Using Music as a Tool for Distress Reduction During Cancer Chemotherapy Treatment.

PURPOSE: Music may be an effective therapeutic tool during cancer treatment to improve patient psychological and physical well-being. Current research shows a positive effect of music on psychological outcomes; however, many of these studies lacked significant sample size and rigor in monitoring type of music used and duration of music use during treatment. METHODS: Participants (N = 750) in this open-label, multisite, day-based permuted block randomization study were adult patients receiving outpatient chemotherapy infusion. Patients were randomly assigned to either music (listen to music for up to 60 minutes) or control (no music) conditions. Music patients were allowed to self-select an iPod shuffle programmed with up to 500 minutes of music from a single genre (eg, Motown, 60s, 70s, 80s, classical, and country). Outcomes were self-reported change in pain, positive and negative mood, and distress. RESULTS: Patients who listened to self-selected music during infusion showed significant benefit in improved positive mood and reduced negative mood and distress (but not pain) from pre- to post-intervention (all two-sample t-tests P < .05). LASSO penalized linear regression models showed a selective benefit for some patients on the basis of relationship (P = .032) and employment (P = .029) status with those who were married or widowed and those on disability showing better outcomes. CONCLUSION: Music medicine is a low-touch, low-risk, and cost-effective way to manage patients' psychological well-being in the often stressful context of a cancer infusion clinic. Future research should be directed to understanding what other factors may mitigate negative mood states and pain for certain groups during treatment.

Immune Checkpoint Inhibitor-induced Pneumonitis: Incidence, Clinical Characteristics, and Outcomes.

BACKGROUND: Immune checkpoint inhibitors (ICIs) are the newest class of anticancer drugs. Pneumonitis is increasingly being recognized as a potential complication of these agents. METHODS: We conducted a retrospective study of patients who received ICIs at a comprehensive cancer center. We collected data on demographics, type of malignancy, type of ICI agent, incidence of pneumonitis up to 6 weeks after receiving ICI agent, clinical characteristics, and risk factors for overall survival in patients who develop pneumonitis. RESULTS: A total of 654 patients received ICIs during the study period. The most common type of cancer for which ICI was given was adenocarcinoma of the lung (29%), followed by renal cell cancer (12%) and squamous cell lung cancer (12%). Among the study patients, 41% received nivolumab and 32% received pembrolizumab. Other patients in the study received combination of ICIs or ICI plus chemotherapeutic agent, or were part of clinical trial involving ICI. Overall 42 (6.4%) patients developed pneumonitis within 6 weeks after the last dose of treatment of any ICI agent. Of these, 81% of patients had Grade ≥ 2 pneumonitis and 45% of these required hospital admission for pneumonitis, with 10% of them requiring admission to intensive care unit. Overall, patients who received pembrolizumab-containing regimen, had prior chemotherapy, or who never had cancer-related surgery had increased risk of death. CONCLUSION: Our large retrospective study shows real-life data of incidence of pneumonitis in patients who are treated with ICIs for cancer treatment. Our data indicate that the incidence of pneumonitis is overall lower than that reported previously with relatively good outcomes.

Addressing multilevel barriers to clinical trial participation among Black and White men with prostate cancer through the PACCT study.

BACKGROUND: Cancer clinical trial participation is low and inequitable. Partnering Around Cancer Clinical Trials (PACCT) addressed systemic and interpersonal barriers through an observational study of eligibility and an intervention to improve patient-physician communication and trial invitation rates. METHODS: Physicians at two comprehensive cancer centers and Black and White men with prostate cancer participated. Patients were followed for 2 years to determine whether they became potentially eligible for an available therapeutic trial. Potentially eligible patients were randomized to receive a trials-focused Question Prompt List or usual care. Patient-physician interactions were video-recorded. Outcomes included communication quality and trial invitation rates. Descriptive analyses assessed associations between sociodemographic characteristics and eligibility and effects of the intervention on outcomes. RESULTS: Only 44 (22.1%) of participating patients (n = 199) became potentially eligible for an available clinical trial. Patients with higher incomes were more often eligible (>$80,000 vs. <$40,000, adjusted OR = 6.06 [SD, 1.97]; $40,000-$79,000 vs. <$40,000, adjusted OR = 4.40 [SD, 1.81]). Among eligible patients randomized to the intervention (n = 19) or usual care (n = 25), Black patients randomized to the intervention reported participating more actively than usual care patients, while White intervention patients reported participating less actively (difference, 0.41 vs. -0.34). Intervention patients received more trial invitations than usual care patients (73.7% vs. 60.0%); this effect was greater for Black (80.0% vs. 30.0%) than White patients (80.0% vs. 66.7%). CONCLUSIONS: Findings suggest the greatest enrollment barrier is eligibility for an available trial, but a communication intervention can improve communication quality and trial invitation rates, especially for eligible Black patients.

DISCO App: study protocol for a randomized controlled trial to test the effectiveness of a patient intervention to reduce the financial burden of cancer in a diverse patient population.

BACKGROUND: Financial toxicity, the material and psychological burden of the cost of treatment, affects 30-50% of people with cancer, even those with health insurance. The burden of treatment cost can affect treatment adherence and, ultimately, mortality. Financial toxicity is a health equity issue, disproportionately affecting patients who are racial/ethnic minorities, have lower incomes, and are < 65 years old. Patient education about treatment cost and patient-oncologist cost discussions are recommended as ways to address financial toxicity; however, research shows cost discussions occur infrequently (Altice et al. J Natl Cancer Inst 109:djw205, 2017; Schnipper et al. J Clin Oncol 34:2925-34, 2016; Zafar et al. Oncologist 18:381-90, 2013; American Cancer Society Cancer Action Network 2010). Our overall goal is to address the burden of financial toxicity and work toward health equity through a tailorable education and communication intervention, the DISCO App. The aim of this longitudinal randomized controlled trial is to test the effectiveness of the DISCO App on the outcomes in a population of economically and racially/ethnically diverse cancer patients from all age groups. METHODS: Patients diagnosed with breast, lung, colorectal, or prostate cancer at a NCI-designated comprehensive cancer center in Detroit, MI, will be randomized to one of three study arms: one usual care arm (arm 1) and two intervention arms (arms 2 and 3). All intervention patients (arms 2 and 3) will receive the DISCO App before the second interaction with their oncologist, and patients in arm 3 will receive an intervention booster. The DISCO App, presented on an iPad, includes an educational video about treatment costs, ways to manage them, and the importance of discussing them with oncologists. Patients enter socio-demographic information (e.g., employment, insurance status) and indicate their financial concerns. They then receive a tailored list of questions to consider asking their oncologist. All patients will have up to two interactions with their oncologist video recorded and complete measures at baseline, after the recorded interactions and at 1, 3, 6, and 12 months after the second interaction. Outcome measures will assess discussions of cost, communication quality, knowledge of treatment costs, self-efficacy for treatment cost management, referrals for support, short- and longer-term financial toxicity, and treatment adherence. DISCUSSION: If effective, this intervention will improve awareness of and discussions of treatment cost and alleviate the burden of financial toxicity. It may be especially helpful to groups disproportionately affected by financial toxicity, helping to achieve health equity. TRIAL REGISTRATION: ClinicalTrials.gov NCT04766190. Registered on February 23, 2021.

Willingness to Discuss Clinical Trials Among Black vs White Men With Prostate Cancer.

IMPORTANCE: Black individuals are underrepresented in cancer clinical trials. OBJECTIVE: To examine whether Black and White men with prostate cancer differ in their willingness to discuss clinical trials with their physicians and, if so, whether patient-level barriers statistically mediate racial differences. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional survey study used baseline data from Partnering Around Cancer Clinical Trials, a randomized clinical trial to increase Black individuals' enrollment in prostate cancer clinical trials. Data were collected from 2016 through 2019 at 2 National Cancer Institute-designated comprehensive cancer centers; participants were Black and White men with intermediate-risk to high-risk prostate cancer. In mediation analysis, path models regressed willingness onto race and each potential mediator, simultaneously including direct paths from race to each mediator. Significant indirect effect sizes served as evidence for mediation. EXPOSURES: Race was the primary exposure. Potential mediators included age, education, household income, perceived economic burden, pain/physical limitation, health literacy, general trust in physicians, and group-based medical suspicion. MAIN OUTCOMES AND MEASURES: The primary outcome was the answer to a single question: "If you were offered a cancer clinical trial, would you be willing to hear more information about it?" RESULTS: A total of 205 participants were included (92 Black men and 113 White men), with a mean (range) age of 65.7 (45-89) years; 32% had a high school education or lower, and 27.5% had a household income of less than $40 000. Most (88.3%) reported being definitely or probably willing to discuss trials, but White participants were more likely to endorse this highest category of willingness than Black participants (82% vs 64%; χ22 = 8.81; P = .01). Compared with White participants, Black participants were younger (F1,182 = 8.67; P < .001), less educated (F1,182 = 22.79; P < .001), with lower income (F1,182 = 79.59; P < .001), greater perceived economic burden (F1,182 = 42.46; P < .001), lower health literacy (F1,184 = 9.84; P = .002), and greater group-based medical suspicion (F1,184 = 21.48; P < .001). Only group-based medical suspicion significantly mediated the association between race and willingness to discuss trials (indirect effect, -0.22; P = .002). CONCLUSIONS AND RELEVANCE: In this study of men with prostate cancer, most participants were willing to discuss trials, but Black men were significantly less willing than White men. Black men were more likely to believe that members of their racial group should be suspicious of the health care system, and this belief was associated with lower willingness to discuss trials. Addressing medical mistrust may improve equity in clinical research.

Partnering around cancer clinical trials (PACCT): study protocol for a randomized trial of a patient and physician communication intervention to increase minority accrual to prostate cancer clinical trials.

BACKGROUND: Cancer clinical trials are essential for testing new treatments and represent state-of-the-art cancer treatment, but only a small percentage of patients ever enroll in a trial. Under-enrollment is an even greater problem among minorities, particularly African Americans, representing a racial/ethnic disparity in cancer care. One understudied cause is patient-physician communication, which is often of poor quality during clinical interactions between African-American patients and non-African-American physicians. Partnering Around Cancer Clinical Trials (PACCT) involves a transdisciplinary theoretical model proposing that patient and physician individual attitudes and beliefs and their interpersonal communication during racially discordant clinical interactions influence outcomes related to patients' decisions to participate in a trial. The overall goal of the study is to test a multilevel intervention designed to increase rates at which African-American and White men with prostate cancer make an informed decision to participate in a clinical trial. METHODS/DESIGN: Data collection will occur at two NCI-designated comprehensive cancer centers. Participants include physicians who treat men with prostate cancer and their African-American and White patients who are potentially eligible for a clinical trial. The study uses two distinct research designs to evaluate the effects of two behavioral interventions, one focused on patients and the other on physicians. The primary goal is to increase the number of patients who decide to enroll in a trial; secondary goals include increasing rates of physician trial offers, improving the quality of patient-physician communication during video recorded clinical interactions in which trials may be discussed, improving patients' understanding of trials offered, and increasing the number of patients who actually enroll. Aims are to 1) determine the independent and combined effects of the two interventions on outcomes; 2) compare the effects of the interventions on African-American versus White men; and 3) examine the extent to which patient-physician communication mediates the effect of the interventions on the outcomes. DISCUSSION: PACCT has the potential to identify ways to increase clinical trial rates in a diverse patient population. The research can also improve access to high quality clinical care for African American men bearing the disproportionate burden of disparities in prostate and other cancers. TRIAL REGISTRATION: Clinical Trials.gov registration number: NCT02906241 (September 8, 2016).

Neurotization from two medial pectoral nerves to musculocutaneous nerve in a pediatric brachial plexus injury.

Traumatic brachial plexus injuries can be devastating, causing partial to total denervation of the muscles of the upper extremities. Surgical reconstruction can restore motor and/or sensory function following nerve injuries. Direct nerve-to-nerve transfers can provide a closer nerve source to the target muscle, thereby enhancing the quality and rate of recovery. Restoration of elbow flexion is the primary goal for patients with brachial plexus injuries. A 4-year-old right-hand-dominant male sustained a fracture of the left scapula in a car accident. He was treated conservatively. After the accident, he presented with motor weakness of the left upper extremity. Shoulder abduction was grade 3 and elbow flexor was grade 0. Hand function was intact. Nerve conduction studies and an electromyogram were performed, which revealed left lateral and posterior cord brachial plexopathy with axonotmesis. He was admitted to Rehabilitation Medicine and treated. However, marked neurological dysfunction in the left upper extremity was still observed. Six months after trauma, under general anesthesia with the patient in the supine position, the brachial plexus was explored through infraclavicular and supraclavicular incisions. Each terminal branch was confirmed by electrophysiology. Avulsion of the C5 roots and absence of usable stump proximally were confirmed intraoperatively. Under a microscope, neurotization from the musculocutaneous nerve to two medial pectoral nerves was performed with nylon 8-0. Physical treatment and electrostimulation started 2 weeks postoperatively. At a 3-month postoperative visit, evidence of reinnervation of the elbow flexors was observed. At his last follow-up, 2 years following trauma, the patient had recovered Medical Research Council (MRC) grade 4+ elbow flexors. We propose that neurotization from medial pectoral nerves to musculocutaneous nerve can be used successfully to restore elbow flexion in patients with brachial plexus injuries.

Dynamic levels of glutamate within the insula are associated with improvements in multiple pain domains in fibromyalgia.

OBJECTIVE: Fibromyalgia (FM) is a chronic widespread pain condition that is thought to arise from augmentation of central neural activity. Glutamate (Glu) is an excitatory neurotransmitter that functions in pain-processing pathways. This study was carried out to investigate the relationship between changing levels of Glu within the insula and changes in multiple pain domains in patients with FM. METHODS: Ten patients with FM underwent 2 sessions of proton magnetic resonance spectroscopy (H-MRS) and 2 sessions of functional magnetic resonance imaging (FMRI), each conducted before and after a nonpharmacologic intervention to reduce pain. During H-MRS, the anterior and posterior insular regions were examined separately using single-voxel spectroscopy. The levels of Glu and other metabolites were estimated relative to levels of creatine (Cr) (e.g., the Glu/Cr ratio). During FMRI, painful pressures were applied to the thumbnail to elicit neuronal activation. Experimental pressure-evoked pain thresholds and clinical pain ratings (on the Short Form of the McGill Pain Questionnaire [SF-MPQ]) were also assessed prior to each imaging session RESULTS: Both experimental pain (P = 0.047 versus pretreatment) and SF-MPQ-rated clinical pain (P = 0.043 versus pretreatment) were reduced following treatment. Changes from pre- to posttreatment in Glu/Cr were negatively correlated with changes in experimental pain thresholds (r = -0.95, P < 0.001) and positively correlated with changes in clinical pain (r = 0.85, P = 0.002). Changes in the FMRI-determined blood oxygenation level-dependent effect (a measure of neural activation) were positively correlated with changes in Glu/Cr within the contralateral insula (r = 0.81, P = 0.002). CONCLUSION: Changes in Glu levels within the insula are associated with changes in multiple pain domains in patients with FM. Thus, H-MRS data may serve as a useful biomarker and surrogate end point for clinical trials of FM.