The ONE-MIND Study: Rationale and protocol for assessing the effects of ONlinE MINDfulness-based cancer recovery for the prevention of fatigue and other common side effects during chemotherapy.

Cancer patients often experience poor quality of life (QoL) during chemotherapy (CT) treatments due to side effects including fatigue, insomnia, pain and nausea/vomiting. Mindfulness-based cancer recovery (MBCR) is an evidence-based intervention for treating such symptoms, but has not been investigated as an adjunctive treatment during CT. This study aims to determine the efficacy of an online group MBCR programme delivered during CT in 12 real-time interactive weekly sessions for managing fatigue (primary outcome). Secondary outcomes include sleep disturbance, pain, nausea/vomiting, mood, stress and QoL. Exploratory outcomes include cognitive function, white blood cell counts and return to work. The study is a two-armed randomised controlled waitlist trial with 2:1 allocation to treatment (online group MBCR during CT) or control (waitlist usual care; online MBCR following CT completion) with a target sample size of N = 178. Participants are breast or colorectal cancer patients undergoing common CT regimens in Calgary, Canada. Online assessments using validated self-reported instruments will take place at baseline, post-MBCR, post-CT and 12 months' post-baseline. If online MBCR delivered during CT significantly reduces fatigue in cancer patients' post-CT and also impacts secondary symptoms, this would provide evidence for including mindfulness training as an adjunctive symptom management therapy during CT.

The Role of Hypnosis in Cancer Care.

PURPOSE OF REVIEW: This paper reviews the current evidence-base for the use of hypnosis as an adjunct treatment for common cancer-related symptoms and side effects, including those experienced during treatment, as well as long-term and late effects. First, a general description and history of medical hypnosis in cancer care is provided, followed by a review of the latest evidence across a range of common symptoms. RECENT FINDINGS: The evidence suggests that hypnosis may help treat symptoms of nausea and vomiting in breast cancer patients, manage pain in a variety of contexts, and also reduce levels of anxiety and overall distress around surgical and medical procedures, both in children and adults. Emerging research shows promise for treating hot flashes in women with breast cancer. The research in this area would benefit from assessing populations beyond women with breast cancer, including late-stage disease, using more rigorous study designs, following published reporting guidelines and better describing and standardizing interventions.

Effects of a light therapy intervention on diurnal salivary cortisol in fatigued cancer survivors: A secondary analysis of a randomized controlled trial.

OBJECTIVE: Altered diurnal cortisol rhythms are a potential mechanism through which symptoms of fatigue are maintained in post-treatment cancer survivors. Exposure to early morning bright light may target this underlying dysregulation, resulting in improved diurnal cortisol patterns, subsequently improving symptoms of fatigue. This research investigates the effects of a 4-week light therapy intervention on the diurnal cortisol slopes and output in fatigued cancer survivors. METHODS: Post-treatment adult cancer survivors who met diagnostic criteria for cancer-related fatigue were randomly assigned to receive either a bright white light (BWL) or dim red light (DRL) device, used daily for 30 min over four consecutive weeks. Assessments of fatigue and salivary cortisol were collected at baseline and post-intervention. Cortisol was sampled four times per day (waking, noon, 5 pm, bedtime) for three days at each timepoint. Diurnal cortisol slopes and total cortisol output were calculated at baseline and post-intervention. Linear mixed models were used to analyze the data. RESULTS: Seventy-seven participants were included in this analysis (BWL n = 40; DRL n = 37). Participants in both groups displayed increased steepness in cortisol slope (B = -0.02, p = .01, Cohen's d = 0.57) and increased total cortisol output (B = 9.58, p = .03, Cohen's d = 0.49) from baseline to post-intervention, indicating only a moderate effect of time. Neither diurnal cortisol slopes nor total cortisol output mediated the relationship between the light therapy intervention and fatigue levels. CONCLUSION: Though the results of this trial are promising for light therapy as an effective intervention to reduce fatigue in cancer survivors, this does not appear to be achieved through alterations in neuroendocrine function. ClinicalTrials.gov registration #: NCT01780623.

A Smartphone App-Based Mindfulness Intervention for Cancer Survivors: Protocol for a Randomized Controlled Trial.

BACKGROUND: Cancer patients transitioning to survivorship after completing cancer treatments need psychosocial interventions to manage stressors such as anxiety, depression, and fear of cancer recurrence. Mindfulness-based interventions (MBIs) are effective for treating these symptoms; however, cancer survivors are often unable to participate in face-to-face interventions because of difficulties such as work and family commitments, treatment-related side-effects, scheduling conflicts, and geography. Smartphone app-based MBIs are an innovative way to deliver psychosocial cancer care and can overcome several such difficulties, since patients can participate at their own convenience. OBJECTIVE: The SEAMLESS (Smartphone App-Based Mindfulness Intervention for Cancer Survivors) study aims to evaluate the efficacy of a tailored app-based mindfulness intervention for cancer survivors (the Am Mindfulness-Based Cancer Survivorship-MBCS-Journey) for treating (1) symptoms of stress (primary outcome), as well as (2) fear of cancer recurrence, anxiety, depression, fatigue, and overall physical functioning (secondary outcomes). This is the first Canadian efficacy trial of a tailored mindfulness app intervention in cancer survivors. METHODS: This is a randomized waitlist-controlled trial, which will evaluate the effectiveness of Am MBCS for impacting the primary and secondary outcomes in cancer survivors who have completed all their cancer treatments. Outcomes will be assessed using web-based surveys with validated psychometric instruments at (1) baseline, (2) mid-intervention (2 weeks later), (3) immediately postintervention (4 weeks), (4) 3 months postbaseline, (5) 6 months postbaseline, and (6) 12 months postbaseline. The waitlist group will complete all assessments and will cross over to the intervention condition after the 3-month assessment. In addition, data will be obtained by the smartphone app itself, which includes users' engagement with the app-based intervention, their emotional state (eg, angry and elated) from a user-inputted digital emotion-mapping board, and psychobiometric data using photoplethysmography technology. RESULTS: The study received ethics approval in September 2018 and recruitment commenced in January 2019. Participants are being recruited through a provincial cancer registry, and the majority of participants currently enrolled are breast (44/83, 53%) or colorectal (17/83, 20%) cancer survivors, although some survivors of other cancer are also present. Data collection for analysis of the primary outcome time-point will be complete by September 2019, and the follow-up data will be collected and analyzed by September 2020. Data will be analyzed to determine group differences using linear mixed modelling statistical techniques. CONCLUSIONS: Cancer care providers are uncertain about the efficacy of app-based mindfulness interventions for patients, which are available in great supply in today's digital world. This study will provide rigorously evaluated efficacy data for an app-based mindfulness intervention for cancer survivors, which if helpful, could be made available for psychosocial care at cancer centers worldwide. TRIAL REGISTRATION: ClinicalTrials.gov NCT03484000; https://clinicaltrials.gov/ct2/show/NCT03484000. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15178.

Integrative Approaches to Stress Management.

This narrative review provides an overview of the scope of psychosocial distress and stress in cancer patients and survivors and the potential negative consequences of untreated symptoms. Evidence-based interventions to treat these symptoms are reviewed, beginning with a summary of published clinical practice guidelines, followed by more detailed reviews of the specific integrative interventions with the largest empirical support: cognitive-behavioral stress management, yoga, mindfulness-based interventions, and massage. We also comment on use of natural health products because of their popularity. Finally, we conclude with recommendations to improve the quality of research in integrative interventions for stress management.

Integrative Oncology Trials in the Real World: Assessing the Pragmatism of an Ongoing Integrative Oncology Trial of Mindfulness and T'ai Chi/Qigong.

OBJECTIVES: The aim of this study was to highlight features of pragmatic real-world integrative oncology research by applying the PRagmatic Explanatory Continuum Indicator Summary (PRECIS-2) criteria to an ongoing integrative oncology clinical trial. The ongoing trial is a preference-based randomized comparative effectiveness trial of mindfulness-based cancer recovery (MBCR) versus t'ai chi/qigong (TCQ) for cancer survivors (the Mindfulness and T'ai Chi for Cancer Health [MATCH] study). The primary outcome of the MATCH study is distress, and secondary outcomes are quality of life, sleep disturbance, and physical functioning. The clinical trial is being undertaken at tertiary care cancer centers across two sites in Canada: Calgary (AB) and Toronto (ON), with a sample of 600 cancer survivors who have finished all cancer treatments and are distressed. METHODS AND RESULTS: The MATCH trial was scored on the explanatory-pragmatic continuum for each of the nine domains of the PRECIS-2 criteria on a scale of 1-5, and was rated as more explanatory than pragmatic, despite initial design efforts being more pragmatic. Areas that were least pragmatic were methods of recruitment, follow-up, and intervention delivery. The more pragmatic areas were setting, outcomes, and data analysis. CONCLUSIONS: More efforts toward conducting pragmatic trials are needed in the field of integrative oncology, as cancer-care institutions and policy makers are looking for sustainable interventions within already established treatment models. The PRECIS-2 criteria can help researchers meet these goals in the planning stages of trial development.

Psychosocial therapies for patients with cancer: a current review of interventions using psychoneuroimmunology-based outcome measures.

BACKGROUND: As part of a new standard of quality cancer care, the Institute of Medicine has recommended inclusion of therapies that address psychosocial needs of cancer patients. A range of psychosocial therapies for managing acute and chronic stress have been developed for patients with cancer, based on the scientific framework of psychoneuroimmunology (PNI). The current review aimed to identify studies of new and emerging PNI-based psychosocial therapies in patients with cancer that have used neuroendocrine-immune biomarkers as outcomes. Specifically, this review aimed to evaluate studies based on the cancer populations involved, types of psychosocial therapies, and PNI measures employed. METHOD: Methodology was guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The PubMed, EMBASE, PsychINFO, CINAHL, and Google Scholar online databases were searched using combinations of keywords obtained from previous reviews of psychosocial interventions. Studies from 2001 to 2012 were included if they ( : ) were published in English, ( : ) used experimental or quasi-experimental designs, ( : ) evaluated psychosocial therapies, ( : ) involved cancer patients, and ( : ) reported results on at least one neuroendocrine or immune outcome measure. The search strategy identified 403 records and 2 stages of screening were used to eliminate irrelevant studies. RESULT: A total of 24 cancer-specific studies of psychosocial therapies that used PNI-based outcome measures were included in this review. Most studies included early-stage breast cancer patients, and 2 major types of therapies emerged, cognitive-behavioral therapies and complementary medical therapies. Durations of interventions ranged widely, from 1.3 hours over a single week to 27 hours over 18 weeks. Considerable diversity in PNI outcomes made statistical comparisons problematic. Studies of cognitive-behavioral therapies were found to have reported the most success in impacting PNI-based measures, which were typically functional measures of the immune system, for example, cytokines. CONCLUSION: Several issues related to research methodology are discussed. Most important, studies examining dose-response associations and resource allocation are needed to guide future research. A standardized panel of psychosocial instruments and biomarkers for PNI-based studies would enhance comparability of findings across studies when evaluating this body of research and assist with integrating psychosocial therapies into the standard of cancer care.