The Modulatory Role of Internet-supported Mindfulness-based Cognitive Therapy on Extracellular Vesicles and Psychological Distress in People Who Have Had Cancer: A Study Protocol for a Two-armed Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Change on Distress
研究概览
简要总结
Mindfulness-based interventions (MBIs), such as mindfulness-based stress reduction (MBSR), mindfulness-based cognitive therapy (MBCT), mindfulness-based cancer recovery (MBCR), have been showing promising results in different health-related and psychosocial outcomes in the context of cancer. More recently, the possibility of delivering MBIs using technological tools and resources, such as internet and applications, has been receiving much attention, also accompanied by promising findings. However, few randomized controlled studies have been conducted and published to date. Moreover, few studies have addressed the long-term stability and trajectory of gains across time. Also, even though prior evidence had suggested that face-to-face MBIs might modulate several biological markers (e.g., pro-inflammatory gene expression and inflammatory signaling; telomere length), as far as we know, no previous study addressed the impact of online MBIs on biological indices, especially on extracellular vesicles (EVs).
As primary objective, this study aims to investigate the effects of an internet-based MBCT intervention (vs. Treatment as Usual - TAU) on EVs (objective measure), as well as on psychological distress (subjective measure), considering a sample of distressed people with history of breast, prostate, and colorectal cancer.
As secondary objective, this study aims to investigate the effects of this same intervention on psychosocial outcomes, including quality of life, fear of cancer recurrence, emotion suppression, mindfulness, sleep quality, posttraumatic growth, health-related behaviours (physical activity; smoking habits), and perceived social support. The biological secondary outcomes studied will be: inflammatory response genes interleukins (ILs, IL-1, IL-6, IL-8, IL-10), interferon gamma (IFN-γ), tumour necrosis factor (TNF), and c-reactive protein (CRP); telomerase activity; antigens related to cancer (cancer antigen - CA 15-3; prostate-specific antigen - PSA; carcinoembryonic antigen - CEA); other health-related markers (adrenocorticotropic hormone - ACTH; erythrocytes number; hemoglobin glycosylated).
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
At baseline, everyone (participants, study coordinator, mindfulness instructor(s), research assistant, and statistician) will be blinded to conditions as it is expected to occur before randomization. Once participants are randomized, the study coordinator will inform them of the group assignments, and all of them will become unblinded to the conditions. Due to the specificities of this type of study and intervention, it is not possible to guarantee the blinding of personnel and participants.
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
- •Diagnosis of breast, prostate, or colorectal cancer;
- •Cancer stage I - III;
- •Primary cancer treatments completed between 3 months and 5 years (participants with ongoing adjuvant hormonal therapies will be included);
- •Age between 18 and 65 years;
- •Experiencing significant distress on the Distress Thermometer (DT ≥ 4)
- •Willingness to accept randomization to one of the two study conditions and to attend the study for its duration;
- •Ability to speak, read, and write in Portuguese and literacy to complete autonomously the self-report measures;
- •Sufficient digital literacy with access to a device (e.g., smartphone; tablet; computer) with camera, microphone, and internet.
排除标准
- •Concurrent diagnosis of severe psychiatric condition(s) (e.g., psychosis; substance abuse; bipolar disorder; suicidal ideation);
- •Concurrent diagnosis of autoimmune disorder;
- •Current use of antipsychotics;
- •Current use of anti-inflammatory medication (corticotherapy);
- •Undergoing trastuzumab therapy;
- •Participation in a structured mindfulness program (e.g., MBCT; MBSR; Mindfulness-Based Cancer Recovery - MBCR) program in the past five years;
- •Currently attending psychological consultation;
- •Being pregnant or breastfeeding.
结局指标
主要结局
Change on Distress
时间窗: T1- before intervention; T2 - 4 weeks after baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Measured with Depression Anxiety Stress Scales-21 - DASS-21, a self-report and public domain questionnaire that evaluates negative affective states. It is composed of 21 items, 7 focused on depression, 7 on anxiety, and 7 on stress. Each item is rated on a 4-point Likert-type scale, wherein in 0 represents "did not apply to me at all" and 3 represents "applied to me very much or most of the time". The score for each subscale ranges between 0 and 21. In the current study, a total score will be computed by summing all items, with higher scores being indicative of higher self-reported psychological distress.
Change on Extracellular Vesicles
时间窗: T1 - before intervention; 8 weeks after T1; 24 weeks after T1
Isolated by ultracentrifugation with sucrose cushion. The collected EVs will be quantified by Nanoparticle tracking analysis (Nanosight Ltd.), and data will be measured in particles per milliliter (mL).
次要结局
- Change on Cancer antigen 15-3 (CA 15-3)(T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline)
- Transcript inflammatory response genes (Interleukins, ILs, IL-1, IL-6, IL-8, IL-10, IFNγ and TNF).(T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline)
- Change on Analytic biomarkers (hemoglobin glycosylated).(T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline)
- Change on satisfaction perceived social support(T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline)
- Change on emotional suppression(T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline)
- Change Interview(T3 - 8 weeks after baseline)
- Change on posttraumatic growth(T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline)
- Change on Prostate-specific antigen (PSA)(T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline)
- Change on Carcinoembryonic Antigen (CEA).(T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline)
- Change on Adrenocorticotropic Hormone (ACTH).(T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline)
- Change on Analytic biomarkers (Erythrocyte number).(T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline)
- Change on Analytic biomarkers (PCR number).(T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline)
- Change on smoking dependency(T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline)
- Change on sleep quality(T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline)
- Change on Analytic biomarkers (telomerase activity).(T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline)
- Change on Global distress(T0 - Screening; T2 - 4 weeks after baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline)
- Change on quality of life(T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline)
- Change on fear of cancer recurrence(T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline)
- Change on mindfulness abilities(T1 Baseline; T2 - 4 weeks after baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline)
- Change on physical activity(T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline)