapt and validate this measure, following the usual procedures to adapt psychological measures.
T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Change on satisfaction perceived social support
Time Frame: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Satisfaction with Social Support Scale - SSSS, a 15-item scale assessing social support satisfaction discriminating four dimensions: satisfaction with friends/friendships, intimacy, satisfaction with family and social activities.
T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Change on emotional suppression
Time Frame: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Emotion Regulation Questionnaire - ERQ) , - Only the subscale of emotion suppression composed of 4-items will be used. The items are rated in 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).
T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Change on mindfulness abilities
Time Frame: T1 Baseline; T2 - 4 weeks after baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Measured by Mindfulness Five Facet Mindfulness Questionnaire - FFMQ, a 39 items questionnaire that assess mindfulness and self-awareness states in everyday life, which are organized in five different facets/subscales: observing, describing, acting with awareness, nonreactivity to inner experience, and nonjudging of inner experience. Each item is rated on a 5-point Likert-type scale ranging from 1 (never or very rarely true) and 5 (very often or always true).
T1 Baseline; T2 - 4 weeks after baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Change Interview
Time Frame: T3 - 8 weeks after baseline
This interview assesses the psychotherapeutic changes perceived by participants after psychological intervention. The interview questions explore the changes that a person has noticed since therapy began, what the person attributes these changes to, and helpful and unhelpful aspects of therapy, in a qualitative way.
T3 - 8 weeks after baseline
Change on smoking dependency
Time Frame: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Measured with Fageström Test for Nicotine Dependence - FTND. This instrument assesses nicotine dependency with 6 items (rated from 0 to 2 or 3). The total score range is 1-10, with higher values meaning higher nicotine dependency.
T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Change on physical activity
Time Frame: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Measured with International Physical Activity Questionnaire - Short Form - IPAQ-SF. This instrument assesses physical activity in 7 items, with higher scores meaning higher level of physical activity.
T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Change on sleep quality
Time Frame: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Measured with Basic Scale on Insomnia complaints and Quality of Sleep - BaSIQS - This is a self-report measure that focus on evaluating sleep quality, as well as problems to fall asleep and maintain sleep. It encompasses 7 items rated in a 5-point Likert-type and the total score ranges between 0 and 28, with highest values indicating poor sleep quality. Satisfactory psychometric properties were reported in the original study with Portuguese higher education students, but also on community and clinical samples
T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Change on posttraumatic growth
Time Frame: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Measured with Posttraumatic Growth Inventory - PTGI, which is a self-report questionnaire that evaluates positive psychological change in people experiencing traumatic events. It includes 21 items and each item is rated on a 6-point Likert-type scale ranging from 0 ("I did not experience this change as a result of my crisis") to 5 ("I experienced this change to a very great degree as a result of my crisis"). Total score ranges between 0 and 105, with higher values being indicative of a greater degree of posttraumatic growth.
T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto Portugues de Oncologia, Francisco Gentil, Porto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Coimbra
Linnaeus University
University of Oulu
European Commission
VTT Technical Research Centre, Finland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rui Henrique, PhD, Institute of Oncology of Porto, Portugal
  • Study Director: Carmen Jerónimo, PhD, Institute of Oncology of Porto, Portugal
  • Study Director: Eunice Silva, PhD, Institute of Oncology of Porto, Portugal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IPO/PI134b

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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