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

NCT ID: NCT04298398

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2021-09-30

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mindfulness (MBCT)

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

Group Type: EXPERIMENTAL

Mindfulness Based-Cognitive Therapy (MBCT)

Intervention Type: 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.

Emotion Focused Therapy (EFT-CR)

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Control Group

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.

Group Type: OTHER

Treatment as usual (no intervention)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Polytechnic Institute of Porto

OTHER

Sponsor Role: collaborator

VTT Technical Research Centre, Finland

OTHER

Sponsor Role: collaborator

University of Oulu

OTHER

Sponsor Role: collaborator

Linnaeus University

OTHER

Sponsor Role: collaborator

European Commission

OTHER

Sponsor Role: collaborator

Instituto Portugues de Oncologia, Francisco Gentil, Porto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rui Henrique, PhD

Role: STUDY_CHAIR

IPO-Porto

Carmen Jerónimo, PhD

Role: STUDY_DIRECTOR

IPO-Porto

Eunice Silva, PhD

Role: STUDY_DIRECTOR

IPO-Porto

Goreti Sales, PhD

Role: STUDY_DIRECTOR

ISEP-Biomark (Polytecnic Institute of Porto)

Central Contacts

Eunice Silva, PhD

Role: CONTACT

esilva@ipoporto.min-saude.pt

00351 961761035 ext. 7808

Carmen Jerónimo, PhD

Role: CONTACT

carmenjeronimo@ipoporto.min-saude.pt

00351 225084000 ext. 1952

Other Identifiers

IPO/PI134

Identifier Type: -

Identifier Source: org_study_id