The MATCH Study: Mindfulness And Tai Chi for Cancer Health

Titre officiel

The MATCH Study: Mindfulness And Tai Chi for Cancer Health A Preference-Based Multi-Site Randomized Comparative Effectiveness Trial (CET) of Mindfulness-Based Cancer Recovery (MBCR) vs. Tai Chi/Qigong (TCQ) in Cancer Survivors

Sommaire:

Contexte : Alors que de plus en plus de personnes survivent au cancer, l’importance de la recherche sur les interventions efficaces en vue d’améliorer la qualité de vie chez les survivants ne cesse de croître. Deux interventions sont appuyées par des données probantes substantielles, soit le programme MBCR (Mindfulness-Based Cancer Recovery) axé sur la méditation pleine conscience et la pratique du tai-chi et du qi gong (TCQ). Toutefois, ces interventions n’ont jamais fait l’objet d’une comparaison directe.

Objectifs : 1) Comparer le programme MBCR et la pratique TCQ entre eux et par rapport à un groupe témoin sur une liste d’attente au moyen d’un essai novateur sur l’efficacité comparative, à répartition axée sur la préférence et aléatoire, tenant compte de facteurs modérateurs potentiels pouvant prédire un effet différentiel. 2) Étudier les effets du programme MBCR et de la pratique TCQ sur une variété de paramètres biologiques, notamment les processus immunitaires, la tension artérielle, la variabilité de la fréquence cardiaque, le taux d’hormones liées au stress, le vieillissement cellulaire et l’expression génétique.

Méthodologie : Essai sur l’efficacité comparative, à répartition axée sur la préférence et aléatoire mené dans deux établissements canadiens (Calgary, en Alberta, et Toronto, en Ontario). Participants (N total = 600). Les participants ayant une préférence pour le programme MBCR ou la pratique TCQ seront placés dans le groupe de leur intervention préférée; ceux qui n’ont pas de préférence seront répartis au hasard dans le groupe de l’une ou l’autre des deux interventions. Au sein des groupes de chacune des interventions, les participants seront également répartis aléatoirement pour recevoir une intervention immédiate ou être placés sur une liste d’attente comme témoins. Les critères qui seront évalués avant et après l’intervention, puis lors du suivi après six mois, comprennent les résultats psychologiques (humeur, stress, pleine conscience, spiritualité, croissance post-traumatique), la qualité de vie, les symptômes (fatigue, sommeil), le fonctionnement physique (force, endurance), ainsi que les analyses exploratoires des biomarqueurs (pente du taux de cortisol, cytokines, variabilité de la tension artérielle et de la fréquence cardiaque, longueur des télomères, expression génétique) et les mesures économiques de la santé. Hypothèses : Les chercheurs ont émis l’hypothèse que tant le programme MBCR que la pratique TCQ amélioreront les résultats chez les survivants par rapport au traitement habituel, particulièrement si les patients ont une préférence marquée pour une intervention particulière. Plus précisément, les chercheurs ont avancé l’hypothèse que le programme MBCR serait supérieur à la pratique TCQ en ce qui a trait aux mesures associées au stress et à l’humeur. En revanche, la pratique TCQ pourrait être supérieure au programme MBCR, en ce qui concerne l’amélioration des mesures physiques et fonctionnelles.

Description de l'essai

Primary Outcome:

  • Profile of Mood States - Total Mood Disturbance (POMS-TMD)
Secondary Outcome:
  • Pittsburgh Sleep Quality Index
  • Brief Pain Inventory
  • The Functional Assessment of Cancer Therapy - Fatigue (FACT-F)
  • POMS - Subscale scores (6)
  • Symptoms of Stress Inventory (C-SOSI-32)
  • The Functional Assessment of Cancer Therapy - General (FACT-G)
  • The Functional Assessment of Chronic Illness therapy-Spiritual Well-being (FACIT-sp)
  • Post-Traumatic Growth Inventory-Revised (PTGI-R)
  • Average Diurnal Cortisol Slope
  • Telomere length (TL) & Telomerase
  • Heart Rate (HR)/Heart Rate Variability (HRV)
  • Blood Pressure
  • Timed Up and Go Test
  • Maximal Walking Speed
  • Maximum Grip Strength
  • Single Leg Standing
  • Cytokine Production
  • Canadian Community Health Survey (CCHS)
  • EQ-5D-5L
Background While there is ample research documenting the problems people diagnosed with cancer face, including high levels of distress, anxiety, depression and symptoms such as fatigue, pain and sleep disturbance, there is also a limited but growing body of evidence supporting the efficacy of a range of mind-body therapies (MBTs) in alleviating these and other symptoms. The investigators have chosen to focus on comparing MBCR and TCQ because both have level 1 evidence in cancer care, and both have shown potential to affect important biomarkers and clinical outcomes. Both interventions are similarly rooted in meditative practice, but MBCR has greater emphasis on mental practice, while TCQ is more emphatically a body movement-based practice. The investigators also anticipate that many patients will have a preference for one or the other. Evidence for the efficacy of each will be briefly reviewed followed by details of study design and methods. Mindfulness-Based Cancer Recovery (MBCR) Through an ongoing program of research the investigators adapted a group intervention based on intensive training in mindfulness meditation (Mindfulness-Based Stress Reduction; MBSR) specifically for people with cancer, and called it Mindfulness-Based Cancer Recovery (MBCR), acknowledging the roots of the program but also that its form and content is somewhat different, and focused primarily on the challenges faced by people living with cancer. It is an 8-week program consisting of weekly group meetings of 1.5 to 2 hours, shortened from traditional MBSR based on practical logistical concerns and the needs of the study population. Home practice of 45 minutes per day (15 min yoga; 30 min meditation) is prescribed. As the weeks progress, different forms of meditation are introduced, beginning with a body scan sensory awareness experience, progressing to sitting and walking meditations. Gentle Hatha yoga is incorporated throughout, as a form of moving meditation. Didactic instruction as well as group discussion and reflection, problem solving and skillful inquiry are commonly applied teaching tools. Since 1998, the investigators have tested its efficacy in a wide range of studies and groups of people with cancer, beginning with psychological outcomes including stress symptoms, mood disturbance including anxiety, anger and depression, then expanding in scope and scale to assess effects on sleep disturbance and fatigue. The investigators also examined positive outcomes including post-traumatic growth, spirituality and benefit finding. To assess potential biological mechanisms of change, the investigators examined the effects of the program on biomarkers including blood pressure, inflammatory cytokines, stress hormones and most recently telomere length using increasingly sophisticated study designs, showing benefit across all of these measures. The investigators work on MBCR for cancer patients and survivors has spanned the spectrum of research from basic mechanistic research to clinical trials and implementation science. Others, as well, have studied MBSR with cancer patients, and several reviews and meta-analyses summarize its benefits across outcomes of anxiety, stress, mood disturbance and quality of life. Tai Chi/Qigong (TCQ) Work has also been done evaluating the efficacy of tai-chi and qigong in cancer care, and reviews are now available for both. Tai chi is a shortened name for Tai Chi Ch'uan, a form of martial art from traditional Chinese medicine. It involves a series of slow specific movements or "forms" done in a meditative fashion. It is purported that focusing the mind solely on the movements of the form helps to bring about a state of mental calm and clarity. The practice itself has been separated from its martial arts roots and is widely taught as a health behaviour practice and exercise. In cancer care, a review of seven controlled trials in breast cancer patients concluded that while tai chi helped to improve psychological and physical health measures compared to usual care, compared to other active interventions it may not be superior. Overall in elderly samples, a larger body of research supports its efficacy for improving balance and preventing falls and improving overall psychological well-being, but larger studies with better designs are needed. Similarly, a growing body of research suggests efficacy of qigong, a practice of aligning breath, movement, and awareness for exercise, healing, and meditation. Qigong is traditionally viewed as a practice to cultivate and balance qi (chi) or "intrinsic life energy". Qigong exercises generally have three components: a posture (whether moving or stationary), breathing techniques, and mental focus on guiding qi through the body. A review of the literature including Chinese and Korean databases found 23 studies in cancer care. The most consistent benefits were seen on immune system function (reduced inflammation), improved mood, quality of life, and fatigue. As is the case with tai chi studies, randomized controlled trials with larger samples sizes are necessary to generalize findings. The study protocol incorporates simple Tai Chi elements within a healing framework stemming from Qigong principles. For that reason the investigators call it Tai Chi/Qigong (TCQ).

Voir cet essai sur ClinicalTrials.gov

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