CancerMINDGAPNCT04727593
The Modulatory Role of Internet MBCT on Extracellular Vesicles and Distress in Cancer Patients - Study Protocol
A study testing Mindfulness Based Cognitive Therapy (MBCT) and Treatment as Usual in people with Cancer, run by Instituto Portugues de Oncologia, Francisco Gentil, Porto at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cancer
- What is being tested?
- Mindfulness Based Cognitive Therapy (MBCT) and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 sitePortugal
- Study dates
- 3 Sep 2021to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072
Eunice D Silva, PhD, 00351961761035, esilva@ipoporto.min-saude.pt
Carmen Jerónimo, PhD, 00351225084000 ext. 1952, carmenjeronimo@ipoporto.min-saude.pt
About this study
Official title: 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).
- Conditions
- Cancer
- Being tested
- Mindfulness Based Cognitive Therapy (MBCT), Treatment as Usual
- Keywords
- Cancer, Internet, Extracellular vesicles, Distress, Mindfulness, Mindfulness Based Cognitive Therapy, Anxiety, Depression, Biomarkers, eHealth, Telehealth
- Medical subject headings
- Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive Therapy (MBCT)Behavioural
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 UsualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Cognitive Therapy (MBCT) | Experimental | Group intervention on Mindfulness-Based Cognitive Therapy classic program plus 4 monthly consolidation sessions of 90 minutes each. Receives: Behavioral: Mindfulness Based Cognitive Therapy (MBCT) |
| Treatment as Usual (TAU) | Other | TAU will be the control condition. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on Extracellular Vesicles
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).
Measured: T1 - before intervention; 8 weeks after T1; 24 weeks after T1
Change on Distress
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.
Measured: T1- before intervention; T2 - 4 weeks after baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Secondary outcomes (20)
Change on Cancer antigen 15-3 (CA 15-3)
Using an immunoassay analyser (units/mL).
Measured: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Change on Prostate-specific antigen (PSA)
Using an immunoassay analyser (ng/mL).
Measured: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Change on Carcinoembryonic Antigen (CEA).
Using an immunoassay analyser (ng/mL).
Measured: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Change on Adrenocorticotropic Hormone (ACTH).
Using an immunoassay analyser (pg/mL).
Measured: 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).
Assessed by quantitative RT-PCR (TaqMan™ Gene Expression Assays).
Measured: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Change on Analytic biomarkers (Erythrocyte number).
This indicator assesses erythrocytes number (million/mm3) from blood samples (Sysmex XN).
Measured: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Change on Analytic biomarkers (PCR number).
This indicator assesses PCR (mg/L) from blood samples.
Measured: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Change on Analytic biomarkers (telomerase activity).
This indicator assesses telomerase activity (units) from blood samples.
Measured: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Change on Analytic biomarkers (hemoglobin glycosylated).
This indicator assesses High Performance Liquid Chromatography - HPLC, (mmol/mol) from blood samples.
Measured: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
Change on Global distress
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.
Measured: 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
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).
Measured: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Change on fear of cancer recurrence
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.
Measured: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Change on satisfaction perceived social support
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.
Measured: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Change on emotional suppression
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).
Measured: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Change on mindfulness abilities
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).
Measured: T1 Baseline; T2 - 4 weeks after baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Change Interview
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.
Measured: T3 - 8 weeks after baseline
Change on smoking dependency
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.
Measured: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Change on physical activity
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.
Measured: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Change on sleep quality
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
Measured: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Change on posttraumatic growth
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.
Measured: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start3 Sep 2021
- Primary completion1 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Portugues de Oncologia, Francisco Gentil, Porto
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, University of Coimbra, VTT Technical Research Centre, Finland, University of Oulu, Linnaeus University
- Responsible party
- Sponsor
- Investigators
- Rui Henrique, PhD, Study director, Institute of Oncology of Porto, PortugalCarmen Jerónimo, PhD, Study director, Institute of Oncology of Porto, PortugalEunice Silva, PhD, Study director, Institute of Oncology of Porto, Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727593
- Sponsor's protocol ID
- IPO/PI134b
- Acronym
- MINDGAP
- Status last verified
- Sep 2023
- First submitted
- 18 Jan 2021
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pereira DR, Silva ER, Carvalho-Maia C, Monteiro-Reis S, Lourenco C, Calisto R, Teixeira RJ, Carlson LE, Bart G, Vainio SJ, Sales MGF, Jeronimo C, Henrique R. 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. Trials. 2022 Feb 5;23(1):118. doi: 10.1186/s13063-022-06045-x.
PubMed 35123569
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04727593
- Acronym / sponsor ID
- MINDGAP / IPO/PI134b
- Conditions
- Cancer
- Keywords
- Cancer, Internet, Extracellular vesicles, Distress, Mindfulness, Mindfulness Based Cognitive Therapy, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Instituto Portugues de Oncologia, Francisco Gentil, PortoUniversity, hospital or other
- Collaborators
- European Commission, University of Coimbra, VTT Technical Research Centre, Finland, University of Oulu, Linnaeus University
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Cognitive Therapy (MBCT) | Experimental | Behavioral: Mindfulness Based Cognitive Therapy (MBCT)Group intervention on Mindfulness-Based Cognitive Therapy classic program plus 4 monthly consolidation sessions of 90 minutes each. |
| Treatment as Usual (TAU) | Other | Other: Treatment as UsualTAU will be the control condition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mindfulness Based Cognitive Therapy (MBCT) |
| Treatment as UsualIn 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. | Other | Treatment as Usual (TAU) |
Primary outcome
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).
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.
20 secondary outcomes
Change on Cancer antigen 15-3 (CA 15-3)
Time frame: 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
Change on Carcinoembryonic Antigen (CEA).
Time frame: 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
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
Change on Analytic biomarkers (Erythrocyte number).
Time frame: 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
Change on Analytic biomarkers (telomerase activity).
Time frame: 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
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
Change on quality of life
Time frame: 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
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
Change on emotional suppression
Time frame: 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
Change Interview
Time frame: 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
Change on physical activity
Time frame: 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
Change on posttraumatic growth
Time frame: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Derived from this study: PubMed 35123569Pereira DR, Silva ER, Carvalho-Maia C, Monteiro-Reis S, Lourenco C, Calisto R, Teixeira RJ, Carlson LE, Bart G, Vainio SJ, Sales MGF, Jeronimo C, Henrique R. 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. Trials. 2022 Feb 5;23(1):118. doi: 10.1186/s13063-022-06045-x.
- MindGAP project websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rui Henrique, PhD study director
Institute of Oncology of Porto, Portugal
Carmen Jerónimo, PhD study director
Institute of Oncology of Porto, Portugal
Eunice Silva, PhD study director
Institute of Oncology of Porto, Portugal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Cognitive Therapy (MBCT) and Treatment as Usual in people with Cancer, run by Instituto Portugues de Oncologia, Francisco Gentil, Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eunice Silva, PhD (00351 961761035, esilva@ipoporto.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on Extracellular Vesicles (time frame: T1 - before intervention; 8 weeks after T1; 24 weeks after T1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04727593, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.