Time Toxicity Experienced by Early-Phase Cancer Clinical Trial Participants.

PURPOSE: Early-phase clinical trials (EP-CTs) are designed to determine optimal dosing, tolerability, and preliminary activity of novel cancer therapeutics. Little is known about the time that patients spend interacting with the health care system (eg, time toxicity) while participating in these studies. METHODS: We retrospectively reviewed the electronic health records of consecutive patients enrolled in EP-CTs from 2017 to 2019 to obtain baseline characteristics and number of health care-associated days, defined as all inpatient and outpatient visits while on trial. We used univariable and multivariable analyses to identify predictors of increased time toxicity, defined as the proportion of health care-associated days among total days on trial. For ease of interpretation, we created a dichotomous variable, with high time toxicity defined as ≥20% health care-associated days during time on trial and used regression models to evaluate relationships between time toxicity and clinical outcomes. RESULTS: Among 408 EP-CT participants (mean age, 60.5 years [standard deviation, SD, 12.6]; 56.5% female; 88.2% White; 96.0% non-Hispanic), patients had an average of 22.5% health care-associated days while on trial (SD, 13.8%). Those with GI (B = 0.07; P = .002), head/neck (B = 0.09; P = .004), and breast (B = 0.06; P = .015) cancers and those with worse performance status (B = 0.04; P = .017) and those receiving targeted therapies (B = 0.04; P = .014) experienced higher time toxicity. High time toxicity was associated with decreased disease response rates (odds ratio, 0.07; P < .001), progression-free survival (hazard ratio [HR], 2.10; P < .001), and overall survival (HR, 2.16; P < .001). CONCLUSION: In this cohort of EP-CT participants, patients spent more than one-fifth of days on trial with health care contact. We identified characteristics associated with higher time toxicity and found that high toxicity correlated with worse clinical outcomes. These data could help inform patient-clinician discussions about EP-CTs, guide future trial design, and identify at-risk patients.

Palliative Care for Patients With Cancer: ASCO Guideline Update.

PURPOSE: To provide evidence-based guidance to oncology clinicians, patients, nonprofessional caregivers, and palliative care clinicians to update the 2016 ASCO guideline on the integration of palliative care into standard oncology for all patients diagnosed with cancer. METHODS: ASCO convened an Expert Panel of medical, radiation, hematology-oncology, oncology nursing, palliative care, social work, ethics, advocacy, and psycho-oncology experts. The Panel conducted a literature search, including systematic reviews, meta-analyses, and randomized controlled trials published from 2015-2023. Outcomes of interest included quality of life (QOL), patient satisfaction, physical and psychological symptoms, survival, and caregiver burden. Expert Panel members used available evidence and informal consensus to develop evidence-based guideline recommendations. RESULTS: The literature search identified 52 relevant studies to inform the evidence base for this guideline. RECOMMENDATIONS: Evidence-based recommendations address the integration of palliative care in oncology. Oncology clinicians should refer patients with advanced solid tumors and hematologic malignancies to specialized interdisciplinary palliative care teams that provide outpatient and inpatient care beginning early in the course of the disease, alongside active treatment of their cancer. For patients with cancer with unaddressed physical, psychosocial, or spiritual distress, cancer care programs should provide dedicated specialist palliative care services complementing existing or emerging supportive care interventions. Oncology clinicians from across the interdisciplinary cancer care team may refer the caregivers (eg, family, chosen family, and friends) of patients with cancer to palliative care teams for additional support. The Expert Panel suggests early palliative care involvement, especially for patients with uncontrolled symptoms and QOL concerns. Clinicians caring for patients with solid tumors on phase I cancer trials may also refer them to specialist palliative care.Additional information is available at www.asco.org/supportive-care-guidelines.

Identifying Early-Phase Clinical Trial Participants at Risk for Experiencing Worse Clinical Outcomes.

PURPOSE: To identify early-phase clinical trial (EP-CT) participants at risk for experiencing worse clinical outcomes and describe receipt of supportive care services. METHODS: A retrospective review of the electronic health records of consecutive patients enrolled in EP-CTs from 2017 to 2019 examined baseline characteristics, clinical outcomes, and receipt of supportive care services. The validated Royal Marsden Hospital (RMH) prognosis score was calculated using data at the time of EP-CT enrollment (scores range from 0 to 3; scores ≥ 2 indicate poor prognosis). Differences in patient characteristics, clinical outcomes, and receipt of supportive care services were compared on the basis of RMH scores. RESULTS: Among 350 patients (median age = 63.2 years [range, 23.0-84.3 years], 57.1% female, 98.0% metastatic cancer), 31.7% had an RMH score indicating a poor prognosis. Those with poor prognosis RMH scores had worse overall survival (hazard ratio [HR], 2.00; P < .001), shorter time on trial (HR, 1.53; P < .001), and lower likelihood of completing the dose-limiting toxicity period (odds ratio, 0.42; P = .006) versus those with good prognosis scores. Patients with poor prognosis scores had greater risk of emergency room visits (HR, 1.66; P = .037) and hospitalizations (HR, 1.69; P = .016) while on trial, and earlier hospice enrollment (HR, 2.22; P = .006). Patients with poor prognosis scores were significantly more likely to receive palliative care consultation (46.8% v 27.6%; P < .001), but not other supportive care services. CONCLUSION: This study found that RMH prognosis score could identify patients at risk for decreased survival, shorter time on trial, and greater use of health care services. The findings underscore the need to develop supportive care interventions targeting EP-CT participants' distinct needs.

I'm Still Mom: Young Mothers Living With Advanced Breast Cancer.

PURPOSE: To conduct a detailed content analysis of the theme "I'm still Mom" as described by young women living with advanced breast cancer. PARTICIPANTS & SETTING: 12 young adult women living with advanced breast cancer were recruited from across the United States. METHODOLOGIC APPROACH: van Manen's hermeneutic phenomenologic method was used to analyze qualitative data from interviews and establish subthemes. FINDINGS: Women were a mean age of 36 years and had at least one child. The following three subthemes emerged from the overarching theme of I'm still Mom. IMPLICATIONS FOR NURSING: This study provides a foundation for additional research that can inform family-centered education and interventions to help align the parenting priorities of this cohort of women, as well as optimize their quality of life.

Cutaneous Metastases: A Case Study on Clinical Care for Patients.

Cutaneous metastases (CMs) signal the spread of a primary tumor to the skin and dermis, particularly in patients with melanoma or with breast, lung, or gastrointestinal cancers. Although these lesions may present as superficial and painless, some CMs may lead to ulceration, drainage, and discomfort, causing distress to patients. Oncology nurses require knowledge about the clinical presentation of CMs, including incidence, pathophysiology, diagnostic evaluation, and complex symptomatology, as well as standard treatment and care for patients. In addition, nurses can provide psychosocial interventions to assist patients experiencing distress from CM lesions.

Experiences of Adolescents and Young Adults Living With Advanced Cancer: An Integrative Review.

PROBLEM IDENTIFICATION: Knowledge about the experiences of adolescents and young adults (AYAs) living with advanced cancer may be limited. This review was conducted to examine the literature concerning this subject. LITERATURE SEARCH: A comprehensive search was conducted using CINAHL®, the Cochrane Library of Systematic Reviews, Embase®, the Joanna Briggs Institute (JBI), and PubMed®. DATA EVALUATION: Each study was systematically assessed. An evidence table detailing key components was compiled. SYNTHESIS: There is a growing body of knowledge about the experiences of individuals with advanced cancer. However, insufficient evidence exists regarding the experiences of AYAs with advanced cancer. IMPLICATIONS FOR RESEARCH: The lack of knowledge about AYAs and how they experience living with advanced cancer requires additional research; this will lead to increased understanding of their challenges and more effective supportive interventions.

Wearing the Mask of Wellness: The Experience of Young Women Living With Advanced Breast Cancer.

PURPOSE: To describe and interpret the lived experiences of young women with advanced breast cancer. PARTICIPANTS & SETTING: 12 women, aged 25-39 years with advanced breast cancer, were recruited from private Facebook groups for women with breast cancer. METHODOLOGIC APPROACH: Van Manen's hermeneutic phenomenologic method was used. Data were collected through one or more semi-structured interviews over a six-month period. Analysis was conducted using NVivo, version 11. FINDINGS: The participants' multidimensional experiences were described by the overarching theme of wearing the mask of wellness in the presence of life-threatening illness. IMPLICATIONS FOR NURSING: This study provides insight into the experiences of young women living with advanced breast cancer. Because these women may not appear ill to the general population, their needs and struggles are not well understood. The results of this study can be a baseline for additional research and clinical interventions.

A state-wide initiative to promote genetic testing in an underserved population.

Genetic testing for cancer susceptibility has been widely studied and utilized clinically. Access to genetic services in research and practice is largely limited to well-insured, Caucasian individuals. In 2009, the Cancer Resource Foundation (CRF) implemented the Genetic Information for Treatment Surveillance and Support (GIFTSS) program to cover the out-of-pocket expenses associated with cancer genetic testing, targeting high-risk individuals with limited financial means and limited health insurance coverage. Here, we (i) describe the characteristics of participants in the Massachusetts (MA) GIFTSS program and (ii) evaluate mutations found in this diverse sample. A secondary retrospective data analysis was performed using de-identified demographic data obtained from laboratory requisition forms and cancer genetic testing result information from the laboratory source. Eligible participants were those who utilized the MA GIFFTS program from 2009 through December of 2014. Data were summarized using descriptive measures of central tendency. Participants were residents of Massachusetts who had health insurance and had a reported income within 250-400% of the federal poverty level. Genetic testing results were categorized following clinical guidelines. Overall, 123 (13%) of participants tested positive for a mutation in a cancer susceptibility gene. For those with a cancer diagnosis, 65 (12%) were found to have a positive result and 20 (7%) had a variant of uncertain significance (VUS). For those unaffected patients, 58 (15%) had a positive result and 10 (3%) were found to have a VUS. The results from this study are useful in describing genetic testing outcomes in this high-risk underserved community. Repeatedly, the literature reports that individuals from diverse or limited resource settings are less likely to access genetic testing. Continued research efforts should be devoted to promoting the access of genetic testing in the high-risk, underserved community.

The Feasibility, Safety, and Efficacy of Using a Wireless Pedometer to Improve the Activity Level in a Cohort of Nurses.

PURPOSE: This study had two aims: (1) to test the feasibility, safety, and efficacy of using a wireless pedometer in a cohort of nurses; and (2) to understand if wireless pedometer use increased number of steps walked, number of flights of stairs climbed, daily activity level, and improved personal perception of health. DESIGN: This study used a nonexperimental exploratory design to test the feasibility and efficacy of using a wireless pedometer in a cohort of nurses. Pre- and posttest measures captured the number of steps walked, flights of stairs climbed, activity level, and perception of health. RESULTS: Sample characteristics: 27 females, 3 males; 90% non-Hispanic Caucasian, 3% Hispanic; 47% between the ages of 55 and 65 years. Eighty percent of the participants reported that they were caregivers of other people. There was a significant increase from baseline to the end of the study in the following measures: self-perception of steps walked ( p < .001), flights of stairs climbed ( p < .005), self-perception of daily activity ( p < .001), and although there was an improvement in self-perception of health, the change was not significant. CONCLUSIONS: The wireless pedometer was a feasible, safe, and efficacious device to use. This study may have implications for interventions aimed at improving caregiver health.