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.

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.