Impact of Group Psychological Interventions on Extracellular Vesicles in People Who Had Cancer

NCT04298398 | Unknown

• 1 other identifier: IPO/PI134
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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. 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. 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.

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

Outcome Measures

Primary Outcomes (2)

• 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).

  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

  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)

  T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0

• Change on Prostate-specific antigen (PSA)

  T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0

• Change on Carcinoembryonic Antigen assays (CEA)

  T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0

• Change on Adrenocorticotropic Hormone (ACTH)

  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)

  T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0

Study Arms (3)

Mindfulness (MBCT)

EXPERIMENTAL

Group therapy based on Mindfulness Based-Cognitive Therapy (MBCT).

Behavioral: Mindfulness Based-Cognitive Therapy (MBCT)

Emotion Focused Therapy (EFT-CR)

EXPERIMENTAL

Group therapy based on Emotion Focused Therapy for Cancer Recovery (EFT-CR).

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.

Other: Treatment as usual (no intervention)

Interventions

Mindfulness Based-Cognitive Therapy (MBCT) BEHAVIORAL

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.

Mindfulness (MBCT)

Emotion Focused Therapy Group for Cancer Recovery (EFT-CR) BEHAVIORAL

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.

Emotion Focused Therapy (EFT-CR)

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Portugues de Oncologia, Francisco Gentil, Porto: lead
• Polytechnic Institute of Porto: collaborator
• VTT Technical Research Centre, Finland: collaborator
• University of Oulu: collaborator
• Linnaeus University: collaborator
• European Commission: collaborator

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Prostatic Neoplasms; Colorectal Neoplasms; Stress, Psychological; Anxiety Disorders; Depression

Interventions

Mindfulness-Based Cognitive Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Rui Henrique, PhD

  IPO-Porto

  STUDY CHAIR

• Carmen Jerónimo, PhD

  IPO-Porto

  STUDY DIRECTOR

• Eunice Silva, PhD

  IPO-Porto

  STUDY DIRECTOR

• Goreti Sales, PhD

  ISEP-Biomark (Polytecnic Institute of Porto)

  STUDY DIRECTOR

Central Study Contacts

Eunice Silva, PhD

CONTACT

00351 961761035; esilva@ipoporto.min-saude.pt

Carmen Jerónimo, PhD

CONTACT

00351 225084000; carmenjeronimo@ipoporto.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: only the investigator responsible for the eligibility assessment would be blind (in the recruitment, in order to assess eligibility to enter the study), before the randomization.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: March 6, 2020
• Study Start: September 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10