CancerMindGAP-PNCT04298398
Impact of Group Psychological Interventions on Extracellular Vesicles in People Who Had Cancer
A study testing Mindfulness Based-Cognitive Therapy (MBCT) and Emotion Focused Therapy Group for Cancer Recovery (EFT-CR) in people with Cancer, run by Instituto Portugues de Oncologia, Francisco Gentil, Porto.
Trial summary
Background: There is some evidence demonstrating the effect of psychological interventions in improvements in health biological parameters. To best of our knowledge, no study had addressed the impact of any psychological intervention on extracellular vesicles. 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 Emotion Focused Therapy Group for Cancer Recovery (EFT-CR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to Sep 2021
- 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
- Men and women
- Aged 18 to 65
- Diagnosed with breast, prostate, or colorectal cancer
- Have been diagnosed with cancer stage I-III
- Have finished cancer treatments from 3 months to 2 years (it will be included ongoing hormonal therapies)
- Experiencing significant distress (5 or more) on the Distress Thermometer at baseline
Show all 9Show fewer
- Available to attend the intervention for the trial duration
- Sufficient functional ability to participate in intervention groups (ECOG)
- Ability to speak and write Portuguese and literacy to autonomous completion of questionnaires
Who cannot join
- Patients in treatments such as ongoing chemotherapy or radiotherapy, or trastuzumab therapy
- Patients with ostomy
- A diagnosis of a concurrent disorder of psychosis, substance abuse, bipolar disorder, or active suicidality
- Current use of antipsychotics
- Current use of anti-inflammatory medication (corticotherapy)
- Currently engaging in a mindfulness meditation practice or yoga, or having done so within the previous year
Show all 11Show fewer
- Being under any actual psychosocial or psychological treatment
- Participation in a MBCT program in the last five years
- Pregnancy or breast feeding
- A diagnosis of a concurrent autoimmune disorder
- Study Population Description: Participants will be recruited in the Portuguese Oncology Institute of Porto (Porto, Portugal), which is a reference public hospital in the north of the country offering cancer treatments.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Mindfulness-Based Cognitive Therapy and Emotion Focused Therapy Group for Cancer Recovery Interventions on Extracellular Vesicles and Psychological Distress in People Who Had Breast, Colorectal or Prostate Cancer: A Preliminary Parallel Randomized Controlled Trial
Background: There is some evidence demonstrating the effect of psychological interventions in improvements in health biological parameters. To best of our knowledge, no study had addressed the impact of any psychological intervention on extracellular vesicles. In addition, Mindfulness-Based Cognitive Therapy (MBCT) and Emotion Focused Therapy for Cancer Recovery (EFT-CR) in the group have never been explored regarding extracellular vesicles and the effectiveness of these was not compared yet.
Objectives:
Read more
- To explore and compare the effect of MBCT and EFT-CR on biological parameters and psychological variables in distressed people who have had breast, prostate and colorectal cancer;
- In addition, we will explore the acceptability through recruitment and retention rates of MBCT and EFT-CR in group and evaluate whether these interventions are appropriate for a larger clinical trial.
Methods: The design of this study is a parallel randomized controlled trial. Participants will be randomized into MBCT, EFT-CR or usual care. Outcome measures will be assessed before, at the end of the intervention (8 weeks) and follow-ups (24 and 52 weeks from the baseline moment).
Hypotheses: The researchers expected that both interventions will have an effect on extracellular vesicles and other study biomarkers as well as improvements in psychological outcomes, compared to treatment as usual (TAU) group. Regarding the comparative effectiveness, we did not have evidence to hypothesize which one of the interventions will be superior in both biological (extracellular vesicles) and psychological outcomes.
Contribution for practice: The results of this preliminary study would permit to know if there are benefits of these psychological interventions on changes in extracellular vesicles and on psychological outcomes related to health. In addition, this study will permit to determine the acceptability of conducting a larger randomized controlled trial.
- Conditions
- Cancer
- Being tested
- Mindfulness Based-Cognitive Therapy (MBCT), Emotion Focused Therapy Group for Cancer Recovery (EFT-CR), Treatment as usual (no intervention)
- Keywords
- Breast cancer, Prostate cancer, Colorectal cancer, Psychological stress, Anxiety, Depression, Emotion Focused Therapy, Distress, Extracellular vesicles, Exosomes, Biomarkers, Inflammatory response genes, Group interventions, Mindfulness, Mindfulness Based Cognitive Therapy
- Medical subject headings
- Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms, Stress, Psychological, 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
MBCT is a program developed by Zindel Segal, Mark Williams and John Teasdale. During MBCT patients learn to decenter their negative thoughts and feelings, allowing the mind to move from an automatic thought pattern to conscious emotional processing. Mindfulness practices included in this program are breath awareness, body scan, sitting and walking meditation, and mindful yoga. The intervention will have the following structure: 8 weekly face-to-face meetings of 2 hours in a group format, daily home-based practice of learned skills, 4 hours of retreat/intensive group work after the fifth week, 6 months of home practice, 4 monthly consolidation face-to-face sessions.
Emotion Focused Therapy Group for Cancer Recovery (EFT-CR)Behavioural
EFT-CR is an evidence-based approach to psychotherapy, which combines aspects of person-centered, gestalt and existential therapies with contemporary emotion theory and dialectical constructivism (Elliott et al, 2004, Rice \& Greenberg, 1984). On EFT-CR, therapist follows the client experience and guides the process, proposing therapeutic tasks when specific client behaviors occur. EFT-CR uses a set of emotion change principles which guide a process of emotional deepening process, from undifferentiated distress to secondary reactive emotions to primary maladaptive emotions to core pain and thence to primary adaptive emotions and emotional transformation (Elliott \& Greenberg 2016). The intervention will have the following structure: 8 weekly face-to-face meetings of 2 hours in a group format, daily home-based practice of learned skills, 4 hours of retreat/intensive group work after the fifth week, 6 months of home practice, 4 monthly consolidation face-to-face sessions.
Treatment as usual (no intervention)Other
Treatment as Usual is the condition in which participants will follow the usual institutional intervention protocol for medical follow-up and identification, referral and intervention for people identified with significant distress difficulties.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness (MBCT) | Experimental | Group therapy based on Mindfulness Based-Cognitive Therapy (MBCT). Receives: Behavioral: Mindfulness Based-Cognitive Therapy (MBCT) |
| Emotion Focused Therapy (EFT-CR) | Experimental | Group therapy based on Emotion Focused Therapy for Cancer Recovery (EFT-CR). Receives: Behavioral: Emotion Focused Therapy Group for Cancer Recovery (EFT-CR) |
| Control Group | Other | Treatment as Usual is the condition in which participants will follow the usual institutional intervention protocol for medical follow-up and identification, referral and intervention for people identified with significant distress difficulties. Receives: Other: Treatment as usual (no intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on Extracellular vesicles number by ultracentrifugation with sucrose cushion
The collected extracellular vesicles will be quantified by Nanoparticle tracking analysis (Nanosight Ltd.), and data will be measured in particles per milliliter (mL). NTA measures Brownian movements on a particle-by-particle basis tracking movements by image analysis. Additionally, miR21-5p - a brain related microRNA - will be measured to ascertain for the extracellular vesicle's origin. The latter will be achieved by isothermal DNA amplification method, and data will be measured by luminescence (in RLU - relative light unit).
Measured: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
Change on anxiety, depression and stress (Depression Anxiety Stress Scales, DASS21)
This self-report instrument assess the depressive, anxiety and stress symptoms in a 4-points likert scale, from 0 to 3, with higher values representing higher depression, anxiety and stress symptoms
Measured: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
Secondary outcomes (21)
Change on Cancer antigen (CA 15-3)
This indicator assess CA 15-3 (units/mL) using an immunoassay analyzer
Measured: T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0
Change on Prostate-specific antigen (PSA)
This indicator assess PSA (ng/mL) using an immunoassay analyzer
Measured: T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0
Change on Carcinoembryonic Antigen assays (CEA)
This indicator assess CEA (ng/mL) using an immunoassay analyzer
Measured: T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0
Change on Adrenocorticotropic Hormone (ACTH)
This indicator assess ACTH (pg/mL) using an immunoassay analyzer
Measured: T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0
Transcript inflammatory response genes (IL-1, IL-6, IL-8, IL-10, IFNγ and TNF)
These indicators assess inflammatory response genes in plasma by Quantitative RT-PCR assays of the same individuals using TaqMan™ Gene Expression Assays
Measured: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
Change on Analytic biomarkers (Erythrocytes number)
This indicator assess erythrocytes number (million/mm3) from blood samples(Sysmex XN)
Measured: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
Change on Analytic biomarkers (PCR number)
This indicator assess PCR (mg/L) from blood samples
Measured: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
Change on Analytic biomarkers (telomerase activity)
This indicator assess telomerase activity (units) from blood samples
Measured: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
Change on Analytic biomarkers (hemoglobin glycosylated (HPLC))
This indicator assess HPLC (mmol/mol) from blood samples
Measured: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
Change on Global distress (Clinical Outcome Routine Evaluation - Outcome Measure, CORE-OM)
This self-report measure assesses global distress in four domains: subjective well-being, symptoms, social/life functioning, risk to self and others, rated in 5-points likert scale from never to always. Higher scores meaning higher psychological suffering
Measured: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
Change on quality of life (Functional Assessment of Cancer Therapy, FACT)
These self-report instrument assess perceived quality of life related to the cancer, in a 5-points likert scale, from 0 to 4, with higher value indicated higher quality of life
Measured: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
Change on quality of life (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale, FACIT-SP)
These self-report instruments assess perceived spiritually related to the cancer in a 5-points likert scale, from 0 to 4, with higher value indicated higher well-being
Measured: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
Change on fear of cancer recurrence (Fear of Cancer Recurrence, FCR-7)
This self-report instrument assess the fear of cancer recurrence, rated in a 5-points likert scale, with higher values indicated higher fear of recurrence
Measured: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
Change on satisfaction perceived social support (ESSS)
This self-report instrument assess the perceived level of social support, rated in a 5-points likert scale, with higher values meaning higher social support
Measured: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
Change on emotional regulation processes (Emotion Regulation Questionnaire, ERQ, emotion suppression subscale)
This self-report measure assess the emotion regulation processes rated in a 7-points likert scale, with higher values representing higher emotional suppression
Measured: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
Change on impact of events (Impact of Event Scale - Revised, IES-R)
This self-report measure assess the impact of significant events, rated in a 5-points likert scale, with higher scores meaning higher negative impact of the event
Measured: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
Change on Mindfulness Attention and Awareness (Mindfulness Attention and Awareness Scale, MAAS)
This self-report measure assess the mindfulness and awareness skills, rated in a 6-points likert scale with higher scores indicating higher attention and awareness
Measured: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
Change on self-compassion skills (Self-Compassion Scale - Short Form, SHORT FORM)
This self-report measure assess the self-compassion skills, rated in 5-points likert scale, with higher scores indicating higher self-compassion
Measured: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
Change Interview (Elliot, 1999)
This interview assesses the psycho-therapeutic 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. In addition, the participants identified therapeutic changes as result of the therapy and are asked to rate these changes in three scales: expected change (1: change totally expected; 5: totally unexpected); change without therapy (1: the change would not have happened; 5: change would happen for sure); and the value of the change (1: nothing important; 5: extremely important).
Measured: T2-24 weeks after T0
Change on smoking dependency (Fagestrom Test)
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: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
Change on physical activity (IPAQ,The International Physical Activity Questionnaire)
This instrument assesses physical activity in 7 items, with higher scores meaning higher level of physical activity
Measured: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start1 Sep 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Portugues de Oncologia, Francisco Gentil, Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Polytechnic Institute of Porto, VTT Technical Research Centre, Finland, University of Oulu, Linnaeus University, European Commission
- Responsible party
- Sponsor
- Investigators
- Rui Henrique, PhD, Study chair, IPO-PortoCarmen Jerónimo, PhD, Study director, IPO-PortoEunice Silva, PhD, Study director, IPO-PortoGoreti Sales, PhD, Study director, ISEP-Biomark (Polytecnic Institute of Porto)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298398
- Sponsor's protocol ID
- IPO/PI134
- Acronym
- MindGAP-P
- Status last verified
- Oct 2020
- First submitted
- 13 Feb 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mindfulness-Based Cognitive Therapy and Emotion Focused Therapy Group for Cancer Recovery Interventions on Extracellular Vesicles and Psychological Distress in People Who Had Breast, Colorectal or Prostate Cancer: A Preliminary Parallel Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04298398
- Acronym / sponsor ID
- MindGAP-P / IPO/PI134
- Conditions
- Cancer
- Keywords
- Breast cancer, Prostate cancer, Colorectal cancer, Psychological stress, Anxiety, Depression, Emotion Focused Therapy, Distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Instituto Portugues de Oncologia, Francisco Gentil, PortoUniversity, hospital or other
- Collaborators
- Polytechnic Institute of Porto, VTT Technical Research Centre, Finland, University of Oulu, Linnaeus University, European Commission
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 6 Mar 2020 (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.
Background: There is some evidence demonstrating the effect of psychological interventions in improvements in health biological parameters. To best of our knowledge, no study had addressed the impact of any psychological intervention on extracellular vesicles. In addition, Mindfulness-Based Cognitive Therapy (MBCT) and Emotion Focused Therapy for Cancer Recovery (EFT-CR) in the group have never been explored regarding extracellular vesicles and the effectiveness of these was not compared yet.
Objectives:
- To explore and compare the effect of MBCT and EFT-CR on biological parameters and psychological variables in distressed people who have had breast, prostate and colorectal cancer;
- In addition, we will explore the acceptability through recruitment and retention rates of MBCT and EFT-CR in group and evaluate whether these interventions are appropriate for a larger clinical trial.
Methods: The design of this study is a parallel randomized controlled trial. Participants will be randomized into MBCT, EFT-CR or usual care. Outcome measures will be assessed before, at the end of the intervention (8 weeks) and follow-ups (24 and 52 weeks from the baseline moment).
Hypotheses: The researchers expected that both interventions will have an effect on extracellular vesicles and other study biomarkers as well as improvements in psychological outcomes, compared to treatment as usual (TAU) group. Regarding the comparative effectiveness, we did not have evidence to hypothesize which one of the interventions will be superior in both biological (extracellular vesicles) and psychological outcomes.
Contribution for practice: The results of this preliminary study would permit to know if there are benefits of these psychological interventions on changes in extracellular vesicles and on psychological outcomes related to health. In addition, this study will permit to determine the acceptability of conducting a larger randomized controlled trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness (MBCT) | Experimental | Behavioral: Mindfulness Based-Cognitive Therapy (MBCT)Group therapy based on Mindfulness Based-Cognitive Therapy (MBCT). |
| Emotion Focused Therapy (EFT-CR) | Experimental | Behavioral: Emotion Focused Therapy Group for Cancer Recovery (EFT-CR)Group therapy based on Emotion Focused Therapy for Cancer Recovery (EFT-CR). |
| Control Group | Other | Other: Treatment as usual (no intervention)Treatment as Usual is the condition in which participants will follow the usual institutional intervention protocol for medical follow-up and identification, referral and intervention for people identified with significant distress difficulties. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women
- Aged 18 to 65
- Diagnosed with breast, prostate, or colorectal cancer
- Have been diagnosed with cancer stage I-III
- Have finished cancer treatments from 3 months to 2 years (it will be included ongoing hormonal therapies)
Key exclusion criteria (11 listed)
- Patients in treatments such as ongoing chemotherapy or radiotherapy, or trastuzumab therapy
- Patients with ostomy
- A diagnosis of a concurrent disorder of psychosis, substance abuse, bipolar disorder, or active suicidality
- Current use of antipsychotics
- Current use of anti-inflammatory medication (corticotherapy)
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)MBCT is a program developed by Zindel Segal, Mark Williams and John Teasdale. During MBCT patients learn to decenter their negative thoughts and feelings, allowing the mind to move from an automatic thought pattern to conscious emotional processing. Mindfulness practices included in this program are breath awareness, body scan, sitting and walking meditation, and mindful yoga. The intervention will have the following structure: 8 weekly face-to-face meetings of 2 hours in a group format, daily home-based practice of learned skills, 4 hours of retreat/intensive group work after the fifth week, 6 months of home practice, 4 monthly consolidation face-to-face sessions. | Behavioural | Mindfulness (MBCT) |
| Emotion Focused Therapy Group for Cancer Recovery (EFT-CR)EFT-CR is an evidence-based approach to psychotherapy, which combines aspects of person-centered, gestalt and existential therapies with contemporary emotion theory and dialectical constructivism (Elliott et al, 2004, Rice \& Greenberg, 1984). On EFT-CR, therapist follows the client experience and guides the process, proposing therapeutic tasks when specific client behaviors occur. EFT-CR uses a set of emotion change principles which guide a process of emotional deepening process, from undifferentiated distress to secondary reactive emotions to primary maladaptive emotions to core pain and thence to primary adaptive emotions and emotional transformation (Elliott \& Greenberg 2016). The intervention will have the following structure: 8 weekly face-to-face meetings of 2 hours in a group format, daily home-based practice of learned skills, 4 hours of retreat/intensive group work after the fifth week, 6 months of home practice, 4 monthly consolidation face-to-face sessions. | Behavioural | Emotion Focused Therapy (EFT-CR) |
| Treatment as usual (no intervention)Treatment as Usual is the condition in which participants will follow the usual institutional intervention protocol for medical follow-up and identification, referral and intervention for people identified with significant distress difficulties. | Other | Control Group |
Primary outcome
Change on Extracellular vesicles number by ultracentrifugation with sucrose cushion
Time frame: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
The collected extracellular vesicles will be quantified by Nanoparticle tracking analysis (Nanosight Ltd.), and data will be measured in particles per milliliter (mL). NTA measures Brownian movements on a particle-by-particle basis tracking movements by image analysis. Additionally, miR21-5p - a brain related microRNA - will be measured to ascertain for the extracellular vesicle's origin. The latter will be achieved by isothermal DNA amplification method, and data will be measured by luminescence (in RLU - relative light unit).
Change on anxiety, depression and stress (Depression Anxiety Stress Scales, DASS21)
Time frame: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
This self-report instrument assess the depressive, anxiety and stress symptoms in a 4-points likert scale, from 0 to 3, with higher values representing higher depression, anxiety and stress symptoms
21 secondary outcomes
Change on Cancer antigen (CA 15-3)
Time frame: T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0
Change on Prostate-specific antigen (PSA)
Time frame: T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0
Change on Carcinoembryonic Antigen assays (CEA)
Time frame: T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0
Change on Adrenocorticotropic Hormone (ACTH)
Time frame: T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0
Transcript inflammatory response genes (IL-1, IL-6, IL-8, IL-10, IFNγ and TNF)
Time frame: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
Change on Analytic biomarkers (Erythrocytes number)
Time frame: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
Change on Analytic biomarkers (PCR number)
Time frame: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
Change on Analytic biomarkers (telomerase activity)
Time frame: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
Change on Analytic biomarkers (hemoglobin glycosylated (HPLC))
Time frame: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
Change on Global distress (Clinical Outcome Routine Evaluation - Outcome Measure, CORE-OM)
Time frame: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
Change on quality of life (Functional Assessment of Cancer Therapy, FACT)
Time frame: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
Change on quality of life (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale, FACIT-SP)
Time frame: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
Change on fear of cancer recurrence (Fear of Cancer Recurrence, FCR-7)
Time frame: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
Change on satisfaction perceived social support (ESSS)
Time frame: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
Change on emotional regulation processes (Emotion Regulation Questionnaire, ERQ, emotion suppression subscale)
Time frame: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
Change on impact of events (Impact of Event Scale - Revised, IES-R)
Time frame: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
Change on Mindfulness Attention and Awareness (Mindfulness Attention and Awareness Scale, MAAS)
Time frame: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
Change on self-compassion skills (Self-Compassion Scale - Short Form, SHORT FORM)
Time frame: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
Change Interview (Elliot, 1999)
Time frame: T2-24 weeks after T0
Change on smoking dependency (Fagestrom Test)
Time frame: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
Change on physical activity (IPAQ,The International Physical Activity Questionnaire)
Time frame: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
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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 chair
IPO-Porto
Carmen Jerónimo, PhD study director
IPO-Porto
Eunice Silva, PhD study director
IPO-Porto
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based-Cognitive Therapy (MBCT) and Emotion Focused Therapy Group for Cancer Recovery (EFT-CR) in people with Cancer, run by Instituto Portugues de Oncologia, Francisco Gentil, Porto.
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 9 inclusion and 11 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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 ext. 7808, 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 number by ultracentrifugation with sucrose cushion (time frame: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0). 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?
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 22 Oct 2020.