Evaluating the impact of financial toxicity among cancer clinical trial participants

e18756 Background: The COVID-19 pandemic has created unprecedented disruptions to cancer clinical trial research across the world due to a temporary global suspension of patients’ recruitment to cancer clinical trials. Access to clinical trials permits better treatment options and best clinical practice standards for patients with cancer. We present the impact of the COVID-19 pandemic on cancer clinical trial activity at the Cancer Clinical Trials Unit (CCTU) at the Mid-Western Cancer Centre, University Hospital Limerick (UHL). Over the last 4 years 28 clinical trials, both interventional and translational, have opened here, across a variety of primary disease sites, with 5 trials opened in 2017, 11 in 2018, 7 in 2019 but only 2 in the first 10 months of 2020 until 3 further trials were opened in December. Methods: CCTU records were reviewed to identify the number of patients screened and consented to participate in cancer clinical trials at UHL in 2020, which were compared directly with corresponding numbers for 2019. Results: In 2019, 17 clinical trials were open and recruiting at the CCTU, UHL. During 2020, 19 trials were recruiting although during the 1st surge of the COVID-19 pandemic recruitment was essentially suspended and CCTU staff were redeployed throughout the hospital. 1st Six months 2020 vs 2019 In the six months from January 2020 until the end of June 2020, 99 patients were screened and only 15 (15.2%) signed informed consent to participate in a cancer clinical trial. When these figures are directly compared with the first six months of 2019, there is a 33% reduction in patients screened for participation (147 vs 99) and a 60% reduction in patients consented (37 vs 15) to clinical trials. 12 Months 2020 vs 2019 In total during 2019, 376 patients were screened for inclusion to participate and 49 (13%) patients signed informed consent to participate in a clinical trial within CCTU at UHL. In 2020, 914 patients were screened for participation with 51 patients consented to participate (5.6%). The majority (45/51 (88%)) of patients consented to cancer clinical trials in 2020 at the CCTU, UHL were recruited to translational based studies and only 6 (12%) consented to interventional studies compared with 2019 when 30/49 (61%) consented to translational and 30/49 (39%) to interventional studies. Conclusions: During the COVID-19 pandemic, the percentage of patients consented to participation in a clinical trial reduced significantly, as compared to the previous year (5.6% vs 13%). Fewer interventional studies have recruited patients during 2020. As we enter the third surge of COVID-19 infections in Ireland, we must continue to monitor and identify effective strategies to navigate the ever-changing situation for cancer clinical trials, in an attempt to maintain access to high quality cancer clinical trial opportunities for our patients.

Download Full-text

Mixed-methods research to assess care coordination experiences among NCORP clinical trial participants.

Journal of Clinical Oncology ◽

10.1200/jco.2020.39.28_suppl.168 ◽

2021 ◽

Vol 39 (28_suppl) ◽

pp. 168-168

Author(s):

Izumi Okado ◽

Ian Pagano ◽

Anamalia Su'esu'e ◽

Kevin Cassel ◽

Jessica Rhee ◽

...

Keyword(s):

Clinical Trial ◽

Mixed Methods ◽

Focus Group ◽

Care Coordination ◽

Cancer Care ◽

Additional Benefit ◽

Cancer Clinical Trial ◽

Focus Group Discussions ◽

Group Discussions ◽

Trial Participants

168 Background: According to the Institute of Medicine, care coordination (CC) is a critical component of high-quality cancer care; however, many patients with cancer continue to experience fragmented care. CC experiences among cancer clinical trial (CT) participants are relatively unknown. Using mixed methods, we examined perceptions of CC among patients enrolled on therapeutic CTs conducted through the Hawaii Minority/Underserved NCI Community Oncology Research Program (NCORP). Methods: Forty-five CT participants completed the validated Care Coordination Instrument (CCI). The CCI assesses cancer patients’ perceptions of CC overall and across Communication, Navigation, and Operational domains. Data from 45 non-CT participants matched by age, gender, cancer type (breast, GI, other), and clinical stage from our prior studies served as a control group. Paired t-tests were used to compare the CCI scores between the two groups. Three semi-structured focus group interviews were conducted with 14 CT participants in 2020 and 2021. Results: The mean age of CT participants was 61.7 ( SD = 9.4), with the majority being female (67%) and Asian (56%). The most common cancer disease sites were breast (27%) and GI (16%). CT participants reported significantly higher total CC scores than non-participants ( p =.0008). Similar trends were found for Navigation ( p =.007) and Operational ( p =.001) domain scores. 56% of CT participants reported receiving moderate to high-intensity CC assistance from their clinical research professionals (CRPs). Content analysis of focus group discussions revealed that the majority of CT participants’ comments aligned with CC domains; 42% Communication, 30% Navigation, and 28% Operational. Nearly half of focus group discussions centered on CRPs (47%), including CC support provided by CRPs (26%). Other key themes that emerged from the focus groups included general CT experiences (22%) and CRP involvement as an additional benefit to CT participation (15%). Conclusions: Clinical trial participants perceive better CC than non-CT participants, partly attributed to CC support provided by CRPs. Our findings highlight a generally unrecognized yet integral role of CRPs as part of a cancer clinical trial care team. CRP involvement may be an additional benefit of CT participation and contribute to improved quality and value for patient-centered cancer care.

Download Full-text

Financial toxicity, symptom burden, illness perceptions, and communication confidence in cancer clinical trial participants.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.6526 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 6526-6526

Author(s):

Subha Perni ◽

Emily Gorton ◽

Elyse R Park ◽

Bruce Allan Chabner ◽

Beverly Moy ◽

...

Keyword(s):

Clinical Trial ◽

Adverse Effects ◽

Illness Perceptions ◽

Symptom Burden ◽

Cancer Clinical Trial ◽

Cancer Type ◽

Financial Toxicity ◽

Significant Difference ◽

Patient Reported ◽

Trial Cost

6526 Background: Cancer clinical trial (CCT) participants are at high risk for experiencing adverse effects from financial toxicity, yet this remains understudied in the CCT population. We sought to describe associations among patient-reported financial toxicity (financial burden [FB] and trial cost concerns), physical and psychological symptoms, illness perceptions, and communication confidence in CCT participants. Methods: From 7/2015-7/2017, we prospectively enrolled CCT participants who expressed interest in financial assistance and a group of patients matched by age, sex, cancer type, specific trial, and trial phase. We assessed FB (burdened by costs of cancer care), trial cost concerns (worried about affording medical costs of a CCT), physical (Edmonton Symptom Assessment Scale [ESAS]) and psychological (Patient Health Questionnaire-4 [PHQ-4]) symptoms, illness perceptions (Brief Illness Perception Questionnaire [BIPQ]), and communication confidence (Perceived Efficacy in Patient-Physician Interactions [PEPPI]). We used regression models to explore sociodemographic associations with FB and trial cost concerns, and to examine associations of FB and trial cost concerns with patients’ symptom burden, illness perceptions, and communication confidence, adjusting for age, sex, race, performance status, marital status, and metastatic status. Results: Of 198 patients enrolled, 112 (56.6%) reported FB and 82 (41.4%) had trial cost concerns. Patients with FB were younger (OR 0.96, 95% CI 0.94-0.98) and had lower incomes ( < $100,000, OR 4.61, 95% CI 2.35-9.01). Patients reporting trial cost concerns also had lower incomes ( < $100,000, OR 2.78, 95% CI 1.45-5.29). On adjusted analyses, patients with FB had higher ESAS total (OR 1.03, 95% CI 1.02-1.05), ESAS physical (OR 1.04, 95% CI 1.02-1.07), PHQ-4 depression (OR 1.54, 95% CI 1.22-1.94), and PHQ-4 anxiety (OR 1.30, 95% CI 1.08-1.55) scores, as well as more negative illness perceptions (OR 1.04, 95% CI 1.01-1.07), but no significant difference in communication confidence (OR 0.98, 95% CI 0.93-1.05). Patients reporting trial cost concerns had higher ESAS total (OR 1.03, 95% CI 1.01-1.05), ESAS physical (OR 1.04, 95% CI 1.01-1.06), PHQ-4 depression (OR 1.35, 95% CI 1.10-1.65), and PHQ-4 anxiety (OR 1.27, 95% CI 1.07-1.51) scores, as well as more negative illness perceptions (OR 1.06, 95% CI 1.03-1.10), and lower communication confidence (OR 0.93, 95% CI 0.87-0.99). Conclusions: In this study of CCT participants, younger patients with lower incomes were most vulnerable to financial toxicity. Financial toxicity was associated with greater symptom burden, more negative illness perceptions, and lower communication confidence, which underscores the importance of addressing these issues when seeking to alleviate the adverse effects of financial toxicity in CCT participants.

Download Full-text

Factors Associated With Age Disparities Among Cancer Clinical Trial Participants

JAMA Oncology ◽

10.1001/jamaoncol.2019.2055 ◽

2019 ◽

Vol 5 (12) ◽

pp. 1769 ◽

Cited By ~ 32

Author(s):

Ethan B. Ludmir ◽

Walker Mainwaring ◽

Timothy A. Lin ◽

Austin B. Miller ◽

Amit Jethanandani ◽

...

Keyword(s):

Clinical Trial ◽

Cancer Clinical Trial ◽

Factors Associated ◽

Age Disparities ◽

Trial Participants

Download Full-text

Prevalence of potentially inappropriate prescribing in a subpopulation of older European clinical trial participants: a cross-sectional study

BMJ Open ◽

10.1136/bmjopen-2017-019003 ◽

2018 ◽

Vol 8 (3) ◽

pp. e019003 ◽

Cited By ~ 10

Author(s):

David O Riordan ◽

Carole Elodie Aubert ◽

Kieran A Walsh ◽

Anette Van Dorland ◽

Nicolas Rodondi ◽

...

Keyword(s):

Clinical Trial ◽

Screening Tool ◽

Inappropriate Prescribing ◽

Community Dwelling ◽

System Level ◽

Potentially Inappropriate Prescribing ◽

Duration Of Action ◽

Significant Difference ◽

The Impact ◽

Trial Participants

ObjectivesTo estimate and compare the prevalence and type of potentially inappropriate prescribing (PIP) and potential prescribing omissions (PPOs) among community-dwelling older adults (≥65 years) enrolled to a clinical trial in three European countries.DesignA secondary analysis of the Thyroid Hormone Replacement for Subclinical Hypothyroidism Trial dataset.ParticipantsA subset of 48/80 PIP and 22/34 PPOs indicators from the Screening Tool of Older Persons Prescriptions/Screening Tool to Alert doctors to Right Treatment (STOPP/START) V2 criteria were applied to prescribed medication data for 532/737 trial participants in Ireland, Switzerland and the Netherlands.ResultsThe overall prevalence of PIP was lower in the Irish participants (8.7%) compared with the Swiss (16.7%) and Dutch (12.5%) participants (P=0.15) and was not statistically significant. The overall prevalence of PPOs was approximately one-quarter in the Swiss (25.3%) and Dutch (24%) participants and lower in the Irish (14%) participants (P=0.04) and the difference was statistically significant. The hypnotic Z-drugs were the most frequent PIP in Irish participants, (3.5%, n=4), while it was non-steroidal anti-inflammatory drug and oral anticoagulant combination, sulfonylureas with a long duration of action, and benzodiazepines (all 4.3%, n=7) in Swiss, and benzodiazepines (7.1%, n=18) in Dutch participants. The most frequent PPOs in Irish participants were vitamin D and calcium in osteoporosis (3.5%, n=4). In the Swiss and Dutch participants, they were bone antiresorptive/anabolic therapy in osteoporosis (9.9%, n=16, 8.6%, n=22) respectively. The odds of any PIP after adjusting for age, sex, multimorbidity and polypharmacy were (adjusted OR (aOR)) 3.04 (95% CI 1.33 to 6.95, P<0.01) for Swiss participants and aOR 1.74 (95% CI 0.79 to 3.85, P=0.17) for Dutch participants compared with Irish participants. The odds of any PPOs were aOR 2.48 (95% CI 1.27 to 4.85, P<0.01) for Swiss participants and aOR 2.10 (95% CI 1.11 to 3.96, P=0.02) for Dutch participants compared with Irish participants.ConclusionsThis study has estimated and compared the prevalence and type of PIP and PPOs among this cohort of community-dwelling older people. It demonstrated a significant difference in the prevalence of PPOs between the three populations. Further research is urgently needed into the impact of system level factors as this has important implications for patient safety, healthcare provision and economic costs.

Download Full-text