Management of Insomnia in Breast Cancer Patients (Currently Recruiting)

Sleep disturbance, particularly insomnia, is prevalent in cancer patients undergoing chemotherapy. Our preliminary data show that our novel intervention, Brief Behavioral Therapy for Insomnia (BBT-I), significantly reduces insomnia in breast cancer patients receiving chemotherapy. BBT-I is modeled on standard cognitive behavioral therapy for insomnia (CBT-I), including both stimulus control and sleep scheduling, and has been successfully modified to make it more suitable for breast cancer patients undergoing adjuvant or neoadjuvant chemotherapy with recently developed insomnia symptoms. Our preliminary research suggests that BBT-I is an acceptable and feasible intervention for insomnia in breast cancer patients that might also lead to improvement in fatigue and cognitive difficulties.

This research is designed to determine the efficacy of the BBT-I in comparison with the attention-matched behavioral control in reducing insomnia, fatigue, and cognitive difficulties in breast cancer patients. In addition, this study will examine the potential involvement of moderators (age, depression, anxiety, and hot flashes), specific behavioral mechanisms (maladaptive sleep behaviors, dysfunctional beliefs and attitudes), and physiological mechanisms (dysregulated circadian rhythms, disrupted wake-sleep cycles, and autonomic tone) as potential mediators of intervention-related changes in insomnia and the secondary outcomes of fatigue and cognitive difficulties. To address these aims, 180 breast cancer patients with acute insomnia during chemotherapy treatment will be recruited and randomized to receive either BBT-I or a behavioral control focused on Healthy Eating Education. Each intervention condition will consist of 2 face-to-face sessions + 4 phone calls, delivered over a period of six weeks. Assessments will include sleep diary, questionnaires, neuropsychological testing, actigraphy, heart rate variability measurement, and salivary cortisol collection at baseline, post-intervention, and 6- and 12 months follow ups. By offering this intervention during chemotherapy when patients are just beginning to develop insomnia, we hope to alleviate and avoid the development of chronic insomnia in the survivorship phase.

Funded by the National Cancer Institute. #5R01CA181659-02

Prefrontal Cortex Abnormalities Associated With Breast Cancer Chemotherapy (Currently Recruiting)

Our laboratory, as well as others, has demonstrated abnormalities in brain structure and function associated with breast cancer chemotherapy, most consistently in the prefrontal cortex. The prefrontal cortex is critical for skills such as multi-tasking, attention, processing speed and memory; skills that are often impaired in patients who have undergone breast cancer chemotherapy. Because prefrontal cortex changes have also been observed in patients prior to chemotherapy treatment as well as in those treated with radiation and/or hormonal blockade, the specific effects of chemotherapy on prefrontal cortex remain unclear. It is also currently unknown why some patients treated with chemotherapy show improvement in cognitive function over time while others do not. The proposed research will examine prefrontal cortex structure and function as well as cognitive status in 50 patients with primary breast cancer scheduled for chemotherapy. These patients will be evaluated across the treatment course, from pre-surgery to 12 months post-chemotherapy. We will compare the chemotherapy-treated group to 50 patients who do not receive chemotherapy and to 50 healthy females who are all assessed at the same time intervals as the chemotherapy-treated group. We will utilize non-invasive neuroimaging (MRI) methods to measure prefrontal cortex volume and functional activation in combination with neuropsychological measures of executive function, memory, processing speed and attention. We will also explore possible predictors of individual outcome such as demographic, disease, psychiatric and treatment factors. Increasing our understanding regarding the neurobiologic mechanisms underlying chemotherapy-related cognitive impairments may improve identification of patients at highest risk for cognitive deficit and aid the development of treatments for these impairments.

Funded by the National Cancer Institute. #5R01CA172145-04

Better Sleep for BMT (Recruiting Completed)

Sleep disturbance in the BMT population has been described in a small number of studies, typically noted in conjunction with reporting quality of life and/or fatigue post-BMT. A similar finding to cancer patients receiving standard chemotherapy, BMT recipients have a greater incidence of sleep disturbance than the normal population. However, the sleep disturbance persisted in approximately a third of patients 3 months to several years post-BMT. In addition, reports note a statistically significant correlation between fatigue and sleep disturbance in the post-BMT patient. Although one study suggests Cognitive Behavior Therapy to manage post-BMT fatigue, none of these studies investigated interventions to alleviate fatigue or sleep disturbance.

Behavioral intervention may be an effective approach to reducing insomnia in cancer patients during and following therapy, suggested by two pilot studies completed by Dr. Palesh. Based on this preliminary information and the multidisciplinary collaboration between a cancer behavioral scientist (Dr. Palesh), a BMT clinical researcher (Dr. Johnston) and a neuroscientist (Dr. Kesler), an open label, single arm clinical trial in BMT recipients is proposed. This team brings a unique expertise in all 3 clinical areas allowing the investigation of behavioral therapy for BMT recipients with sleep disturbance. The expected accrual is 40 patients over one year, with all eligible BMT patients receiving the brief behavioral intervention (BBT-I). The BBT-I is modeled on standard cognitive behavioral therapy for insomnia (CBT-I) and includes both stimulus control and sleep scheduling, modified to make it more suitable for cancer patients with recently developed insomnia symptoms.

Assessment of Symptoms and Side Effects in Pancreatic Adenocarcinoma Patients (Recruiting Completed)

Patients diagnosed with pancreatic adenocarcinoma suffer from multiple side effects of their cancer and cancer treatments. Relatively little is known about the supportive care needs of this population, and when those needs can be most effectively addressed. In order to eventually conduct a randomized control trial of early supportive care in this population, and in order to most effectively implement supportive care with limited resources, we aim to better understand the symptomatic needs over time of the Stanford Cancer Center pancreatic adenocarcinoma patients.

Patients receiving treatment at the Stanford Cancer Center will be assessed for presence of side effects as measured by a symptom inventory survey originally developed for this study based on MD Anderson Symptom Inventory and adapted through focus groups of pancreatic cancer patients, their medical providers, and our team for medical and psychiatric symptomatology and treatments. We expect to recruit 80 participants for this study.

Acupuncture for Sleep Disruption in Cancer Survivors (Recruiting Completed)

Acupuncture is well known to be effective as a pain treatment, but several recent studies have examined its efficacy for insomnia. Three recent reviews of randomized controlled trials concluded that acupuncture may have a beneficial effect on subjective measures of sleep, but also highlight methodological limitations quality of extant research. Among the methodological issues identified by the recent reviews are: imprecise diagnostic procedures, problems with randomization, blinding issues, and insufficient safety data. We propose to address these methodological concerns using individualized acupuncture treatments.

Currently, there are no studies on the efficacy of needle acupuncture for insomnia in cancer patients. The mechanism by which it is presumed to promote sleep is by stimulating the release of neurotransmitters involved in the sleep-wake system or through its effects on melatonin secretion. This study enrolled 64 women with breast cancer from the Stanford Cancer Center and local communities who finished undergoing treatment and who complain of persistent insomnia problems. The eligible women with sleep disruption were randomized into one of two arms: Acupuncture vs. Sham Acupuncture.