Advancing Clinical Trial Design for Non-Muscle Invasive Bladder Cancer.

BACKGROUND: Despite recent drug development for non-muscle invasive bladder cancer (NMIBC), few therapies have been approved by the US Food and Drug Administration (FDA), and there remains an unmet clinical need. Bacillus Calmette-Guerin (BCG) supply issues underscore the importance of developing safe and effective drugs for NMIBC. OBJECTIVE: On November 18-19, 2021, the FDA held a public virtual workshop to discuss NMIBC research needs and potential trial designs for future development of effective therapies. METHODS: Representatives from various disciplines including urologists, oncologists, pathologists, statisticians, basic and translational scientists, and the patient advocacy community participated. The workshop format included invited lectures, panel discussions, and opportunity for audience discussion and comment. RESULTS: In a pre-workshop survey, 92% of urologists surveyed considered the development of alternatives to BCG as a high drug development priority for BCG-naïve high-risk patients. Key topics discussed included definitions of disease states; trial design for BCG-naïve NMIBC, BCG-unresponsive carcinoma in situ, and BCG-unresponsive papillary carcinoma; strengths and limitations of single-arm trial designs; assessing patient-reported outcomes; and considerations for assessing avoidance of cystectomy as an efficacy measure. CONCLUSIONS: The workshop discussed several important opportunities for trial design refinement in NMIBC. FDA encourages sponsors to meet with the appropriate review division to discuss trial design proposals for NMIBC early in drug development.

Well-being and Perceptions of Supportive Resources among Caregivers of Patients with Bladder Cancer.

BACKGROUND: The unique burden of treatment and survivorship of patients with bladder cancer can negatively impact caregiver experience and their use of supportive care resources. OBJECTIVE: To assess caregivers' well-being and their perception of potential supportive resources. METHODS: In this cross-sectional survey, caregivers of patients with bladder cancer (N = 630) were recruited through the nationwide Bladder Cancer Advocacy Network Patient Survey Network. We used stakeholder-developed questionnaires to examine caregiver well-being (i.e., physical well-being, tiredness, fear, worry, sadness), the perceived helpfulness of potential resources (i.e., web-based and print-based information, specialized support, personal stories of other caregivers, phone-call and online chat with other caregivers), and influencing factors. RESULTS: Caregivers more frequently reported emotional well-being as a moderate to serious problem (67% for fear, 78% for worry, 66% for sadness) compared with physical well-being (30%) and tiredness (47%). Decreased well-being was associated with female gender of the caregiver, higher than high school education, or caring for a patient with advanced (versus non-invasive) bladder cancer. Of six potential resources, "web-based information" was perceived as "very helpful" among 79% of respondents, followed by "personal stories from other caregivers" (62%). Caregiver preferences for "web-based information" was not associated with any specific demographic or clinical factors. CONCLUSIONS: Caregivers reported moderate to serious problems with emotional and physical well-being. Web-based platforms were perceived as beneficial supportive resources for bladder cancer caregivers. Future intervention research should target the influencing factors identified in this study to optimize the health outcomes of caregivers and enhance the supportive care resources for improving their well-being.

Road to Home Program: A Performance Improvement Initiative to Increase Family and Nurse Satisfaction With the Discharge Education Process for Newly Diagnosed Pediatric Oncology Patients [Formula: see text].

Families of children, adolescents, and young adults with a new oncology diagnosis must absorb knowledge and skills needed to care for their child at home during a period of emergent hospitalizations and intense medical interventions. Effective nurse-led teaching and discharge planning begun at diagnosis can prepare families to safely care for their child following discharge, and be a source of satisfaction. The objective of this performance improvement initiative was to increase family and nurse satisfaction with new diagnosis education and discharge. Using standard performance improvement techniques, family and nursing stakeholder satisfaction with current processes was assessed. Working from established best practice and literature review; The Road to Home was designed and implemented. This novel, comprehensive program includes a visual, interactive display of required education based on the Children's Oncology Group Family Handbook© and hospital specific discharge materials; standardized teaching, tools and documentation for nursing; and caregiver discharge tool kits. Stakeholder input guided improvement strategies throughout the phases of implementation. Sustained increases in family and nurse satisfaction resulted from each phase. The Road to Home program is established for all families of newly diagnosed oncology patients and is meeting goals of increased family and nurse satisfaction with discharge education.

Processing Information After a Child's Cancer Diagnosis-How Parents Learn.

Parents of a child newly diagnosed with cancer must receive an extensive amount of information before their child's initial hospital discharge; however, little is known about best practices for providing this education. An interpretive descriptive study design was used to describe actual and preferred educational content, timing, and methods among parents of children newly diagnosed with cancer prior to their child's first hospital discharge. Twenty parents of children diagnosed with various malignancies participated in individual interviews 2 to 12 months after their child's diagnosis. Data were analyzed using constant comparative analysis. Education delivery occurred in a telling manner at diagnosis transitioning to a reciprocal process of teaching during the inpatient stay, then primarily back to telling immediately before discharge. Parents expressed a variety of preferred learning styles but noted that their preferences were rarely assessed by health care providers. Multiple factors influenced parents' ability to process educational information received during their child's initial hospitalization. Findings suggest that nursing practices should include assessing for influencing factors, providing anticipatory guidance, and incorporating parents' preferred learning style into the educational plan.