Impact of Group Psychological Interventions on Extracellular Vesicles in People Who Had Cancer (MindGAP-P)

Instituto Portugues de Oncologia, Francisco Gentil, Porto

Status: Unknown

Conditions: Cancer

Treatments: Behavioral: Mindfulness Based-Cognitive Therapy (MBCT); Other: Treatment as usual (no intervention); Behavioral: Emotion Focused Therapy Group for Cancer Recovery (EFT-CR)

Study type: Interventional

Funder types: Other

Identifiers

NCT04298398

IPO/PI134

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 3 patient groups

Mindfulness (MBCT)

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness Based-Cognitive Therapy (MBCT)

Emotion Focused Therapy (EFT-CR)

Experimental group

Description:

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

Treatment:

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

Control Group

Other group

Description:

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.

Treatment:

Other: Treatment as usual (no intervention)