Clinical trial NCT04298398: Impact of Group Psychological Interventions on Extracellular Vesicles in People Who Had Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
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
Lead sponsor: Instituto Portugues de Oncologia, Francisco Gentil, Porto
Sponsor class: OTHER
Collaborators: name: Polytechnic Institute of Porto
name: VTT Technical Research Centre, Finland
name: University of Oulu
name: Linnaeus University
name: European Commission
First posted: 2020-03-06
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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:

1. 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;
2. 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Change on Extracellular vesicles number by ultracentrifugation with sucrose cushion
timeFrame: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
measure: Change on anxiety, depression and stress (Depression Anxiety Stress Scales, DASS21)
timeFrame: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
Secondary outcomes:
measure: Change on Cancer antigen (CA 15-3)
timeFrame: T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0
measure: Change on Prostate-specific antigen (PSA)
timeFrame: T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0
measure: Change on Carcinoembryonic Antigen assays (CEA)
timeFrame: T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0
measure: Change on Adrenocorticotropic Hormone (ACTH)
timeFrame: T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0
measure: Transcript inflammatory response genes (IL-1, IL-6, IL-8, IL-10, IFNγ and TNF)
timeFrame: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
measure: Change on Analytic biomarkers (Erythrocytes number)
timeFrame: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
measure: Change on Analytic biomarkers (PCR number)
timeFrame: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
measure: Change on Analytic biomarkers (telomerase activity)
timeFrame: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
measure: Change on Analytic biomarkers (hemoglobin glycosylated (HPLC))
timeFrame: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
measure: Change on Global distress (Clinical Outcome Routine Evaluation - Outcome Measure, CORE-OM)
timeFrame: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
measure: Change on quality of life (Functional Assessment of Cancer Therapy, FACT)
timeFrame: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
measure: Change on quality of life (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale, FACIT-SP)
timeFrame: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
measure: Change on fear of cancer recurrence (Fear of Cancer Recurrence, FCR-7)
timeFrame: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
measure: Change on satisfaction perceived social support (ESSS)
timeFrame: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
measure: Change on emotional regulation processes (Emotion Regulation Questionnaire, ERQ, emotion suppression subscale)
timeFrame: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
measure: Change on impact of events (Impact of Event Scale - Revised, IES-R)
timeFrame: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
measure: Change on Mindfulness Attention and Awareness (Mindfulness Attention and Awareness Scale, MAAS)
timeFrame: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
measure: Change on self-compassion skills (Self-Compassion Scale - Short Form, SHORT FORM)
timeFrame: T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0
measure: Change Interview (Elliot, 1999)
timeFrame: T2-24 weeks after T0
measure: Change on smoking dependency (Fagestrom Test)
timeFrame: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
measure: Change on physical activity (IPAQ,The International Physical Activity Questionnaire)
timeFrame: T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0
Other outcomes:
Locations:
Study officials:
affiliation: IPO-Porto
name: Rui Henrique, PhD
role: STUDY_CHAIR
affiliation: IPO-Porto
name: Carmen Jerónimo, PhD
role: STUDY_DIRECTOR
affiliation: IPO-Porto
name: Eunice Silva, PhD
role: STUDY_DIRECTOR
affiliation: ISEP-Biomark (Polytecnic Institute of Porto)
name: Goreti Sales, PhD
role: STUDY_DIRECTOR
References: