The MINDSET study is a randomized-controlled multi-site trial comparing the biological and psychological impact of the two most vigorously validated psycho-oncological interventions, Mindfulness-Based Cancer Recovery (MBCR) and Supportive Expressive Therapy (SET) for breast cancer survivors (MINDSET).
This trial was commenced in 2006 in Calgary and Vancouver, and we have accrued 271 women with Stage I – III breast cancer who were experiencing psychological distress. These women were randomly assigned to either MBCR, SET or a one-day stress management seminar (SMS), and were asked to complete a set of questionnaires and donate saliva samples prior to and following the intervention, 6-months and 12-months following the intervention. Participants in Calgary were also asked to donate blood samples at each assessment point. The project examined the impacts of these interventions on psychosocial well-being (mood disturbance, stress symptoms, quality of life), as well as cancer-related endocrinological (cortisol) and immunological markers (inflammatory cytokines, telomere length (TL)).
This study included three objectives:
The final 12-month follow-up data collection and assays of salivary cortisol were completed in 2011. TL and cytokines are currently being analysed. We analysed psychological and cortisol data from pre- and post-intervention assessments and prepared a primary outcome paper (for Objective 1) which is currently under review for publication. We also analysed moderating effects of personality and patients’ program preference on post-intervention outcomes (for Objective 2). The 6- and 12-months follow-up data are currently being analysed.
These results will be updated here once we finalize the data analyses and undergoing publications.
The I-CAN SLEEP program was a randomized non-inferiority clinical trial comparing Mindfulness-Based Stress Reduction (MBSR) to Cognitive Behavioral Therapy (CBT-I) for cancer patients with chronic insomnia.We sought to determine whether MBSR performs to the same standard as CBT-I for insomnia, while providing additional benefits such as improved mood and lower appraisals of stress. Patients underwent a thorough sleep assessment including wearing a “sleep watch” for one week prior to the program, once they completed the program, and again 3 months later. We also assessed how each of the programs impacted the patients’ mood, stress appraisals, beliefs about sleep and levels of mindfulness.
Participants in the CBT-I program reported faster reduction in insomnia severity, however in the long term, both programs produced clinically significant improvements in sleep quality and sleep quantity. At five month follow up, the CBT-I group reported a 22 minute reduction in diary reported sleep onset latency compared to 14 minutes in the MBSR group. Similar reductions in time spent awake during the night (~36 minutes) were observed for both groups. Total sleep time increased by 36 min in CBT-I and 44 min in MBSR. The two interventions were not significantly different in terms of their ability to improve stress and mood outcomes, although those receiving CBT-I uniquely improved sleep quality and dysfunctional sleep beliefs. This suggests that MBSR may be an effective treatment for people with insomnia and cancer who are seeking, or are willing to try and commit to, a mindfulness-based approach.
The I-CAN SLEEP trial was funded in part by grants from the Canadian Cancer Society Research Institute, the Alberta Cancer Board and a Francisco J. Varela award from the Mind & Life Institute. For her work on this project, Sheila Garland received a Psychosocial Oncology Research Training (PORT) fellowship and a graduate scholarship from the Social Sciences and Humanities Research Council of Canada.
The MASTER study is a waitlist-controlled trial evaluating the impact of MBSR on blood pressure, acute stress responses (neuroendocrine and cardiovascular), and psychological functioning in women with cancer (primarily breast). Results showed that MBSR participation was associated with reduced systolic blood pressure among women with cancer who had relatively high blood pressure at study outset. In addition, findings suggest that MBSR may reduce depressive symptoms through decreased rumination (perseverative thinking about threats, losses and injustices to the self), in this patient group. In sum, the MASTER study represents a preliminary examination of the potential cardiovascular benefits of MBSR for cancer patients, and points to reduced rumination as a potential mechanism leading to reduced depressive symptoms.
We would like to acknowledge the Canadian Breast Cancer Research Alliance, Alberta Innovates Health Solutions, and the Social Sciences and Humanities Research Council for funding this study.
Several well-designed studies have shown that MBSR improves mood and reduces symptoms of stress for cancer patients and survivors. There is also evidence that MBSR enhances spirituality and personal growth through the often traumatic experience of cancer. However, we know little about the program’s mechanisms of action, that is, “how” MBSR leads to these positive changes for cancer patients and survivors.
MINDinMOTION is a waitlist-controlled longitudinal study that examined how the MBSR program may lead to improved psychological functioning for cancer patients. Specifically, increased mindfulness and enhanced emotion regulation were tested as potential pathways of change (i.e., “mediators” of changes in outcomes) through the program. The study is also the first, to our knowledge, to consider the timing and sequence of change when testing mediators of MBSR. Results help us understand how MBSR “works”, and may inform future modifications of the program making it more effective and efficient.
Results of MINDinMOTION have been submitted for publication. We would like to acknowledge the Mind and Life Institute for funding this study through a Francisco J. Varela Research Award.
The eCalm Study
For people with cancer, in-person Mindfulness-Based Stress Reduction (MBSR) participation can decrease stress symptoms, mood disturbance, and fatigue, as well as enhance personal growth and spirituality, and improve quality of life and sleep. Online MBSR may improve the accessibility of MBSR programs to underserved cancer patients who are unable to attend available in-person groups. This study will examine whether patients are willing to participate and complete the program, and also whether the online program improves mood and stress.
-18 years of age or older
-Speak and read English sufficiently to complete questionnaires
-Women and men who have been diagnosed with any type of cancer, at any time in the past with no restriction on tumor site
-Pre or post primary cancer treatment, up to having completed primary cancer treatment within the last 36 months
-Exhibiting moderate distress
-Willing to participate in the intervention requirements; able to participate in the intervention (2 hrs per week for 8 weeks and a full day online retreat)
-Have Internet access
-Is a Resident of Alberta, who has limited access to in-person cancer-specific MBSR programs
-Presence of major self-reported psychiatric disorder not in remission, current substance abuse/dependence, and psychotic symptoms
-Previous participation in a MBSR program
CAM Use and Knowledge Surveys
Many cancer patients are looking beyond conventional treatment and therapies, to complementary and alternative medicine (CAM), to help them cope with and treat their disease. Approximately two thirds of cancer patients report using CAM. However, only approximately 30% of cancer patients discuss their use of CAM with their health care practitioners (HCPs). Though patients express a desire to obtain CAM information from their HCPs, as they trust the guidance HCPs provide, they receive the majority of information about CAM from their family and friends. This gap in CAM communication may be related to many HCPs admitting they are not knowledgeable about CAM and do not discuss CAM with their patients. There is potential for misuse and harm when using CAM, especially those practices and/or products that have not been well studied. These potential risks to patient health necessitate a better understanding of patient and HCP knowledge, use, and beliefs about CAM. This understanding will facilitate the safe and effective utilization of CAM. To obtain such an understanding, a survey of cancer patients and cancer health care practitioners is currently underway. These surveys aims to determine the current use, understanding, and interest in CAM demonstrated by patients at the Tom Baker Cancer Centre (TBCC). The factors motivating and preventing patients from using CAM are also being examined. We aim to determine which patient CAM needs are being met, and which are not being met, at the TBCC. In addition, we are examining HCPs current knowledge and beliefs about CAM and how these impact HCPs interactions with, and recommendations to, patients. 481 cancer patients have been surveyed at the outpatient clinics at the TBCC and Holy Cross Centre (HCC). The data from these surveys is currently being analyzed. As well, approximately 50 HCPs have already been surveyed. Data collection is still underway with HCPs. Once collection is completed, data analysis will be conducted. Results from these surveys will be available in April 2013. The information provided by the surveys will provide a baseline for the creation and improvement of educational CAM programs, for both patients and HCPs, at the TBCC.
Natural Health Product Review
Natural health products (NHPs) are a form of complementary and alternative medicine that includes such items as vitamins, minerals, herbal medicines, and food products. Over half of cancer patients report using such products. With such a large proportion of patients using NHPs, an understanding of the efficacy and safety of these products is necessary to ensure patient wellbeing. The issue faced by patients and health care providers, especially given that approximately half of the patients using NHPs do not discuss their use with their providers, is the large extent of misinformation surrounding NHPs. In an effort to combat this misinformation, a thorough review of the research on NHPs was conducted. Though there are currently two databases that do cover NHPs, neither database is publically available nor do they have information on various NHPs. This review aimed to build on these databases by disseminating the information gained to an understandable and manageable level that is accessible for both patients and providers. Over 700 scientific studies on approximately 70 NHPs were reviewed. The studies were reviewed for the quality of the methods, the participants, the type of cancer of the participants, and the results. This information, along with ratings established by the two databases mentioned previously, was compiled into a single database. From this database, each product, for the type of cancer it had been studied in, was rated as “green”, “yellow”, or “red”. “Green” products are those that patients can safely use and that have been shown to be beneficial for patient health and/or survival. “Yellow” products are those for which there is mixed evidence, with some showing benefits of the product, and other showing the product has no impact. “Red” products are those that have been shown to negatively impact patient survival and health and should thus be avoided by patients. This rating system was used as it is very intuitive and can easily be understood by patients. The results of the review, including the ratings, have been presented to patients at several of the monthly complementary and alternative medicine classes offered by Dr. Carlson at the Tom Baker Cancer Centre. Attendees of the class have responded to the presentation format favorably and have shown a lot of interest in learning more about NHPs. As well, there is an ongoing effort to make the database created via this review available online. Once the online programming work is completed, the database will be publically accessible online and will be searchable by product, cancer type, rating, and by product impact (i.e., cancer prevention or cancer/side effect treatment). Future work with this database will include updating it with the most recent research and extending the presentation of the findings to a format suitable for interested health care providers.