Four-Year Trajectories of Symptoms and Quality of Life in Individuals Hospitalized After Mild Traumatic Brain Injury.

OBJECTIVES: To (1) detect distinct trajectories of symptoms and quality of life (QoL) over the first 4 years after mild traumatic brain injury (mTBI); (2) assess the relationship between symptom trajectory membership and QoL trajectory membership; and (3) identify participant characteristics associated with QoL trajectory membership. DESIGN: Prospective longitudinal cohort study. Assessments occurred at 4, 8, 12, 24, 36, and 48 months after mTBI. SETTING: Recruitment occurred in Level 1 Trauma Centers; follow-up was completed in the community. PARTICIPANTS: Participants were 143 adults (aged 18-65y) who sustained an mTBI and were hospitalized (≥24h) at a Level 1 Trauma Center. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Fatigue Severity Scale, Hospital Anxiety and Depression Scale, Insomnia Severity Index, Medical Outcomes Study Cognitive Functioning Scale, Quality of Life after Brain Injury questionnaire, presence/absence of headaches or dizziness. RESULTS: Group-based trajectory modeling revealed relatively stable symptom and QoL trajectories over time. Considerable percentages of participants were classified in trajectories of clinically significant symptoms throughout the full follow-up period: 62% for subjective cognitive issues, 54% for fatigue, 44% for anxiety, 43% for insomnia, 27% for depression, 23% for headaches, and 17% for dizziness. Sixty-six percent of participants belonged to trajectories of persistently poor QoL. For all symptoms, trajectories of greater severity were associated with trajectories of poorer QoL. None of the sociodemographic or injury-related variables examined were associated with QoL trajectory membership. CONCLUSIONS: A substantial proportion of individuals hospitalized after mTBI experiences clinically significant persistent symptoms ≤4 years after injury, and those with more severe symptoms have poorer QoL. Further research is required to better understand the factors leading to symptom persistence and poor QoL.

Fear of cancer recurrence in breast cancer survivors carrying a BRCA1 or 2 genetic mutation : a cross-sectional study.

BACKGROUND: Fear of cancer recurrence (FCR) affects virtually all patients who have been treated for cancer, to varying degrees. Breast cancer survivors who carry a BRCA1 or BRCA2 gene mutation are at high risk of cancer recurrence. No study has yet assessed FCR specifically in this population. OBJECTIVES: This cross-sectional study, conducted in women who were treated for breast cancer and carrying a BRCA1/2 mutation, aimed to: (1) assess the mean level of FCR and estimate the proportion of patients with clinical levels of FCR; (2) examine the relationships between FCR and selected psychological variables (e.g., avoidance, intolerance to uncertainty) and quality of life; (3) explore whether FCR levels vary as a function of the past preventive treatment received; and (4) to assess the associations between FCR and the presence of decisional conflict or regret regarding the various preventive options. METHOD: Participants were recruited through an e-mail sent to an oncogenetic network mailing list (Réseau ROSE). Participants were asked to complete a battery of questionnaires online assessing FCR and other psychological and quality of life variables. RESULTS: A total of 89 women completed the survey. Most participants had undergone a preventive mastectomy (62.9%) and a preventive salpingo-oophorectomy (75.3%) at the time of the study. The mean Fear of Cancer Recurrence Inventory-severity score was 16.8, which exceeds the clinical cut-off score of 13, and 70.8% of the participants showed a clinical level of FCR. FCR was significantly associated with higher levels of anxiety and depression, and higher avoidance and intolerance of uncertainty, but not with quality of life. No significant difference was observed on the total FCR score between women who had received preventive surgery (mastectomy and/or salpingo-oophorectomy) and those considering it, and those not considering it. The association was significant between higher FRC scores and greater decisional conflicts and regrets about choosing to undergo preventive surgery. CONCLUSION: These data suggest that FCR is a significant problem for breast cancer survivors carrying a BRCA1/2 genetic mutation, even after undergoing a prophylactic surgery. This highlights the importance of providing these women with specific psychological intervention focusing on FCR.

What is the prevalence of fear of cancer recurrence in cancer survivors and patients? A systematic review and individual participant data meta-analysis.

OBJECTIVE: Care for fear of cancer recurrence (FCR) is considered the most common unmet need among cancer survivors. Yet the prevalence of FCR and predisposing factors remain inconclusive. To support targeted care, we provide a comprehensive overview of the prevalence and severity of FCR among cancer survivors and patients, as measured using the short form of the validated Fear of Cancer Recurrence Inventory (FCRI-SF). We also report on associations between FCR and clinical and demographic characteristics. METHODS: This is a systematic review and individual participant data (IPD) meta-analysis on the prevalence of FCR. In the review, we included all studies that used the FCRI-SF with adult (≥18 years) cancer survivors and patients. Date of search: 7 February 2020. Risk of bias was assessed using the Joanna Briggs Institute critical appraisal tool. RESULTS: IPD were requested from 87 unique studies and provided for 46 studies comprising 11,226 participants from 13 countries. 9311 respondents were included for the main analyses. On the FCRI-SF (range 0-36), 58.8% of respondents scored ≥13, 45.1% scored ≥16 and 19.2% scored ≥22. FCR decreased with age and women reported more FCR than men. FCR was found across cancer types and continents and for all time periods since cancer diagnosis. CONCLUSIONS: FCR affects a considerable number of cancer survivors and patients. It is therefore important that healthcare providers discuss this issue with their patients and provide treatment when needed. Further research is needed to investigate how best to prevent and treat FCR and to identify other factors associated with FCR. The protocol was prospectively registered (PROSPERO CRD42020142185).

"I Beat Cancer to Feel Sick:" Qualitative Experiences of Sleep Disturbance in Black Breast Cancer Survivors and Recommendations for Culturally Targeted Sleep Interventions.

BACKGROUND: Sleep disturbance is common and distressing among cancer survivors. Black breast cancer survivors (BBCS) suffer disproportionately from sleep disturbance, yet there is limited research on how to address this issue. PURPOSE: This study aimed to understand the multifaceted experiences of sleep disturbance among BBCS and how to culturally target a mobile health (mHealth) intervention to improve sleep outcomes in BBCS. METHODS: Semi-structured interviews were conducted in a purposive sample of 10 BBCS. Interviews were audio-recorded, transcribed, and coded for key barriers to sleep and potential solutions to incorporate into behavioral interventions using NVivo 12. Inductive applied thematic analysis techniques were employed to identify emergent themes. RESULTS: Ten BBCS (mean age = 54, SD = 10) described their experiences of sleep disturbance with themes including: (1) barriers to quality sleep (e.g., cancer worry, personal responsibilities), (2) psychosocial impacts of sleep disturbance (e.g., fatigue, distress), and (3) commonly used strategies to improve sleep. The second section discusses suggestions for developing mHealth interventions to improve sleep for BBCS including: (1) feedback on an existing mHealth intervention and (2) intervention topics suggested by BBCS. CONCLUSIONS: Our findings highlight the challenges associated with sleep disturbance in BBCS. Participants report culturally targeted mHealth interventions are needed for BBCS who experience chronic sleep disturbance that affects their overall quality of life. These interventions should address coping with sleep-related issues relevant to many breast cancer survivors and BBCS (e.g., sexual intimacy, fear of cancer recurrence) and should incorporate intervention strategies acceptable to BBCS (e.g., prayer, meditation).

Barriers and facilitators to implementing a stepped care cognitive-behavioral therapy for insomnia in cancer patients: a qualitative study.

PURPOSE: Insomnia affects 30-60% of cancer patients and tends to become chronic when left untreated. While cognitive-behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment, this intervention is not readily accessible. This qualitative study investigated current practices in the assessment and management of insomnia in five hospitals offering cancer care and identified the barriers and facilitators to the implementation of a stepped care CBT-I (i.e., web-based CBT-I followed, if needed, by 1-3 booster sessions) in these settings. METHODS: Nine focus groups composed of a total of 43 clinicians (e.g., physicians, nurses, radiation therapists, psychologists), six administrators, and 10 cancer patients were held. The Consolidated Framework for Implementing Research (CFIR) was used to develop the semi-structured interview and analyze the data. RESULTS: Sleep difficulties are not systematically discussed in clinical practice and when a treatment is offered, most often, it is a pharmacological one. Barriers and facilitators to the implementation of a stepped care CBT-I included individual characteristics (e.g., lack of knowledge about CBT-I); intervention characteristics (e.g., increased accessibility offered by a web-based format); inner setting characteristics (e.g., resistance to change); and process factors (e.g., motivation to offer a new service). CONCLUSIONS: This qualitative study confirms the need to better address insomnia in routine cancer care and suggests that, while some barriers were mentioned, the implementation of a stepped care CBT-I is feasible. Keys to a successful implementation include accessibility, training, inclusion of stakeholders in the process, and ensuring that they are supported throughout the implementation.

Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors.

Cognitive-Behavioral Therapy for Insomnia (CBT-I) is the gold-standard treatment for insomnia, which is common among breast cancer survivors (BCS). This pilot randomized controlled trial tested the first CBT-I intervention for Spanish-speaking BCS delivered using eHealth. Participants (N = 30) were Spanish-speaking BCS with insomnia symptoms recruited in Puerto Rico and randomized to a 6-week eHealth CBT-I group intervention or a waitlist control. Primary outcomes were acceptability (recruitment, treatment satisfaction) and feasibility (retention, attendance). Secondary outcomes were group differences in sleep outcomes post-treatment (i.e., insomnia symptoms, sleep disturbance, sleep efficiency). Recruitment (95%) and retention (97%) were excellent. All CBT-I participants (100%) attended ≥ 3 of 6 sessions. Satisfaction with CBT-I was acceptable. Post-intervention, there were medium to large group differences for average insomnia symptoms (d = 1.02), sleep disturbance (d = 1.25), and sleep efficiency (d = 0.77) favoring CBT-I. There were small/medium to medium/large group differences for the proportion of participants with clinically significant insomnia symptoms (d = 0.52), sleep disturbance (d = 0.67), and low sleep efficiency (d = 0.33) favoring CBT-I. Spanish-language eHealth CBT-I for BCS was acceptable and feasible and showed preliminary efficacy.ClinicalTrials.gov TRN: NCT04101526 (Posted September 24, 2019).

A 2-year prospective analysis of insomnia as a mediator of the relationship between androgen deprivation therapy and perceived cognitive function in men with prostate cancer.

BACKGROUND: Androgen deprivation therapy (ADT) may affect cognitive function in men with prostate cancer (PCa). This study examined whether insomnia symptoms mediate the relationship between ADT and perceived cognitive function and whether depressive symptoms, fatigue severity, and physical activity moderate the strength of this relationship. METHODS: This was a prospective study of ADT recipients (n = 83) who were matched with control patients with PCa who were not on ADT (n = 92) and with controls with no history of cancer (n = 112) over a 2-year follow-up period. Perceived cognitive function and satisfaction were assessed with the Everyday Cognition Scale. Insomnia was assessed with the Insomnia Severity Index. Multilevel mediation analyses were conducted to estimate the indirect effect of ADT on perceived cognitive function through insomnia symptoms. Exploratory moderated mediation analyses assessed whether the indirect effect of ADT on perceived cognitive function through insomnia symptoms was dependent on levels of fatigue, depression, or physical activity. RESULTS: Insomnia symptoms significantly mediated the relationship between receipt of ADT and perceived cognitive function (P < .001) and satisfaction with cognition (P < .001) after controlling for comorbidities. Men with greater fatigue had a more pronounced association of ADT with insomnia severity. Men with greater depressive symptoms had a stronger association between insomnia severity and worse perceived cognitive function. Physical activity was not a significant moderator of the relationship between ADT and perceived cognitive function. CONCLUSIONS: Insomnia influenced the relationship between ADT and perceived cognitive abilities. Interventions to address insomnia, fatigue, and depression may improve perceived cognitive function.

Video cognitive-behavioral therapy for insomnia in cancer patients: A cost-effective alternative.

OBJECTIVE: Despite its high prevalence, cancer-related insomnia typically remains untreated because of a lack of access to cognitive-behavioral therapy for insomnia (CBT-I), the treatment of choice for this condition. While face-to-face CBT-I appears to be optimal in terms of efficacy, self-administered formats may be more cost-effective. The goal of this secondary analysis of a randomized clinical trial was to compare the cost-effectiveness of a professionally-based CBT-I (PCBT-I) to that of a video-based CBT-I (VCBT-I). METHODS: A total of 161 women with breast cancer received six weekly, individual CBT-I sessions (PCBT-I; n = 81) or a 60-minutes animated video +6 short booklets (VCBT-I; n = 80). Participants completed the Insomnia Severity Index (ISI) and provided information to calculate treatment costs. RESULTS: Total per patient treatment costs were 5.5 times greater for PCBT-I ($1298.90) than VCBT-I ($234.36; P < .0001). Both at posttreatment and 3-month follow-up, the ISI reduction was greater in PCBT-I than VCBT-I, but these differences were not significant (P = .09 and P = .24, respectively). In contrast, the cost-effectiveness ratio was significantly more advantageous for VCBT-I than PCBT-I. Compared to VCBT-I, each reduction of 1 unit on the ISI produced by PCBT-I was associated with a treatment cost that was significantly greater at posttreatment ($186.95 CAD vs $44.87 CAD; P = .001) and follow-up ($154.76 vs $24.97, P = .005). CONCLUSIONS: Although CBT-I is slightly less efficacious when self-administered, it constitutes a much more cost-effective alternative than face-to-face CBT-I and represents an extremely valuable option in settings where monetary and human resources required to administer CBT-I are not available or sufficient.

How did women with breast cancer experience the first wave of the COVID-19 pandemic? A qualitative study.

OBJECTIVE: The ongoing COVID-19 global pandemic is a stressful experience that is particularly likely to negatively affect cancer patients. The goal of this qualitative study was to explore how breast cancer patients experienced the first wave of the COVID-19 outbreak. METHODS: As part of a larger study, 23 women accepted to take part in an individual phone interview investigating the psychosocial consequences of the COVID-19 pandemic. RESULTS: The hybrid inductive-deductive thematic analysis revealed the following themes: (1) increased general psychological distress; (2) concerns about the impact of treatment-related immunosuppression (i.e., increased risk of catching the SARS-CoV-2 and of developing more severe complications); (3) higher risk of catching the SARS-CoV-2 in the hospital; (4) possible impact of changes in cancer care trajectory on prognosis; (5) distress related to going to treatment alone; (6) social isolation and decreased family relationships; (7) increased responsibility at home; (8) variety of coping strategies used (i.e., adherence to public health measures, seeking professional help, avoidance); (9) difficulty receiving professional mental health services and social support; (10) anxiety related to return to work; and (11) uncertainty about the future. CONCLUSIONS: The COVID-19 outbreak is a major medical, psychological, social, and occupational stressor for women undergoing treatment for breast cancer. We offer recommendations to reduce the impact of subsequent waves of COVID-19 and other epidemics in this population.

Feasibility of a video-based cognitive behavioral therapy for insomnia in French adult cancer outpatients: results from the Sleep-4-All-1 study.

BACKGROUND: Insomnia affects up to 63% of patients with cancer. Cognitive behavioral therapy for insomnia (CBT-I) is considered to be the non-pharmacological gold standard treatment, but it remains underutilized in France. Self-administered interventions offer new ways to overcome some of the barriers that restrict access to efficacious supportive care. OBJECTIVE: To assess the feasibility, among French adult cancer outpatients, of a validated Quebec video-based, self-administered, cognitive behavioral therapy for insomnia (VCBT-I). METHODS: A pre-post design with quantitative measures (Insomnia Severity Index, Edmonton Symptom Assessment System, Treatment Perception Questionnaire) and qualitative measures (semi-structured interviews) was used. RESULTS: One hundred and seventy-three cancer outpatients were self-screened for insomnia, and 57% (n=99) reported significant symptoms. Among them, 80% (n=79) agreed to participate in the VCBT-I. The download rate of the VCBT-I was 78% (n=62/79). Several technical and contextual barriers to the delivery and the applicability of the VCBT-I emerged. However, participants reported a high level of satisfaction, and some valuable benefits at post-immediate intervention (increased knowledge about sleep, better quality of sleep, and higher acceptance of the burden of insomnia), regardless of whether or not they still had insomnia. DISCUSSION: This study confirms that there is a demand for a VCBT-I, which was perceived as appropriate by a sample of French cancer outpatients with insomnia, but it also highlights some limitations in terms of implementation and practicality. Remote professional support appears to be a core need in order to address these issues and personalize the guidance process.

Prevalence, risk factors, and trajectories of sleep disturbance in a cohort of African-American breast cancer survivors.

PURPOSE: Sleep disturbance may be an overlooked modifiable risk factor for health disparities among African-American breast cancer survivors (AABCS). This study aimed to identify the prevalence of and risk factors for sleep disturbance in a cohort of AABCS. METHODS: The study was conducted among participants in the Women's Circle of Health Follow-up Study, a longitudinal study of breast cancer in 10 counties in New Jersey. Cases were identified shortly after diagnosis by the New Jersey State Cancer Registry. Self-reported sleep disturbance (Pittsburgh Sleep Quality Index) and other factors (e.g., socioeconomic status, menopausal status) were assessed at pre-diagnosis (n = 637), 10 months post-diagnosis (n = 261), and 24 months post-diagnosis (n = 632). Clinical data were obtained via medical record abstraction, and height and weight were measured by study staff. RESULTS: Most AABCS (57%) reported clinically significant sleep disturbance before diagnosis, and this rate remained largely unchanged at 10 months (53%) and 24 months post-diagnosis (61%). Average sleep disturbance scores indicated clinically significant disturbance at all three assessments (M range = 6.67-7.57). Most reported sleeping fewer than the recommended 7 hours per night at each assessment (range 57-65%). Risk factors for sleep disturbance were identified at each assessment, including pre-diagnosis (less education), 10 months post-diagnosis (lack of insurance, treatment with chemotherapy), and 24 months post-diagnosis (younger age, less education, lower income, obesity, and lymphedema). Treatment with endocrine therapy was a protective factor at 10 months post-diagnosis. CONCLUSION: Most AABCS report clinically significant sleep disturbance from before diagnosis through 24 months post-diagnosis. These rates appear indicate AABCS experience significant sleep-related disparities.

Feasibility of a Preventive Intervention for Insomnia in Women with Breast Cancer Receiving Chemotherapy.

Objective/Background: Breast cancer patients display high rates of insomnia and chemotherapy treatments appear to contribute significantly to the development of sleep disturbances among this population. The efficacy of cognitive-behavioral therapy for insomnia (CBT-I) is now well established for treating insomnia comorbid with cancer but is not widely accessible and is also fairly costly. Its capacity to prevent the onset of insomnia symptoms in cancer patients who are at a high risk of developing these difficulties remains to be demonstrated. The purpose of this study was to assess the feasibility of a brief self-administered preventive intervention of insomnia in breast cancer patients about to undergo chemotherapy. Participants/Methods: A sample of 20 women with breast cancer and with no insomnia were recruited and received the preventive intervention, taking the form of a short booklet, at their first chemotherapy treatment. One month later, a semi-structured phone interview was conducted to assess their satisfaction with different aspects of the booklet (e.g., format, content) and their adherence to the proposed strategies and to collect qualitative information. A 3-month follow-up evaluation was also conducted. Results: Patients reported a higher level of satisfaction than expected (mean score corresponding to "a lot" on the scale) and a moderate level of adherence falling only slightly under the hypothesized level. The open comments collected corroborated the good acceptability of this minimal preventive CBT-I in breast cancer patients initiating chemotherapy. Conclusions: Overall, findings of this study confirm that a self-administered preventive intervention for insomnia is feasible and a promising approach in breast cancer patients about to initiate chemotherapy.

Moderators of the effect of psychosocial interventions on fatigue in women with breast cancer and men with prostate cancer: Individual patient data meta-analyses.

OBJECTIVE: Psychosocial interventions can reduce cancer-related fatigue effectively. However, it is still unclear if intervention effects differ across subgroups of patients. These meta-analyses aimed at evaluating moderator effects of (a) sociodemographic characteristics, (b) clinical characteristics, (c) baseline levels of fatigue and other symptoms, and (d) intervention-related characteristics on the effect of psychosocial interventions on cancer-related fatigue in patients with non-metastatic breast and prostate cancer. METHODS: Data were retrieved from the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) consortium. Potential moderators were studied with meta-analyses of pooled individual patient data from 14 randomized controlled trials through linear mixed-effects models with interaction tests. The analyses were conducted separately in patients with breast (n = 1091) and prostate cancer (n = 1008). RESULTS: Statistically significant, small overall effects of psychosocial interventions on fatigue were found (breast cancer: ß = -0.19 [95% confidence interval (95%CI) = -0.30; -0.08]; prostate cancer: ß = -0.11 [95%CI = -0.21; -0.00]). In both patient groups, intervention effects did not differ significantly by sociodemographic or clinical characteristics, nor by baseline levels of fatigue or pain. For intervention-related moderators (only tested among women with breast cancer), statistically significant larger effects were found for cognitive behavioral therapy as intervention strategy (ß = -0.27 [95%CI = -0.40; -0.15]), fatigue-specific interventions (ß = -0.48 [95%CI = -0.79; -0.18]), and interventions that only targeted patients with clinically relevant fatigue (ß = -0.85 [95%CI = -1.40; -0.30]). CONCLUSIONS: Our findings did not provide evidence that any selected demographic or clinical characteristic, or baseline levels of fatigue or pain, moderated effects of psychosocial interventions on fatigue. A specific focus on decreasing fatigue seems beneficial for patients with breast cancer with clinically relevant fatigue.

Screening for clinical insomnia in cancer patients with the Edmonton Symptom Assessment System-Revised: a specific sleep item is needed.

OBJECTIVE: We previously investigated the capacity of the original version of the Edmonton Symptom Assessment System-Revised (ESAS-r) and the Canadian Problem Checklist (CPP) to screen for clinical levels of insomnia in cancer patients. The original ESAS-r includes an item assessing drowsiness and an "other symptom" item, both of which are rated on a scale from 0 to 10, while the CPC has a sleep item, a box which is checked when this problem is present. Because none of these items showed an optimal screening capacity, we concluded that it would be best to add a specific 0-10 sleep item to the ESAS-r. This study assessed the capacity of this ESAS-r-sleep item to screen for clinical insomnia in patients with various cancer types. METHODS: A total of 392 patients with mixed cancer sites completed the ESAS-r as part of a routine screening procedure implemented in the radio-oncology department of L'Hôtel-Dieu de Québec (CHU de Québec-Université Laval). They also filled out the Insomnia Severity Index (ISI). RESULTS: Using a score of 8 or greater on the ISI as the standard criterion for clinical insomnia, a score of 2 or higher on the ESAS-r-sleep item (50.8% of the patients) was the one that showed the best screening indices: sensitivity of 86.7%, specificity of 75.3%, positive predictive value of 71.9%, and negative predictive value of 88.6%. An area under the curve of 0.89 was found, which is excellent. CONCLUSIONS: Adding a sleep item to the ESAS significantly improves screening of clinical insomnia in cancer patients.

Moderators of Cognitive Therapy and Bright Light Therapy Effects on Depressive Symptoms in Patients with Breast Cancer.

BACKGROUND: Cognitive therapy (CT) and bright light therapy (BLT) have been found to be effective to treat depressive symptoms in breast cancer patients. No study has investigated the baseline patients' characteristics that are associated with better outcomes with CT vs. BLT in this population. This study aimed to assess, in breast cancer patients, the moderating role of eight clinical variables on the effects of CT and BLT on depressive symptoms. METHODS: This is a secondary analysis of a randomized controlled trial conducted in 59 women who received an 8-week CT or BLT and completed questionnaires evaluating depression and possible moderating variables. RESULTS: Patients benefited more from BLT when they had no prior history of major depressive disorder, higher depression scores on the Hospital Anxiety and Depression Scale (HADS-D) at baseline, a greater initial preference for BLT, and when they received BLT during spring or summer. Patients benefited more from CT when they had a lower initial preference for receiving CT, higher depression scores on the HADS-D, and seasonal depressive symptoms. CONCLUSIONS: Although replication is needed, findings of this study suggest the existence of different profiles of patients more likely to benefit from CT and BLT. TRIAL REGISTRATION: NCT01637103 https://clinicaltrials.gov/ct2/show/NCT01637103.

Effects of concentrated long-chain omega-3 polyunsaturated fatty acid supplementation before radical prostatectomy on prostate cancer proliferation, inflammation, and quality of life: study protocol for a phase IIb, randomized, double-blind, placebo-controlled trial.

BACKGROUND: Prostate cancer is the most commonly diagnosed cancer in north-American men. Few dietary or lifestyle interventions have been tested to prevent prostate cancer progression. Omega-3 fatty acid supplementation represents a promising intervention for prostate cancer patients. The aim of the study is to evaluate the effects of long-chain omega-3 polyunsaturated fatty acids (LCn3), more precisely eicosapentaenoic acid monoacylglyceride (MAG-EPA) supplementation, on prostate cancer proliferation, inflammation mediators and quality of life among men who will undergo radical prostatectomy. METHODS/DESIGN: We propose a phase IIb, randomized, double-blind placebo-controlled trial of MAG-EPA supplementation for 130 men who will undergo radical prostatectomy as treatment for a prostate cancer of Gleason score ≥ 7 in an academic cancer center in Quebec City. Participants will be randomized to 6 capsules of 625 mg of fish oil (MAG-EPA) per capsule containing 500 mg of EPA daily or to identically looking capsules of high oleic acid sunflower oil (HOSO) as placebo. The intervention begins 4 to 10 weeks prior to radical prostatectomy (baseline) and continues for one year after surgery. The primary endpoint is the proliferative index (Ki-67) measured in prostate cancer cells at radical prostatectomy. A secondary endpoint includes prostate tissue levels of inflammatory mediators (cytokines and proteins) at time of radical prostatectomy. Changes in blood levels of inflammatory mediators, relative to baseline levels, at time of radical prostatectomy and 12 months after radical prostatectomy will also be evaluated. Secondary endpoints also include important aspects of psychosocial functioning and quality of life such as depression, anxiety, sleep disturbances, fatigue, cognitive complaints and prostate cancer-specific quality of life domains. The changes in these outcomes, relative to baseline levels, will be evaluated at 3, 6, 9 and 12 months after radical prostatectomy. DISCUSSION: The results from this trial will provide crucial information to clarify the role of omega-3 supplementation on prostate cancer proliferation, inflammation and quality of life. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02333435. Registered on December 17, 2014. Last updated September 6, 2016.

Utilization of health care services in cancer patients with elevated fear of cancer recurrence.

BACKGROUND: Cancer patients commonly report experiencing fear of cancer recurrence (FCR), which may lead to several negative consequences. This study aimed at examining whether clinical levels of FCR are linked to a greater use of health care services. METHOD: This is a secondary analysis of a longitudinal study of 962 cancer patients on the epidemiology of cancer-related insomnia. They completed the Fear of Cancer Recurrence Inventory-Short form (FCRI-SF) and reported information on their consultations (medical, psychosocial, and complementary and alternative medicine [CAM]) and medication usage (anxiolytics/hypnotics and antidepressants) at 6 time points over an 18-month period. RESULTS: Results indicated that clinical FCR at baseline was associated with greater consultation rates of medical and psychosocial professionals and a greater usage of anxiolytics/hypnotics and antidepressants. No significant association was found between the FCR level and use of CAM services. While consultation rates of medical and CAM professionals and usage of antidepressants generally increased over time, consultation rates of psychosocial professionals and usage of anxiolytics/hypnotics tended to decrease. CONCLUSIONS: Cancer patients with clinical levels of FCR are more likely to consult health care providers and to use psychotropic medications, which may translate into significant costs for society and the patients themselves.

Moderators of Treatment Effects of a Video-Based Cognitive-Behavioral Therapy for Insomnia Comorbid With Cancer.

PURPOSE: To assess the moderating role of demographic and clinical variables on the efficacy of a video-based cognitive behavioral therapy for insomnia (VCBT-I) among breast cancer patients. PATIENTS AND METHODS: As part of a randomized controlled trial, 80 women received VCBT-I. RESULTS: Patients with a more advanced breast cancer were less likely to show reductions on the Insomnia Severity Index (ISI) and increased sleep efficiency at posttreatment. Patients using an antidepressant medication showed a larger reduction of ISI scores and a higher rate of insomnia remission. Remission of insomnia was also significantly more likely in individuals with a higher annual income. When using a multivariate binary classification tree analysis, the best and unique predictor of insomnia remission was having a less severe baseline ISI score. CONCLUSION: Although efficacious in general, VCBT-I does not appear to be an optimal format for everybody.

Sleep-wake difficulties in community-dwelling cancer patients receiving palliative care: subjective and objective assessment.

OBJECTIVE: Prevalence rates of sleep difficulties in advanced cancer patients have varied widely across studies (12 to 96%), and none of these employed a diagnostic interview to distinguish different types of sleep-wake disorders. Moreover, very limited information is available on subjective and objective sleep parameters in this population. Our study was conducted in palliative cancer patients and aimed to assess rates of sleep-wake disorders and subsyndromal symptoms and to document subjective and objective sleep-wake parameters across various types of sleep-wake difficulties. METHOD: The sample was composed of 51 community-dwelling cancer patients receiving palliative care and having an Eastern Cooperative Oncology Group score of 2 or 3. Relevant sections of the Duke Interview for Sleep Disorders were administered over the phone. An actigraphic recording and a daily sleep diary were completed for 7 consecutive days. RESULTS: Overall, 68.6% of the sample had at least one type of sleep-wake difficulty (disorder or symptoms): 31.4% had insomnia and 29.4% had hypersomnolence as their main sleep-wake problem. Participants with insomnia as their main sleep difficulty had greater disruptions of subjective sleep parameters, while objectively-assessed sleep was more disrupted in patients with hypersomnolence comorbid with another sleep-wake difficulty.Significance of the Results:The high rates of sleep-wake difficulties found in this study indicate a need to screen more systematically for sleep-wake disorders, including insomnia and hypersomnolence, in both palliative care research and clinical practice, and to develop effective nonpharmacological interventions specifically adapted to this population.

Predictors of Smoking Cessation and Relapse in Cancer Patients and Effect on Psychological Variables: an 18-Month Observational Study.

BACKGROUND: Although cancer patients are generally strongly advised to quit smoking in order to improve treatment efficacy and survival, up to 68 % of patients who were smokers at the time of cancer diagnosis continue smoking. Psychological factors such as depression and anxiety are likely to be associated with smoking behavior following a cancer diagnosis, but the empirical evidence is scarce. PURPOSE: This observational study aimed at estimating smoking cessation rates and assessing the effect of smoking cessation on psychological symptoms, as well as the predictive role of the same psychological variables on smoking cessation and smoking relapse following cancer surgery. METHODS: As part of a larger prospective, epidemiological study, smokers (n = 175) with a first diagnosis of nonmetastatic cancer completed the Hospital Anxiety and Depression Scale, the Insomnia Severity Index, and the Fear of Cancer Recurrence Inventory. Quitters (n = 55) and pair-matched nonquitters (n = 55) were compared on each symptom at pre-quitting, post-quitting, and at a 4-month follow-up. Predictors of smoking cessation and smoking relapse, including psychological variables, were also investigated. RESULTS: Fifty-five patients (31.4 %) stopped smoking at least on one occasion during the study. Of the 55 quitters, 27 (49.1 %) experienced a relapse. At pre-quitting, quitters had significantly higher levels of anxiety (p = .03) and fear of cancer recurrence (p = .01) than nonquitters, symptoms that significantly diminished at post-quitting and 4 months later in this subgroup of patients. Having breast cancer significantly predicted smoking cessation (relative risk [RR] = 3.08), while depressive symptoms were a significant predictor of smoking relapse (RR = 1.07). CONCLUSIONS: This study highlights the importance of psychological symptoms in predicting tobacco cessation and relapse among individuals with cancer. Our findings suggest that breast cancer patients are more inclined to stop smoking than patients with other cancers, but future studies should attempt to delineate the effect on smoking cessation of gender and other demographics that characterize this subgroup. This study also suggests that a particular attention should be paid to the early management of depressive symptoms in order to prevent smoking relapse.