Citations 224

A new method to analyze adverse events longitudinally in oncology clinical trials.

Journal of Clinical Oncology | January 3, 2019 | Volume: 32 | Issue: 15_suppl | Pages: 3622-3622

10.1200/jco.2014.32.15_suppl.3622

Biologic pathways, candidate genes, and molecular markers associated with quality-of-life domains.

Journal of Clinical Oncology | January 3, 2019 | Volume: 32 | Issue: 15_suppl | Pages: 1561-1561

10.1200/jco.2014.32.15_suppl.1561

Quality of life (QOL) among patients (pts) with HER2+ breast cancer (bc) treated with adjuvant lapatinib and/or trastuzumab in the ALTTO study (BIG 2-06, Alliance N063D).

Journal of Clinical Oncology | January 3, 2019 | Volume: 32 | Issue: 15_suppl | Pages: 647-647

10.1200/jco.2014.32.15_suppl.647

Combining survival and toxicity effect sizes from clinical trials into an interpretable, quality-adjusted survival effect size estimate of treatment efficacy.

Journal of Clinical Oncology | January 3, 2019 | Volume: 32 | Issue: 15_suppl | Pages: 6630-6630

10.1200/jco.2014.32.15_suppl.6630

Normative data and clinically significant effect sizes for single-item numerical linear analogue self-assessment (LASA) scales.

Journal of Clinical Oncology | January 3, 2019 | Volume: 32 | Issue: 15_suppl | Pages: e17619-e17619

10.1200/jco.2014.32.15_suppl.e17619

Lessons learned from implementing the first Alliance NCORP Research Base Cancer Care Delivery Research (CCDR) trial A191402CD.

Journal of Clinical Oncology | September 25, 2018 | Volume: 36 | Issue: 30_suppl | Pages: 175-175

10.1200/jco.2018.36.30_suppl.175

175 Background: Biomedical research focused on the experiences of cancer patients in care delivery has progressed remarkably in recent years, including the emergence of Cancer Care Delivery Research (CCDR) within the NCI Community Oncology Research Program (NCORP). CCDR is a relatively new mechanism with the NCORP to support protocols that test questions beyond standard clinical trials for treatment or symptom control interventions. CCDR leverages the NCORP infrastructure to develop and test care delivery interventions in community hospital settings and in settings serving underserved and minority populations. CCDR enables researchers to conduct care delivery studies in critical places and in niche populations. Methods: We will describe our experience coordinating the first Alliance NCORP Research Base Cancer CCDR trial. Our trial – a four arm, cluster-randomized trial of decision aids among sites capable of oversampling minority men with a diagnosis of early stage prostate cancer – was the first CCDR trial in the Alliance NCORP Research Base. We will describe the opportunities and challenges we encountered. Results: We implemented a CCDR protocol even as the oversight for CCDR was being worked out in parallel. Curating partnerships outside of established channels of clinical trials, engaging minority serving institutions, and engaging surgical practices like urology illustrate some of the challenges of implementing a care-delivery trial in a diverse multi-site network. Research staff must learn the art of mitigating the disruption of care delivery research procedures within clinics. Additionally, the researcher’s skills are drawn upon at multiple points— establishing relationships, advocating for flexibility in implementing rules, cheerleading, connecting dots, and directing traffic. Conclusions: Our “lessons learned” presentation will provide an experiential account that will inform aspiring care delivery researchers in their work and describe some of the emerging aspects of the institutional implementation of new initiatives in modern cooperative group research. Our presentation will also inform key stakeholders about how to best facilitate this type of research.
Feasibility of a patient-reported outcomes quality-of-life instrument to improve care in underserved, ethnic minority patients with cancer.

Journal of Clinical Oncology | September 25, 2018 | Volume: 36 | Issue: 30_suppl | Pages: 65-65

10.1200/jco.2018.36.30_suppl.65

65 Background: We need better methods to understand the social determinants of health and integrate psychosocial and economic sequelae of cancer and its treatment into healthcare delivery for ethnoculturally diverse population. A Patient-Reported Outcomes Quality of Life (PROQOL) instrument has been developed to capture less commonly discussed patient concerns (Personal Relationships, Emotional health, Physical health, Cancer diagnosis and treatment, Money and Care planning) and improve patient-provider communication. We sought to adapt this instrument and pilot it in underserved, ethnically diverse solid tumor and hematological malignancies patients at Maricopa Integrated Health System (MIHS) in Phoenix, AZ. Methods: Two focus groups (FG) were conducted to understand patient perspectives of an adapted Spanish version of PROQOL. This version was then piloted among patients on active cancer treatment. Patients also completed a Linear Analog Scale Assessment (from 1-10) for quality of life (QOL) and its domains (higher scores indicate better QOL). Results: All participants in both FG (11/12 female) were Hispanics, with a median age of 53 years. Participants agreed that the domains covered in the PROQOL represented the most important psychosocial needs in their cancer continuum. No difficulty in understanding the individual domains or questions for delving deeper into each domain was noted. Median age of 34 pilot study participants (74% female) was 48 years, 79% were Hispanic, 10% were African Americans and median household income was $ 43,924 (range 23,002-98,382). 28/34 completed the Spanish version. Most common concerns were ‘Money’ (32%): difficulty paying medical bills and non-medical expenses and ‘Cancer Diagnosis, Treatment and Survivorship’ (32%): type of cancer and treatment concerns. Median overall QOL was 8 (range 3-10). Conclusions: PROQOL is feasible for systematic capture of patient concerns in underserved, ethnic minority cancer patients. A better understanding of these challenges can help design interventions to improve psychosocial and financial outcomes for the vulnerable groups and decrease disparities in care delivery.
Beyond maximum grade: A novel method to assess toxicity over time in clinical trials of targeted therapy in lymphoma.

Journal of Clinical Oncology | September 6, 2018 | Volume: 34 | Issue: 15_suppl | Pages: 7546-7546

10.1200/jco.2016.34.15_suppl.7546

Association between patient perception of oncology clinical trial participation and survival: N0392 (Alliance).

Journal of Clinical Oncology | September 6, 2018 | Volume: 34 | Issue: 15_suppl | Pages: e18122-e18122

10.1200/jco.2016.34.15_suppl.e18122

Patient preference for receiving information about long-term symptoms.

Journal of Clinical Oncology | September 6, 2018 | Volume: 35 | Issue: 15_suppl | Pages: e21681-e21681

10.1200/jco.2017.35.15_suppl.e21681

e21681 Background: Maintaining quality of life with minimal symptoms is an important goal of cancer treatment. We surveyed patients undergoing cancer treatment about their preferences for information about the long-term symptom burden associated with their current treatment. Methods: Patients undergoing active cancer treatment were enrolled at two large cancer centers from 1/2014 to 7/2015. At the time of enrollment patients reported their household income, employment, performance status and their agreement with the statement, “It would be useful to know the percentage of patients having persistent symptoms more than a year after getting the same treatment I am getting.” Treatment intention (curative vs. palliative) was reported by the treating oncologist. Results: 196 patients completed the survey. The mean age was 55.7 (range 20-80); 54% were female, 69% were white, and 60% were receiving palliative treatment. The majority (83%) of patients either strongly agreed or somewhat agreed that it would be helpful to have information about future symptoms. In univariable analyses, this preference did not significantly differ based on patient-reported performance status, sex, age, treatment intent, race, or household income. Using a more stringent criterion to dichotomize the outcome, 59% of participants strongly agreed that it would be helpful to have information about future symptoms. Patients undergoing treatment with curative intent were significantly more likely to strongly agree (72% vs. 51%, p = 0.0035). In a multivariable analysis adjusting for age, sex, income level, employment status, and patient-reported performance status, participants undergoing curative versus palliative treatment had 3.1 times the odds (95% CI 1.47-6.65) of strongly agreeing. Conclusions: The majority of patients undergoing cancer treatment wanted to know what symptoms to expect in the future, and this was independent of patient demographics. Patients undergoing treatment with curative intent are significantly more likely to want this information than patients undergoing palliative treatment. Symptom data collected through research studies and registries should be summarized by treatment and other key predictors and made available to patients.