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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 108
- 主要终点
- Change on anxiety, depression and stress (Depression Anxiety Stress Scales, DASS21)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change on anxiety, depression and stress (Depression Anxiety Stress Scales, DASS21)
时间窗: 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
Change on Extracellular vesicles number by ultracentrifugation with sucrose cushion
时间窗: 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).
次要结局
- Change on Cancer antigen (CA 15-3)(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)
- Change on quality of life (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale, FACIT-SP)(T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0)
- Change Interview (Elliot, 1999)(T2-24 weeks after T0)
- Change on Prostate-specific antigen (PSA)(T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0)
- Change on Analytic biomarkers (Erythrocytes number)(T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0)
- Change on Analytic biomarkers (PCR number)(T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0)
- Change on satisfaction perceived social support (ESSS)(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)(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)(T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0)
- Change on physical activity (IPAQ,The International Physical Activity Questionnaire)(T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0)
- Change on quality of life (Functional Assessment of Cancer Therapy, FACT)(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)
- Change on Analytic biomarkers (telomerase activity)(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)(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)(T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0)
- Change on smoking dependency (Fagestrom Test)(T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0)
- Change on Analytic biomarkers (hemoglobin glycosylated (HPLC))(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)(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)(T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0)