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

86 Background: Cancer clinical trial (CCT) participants are at risk for experiencing adverse effects from financial toxicity, yet these remain understudied. We sought to describe associations among CCT participant-reported financial toxicity (financial burden [FB] and trial cost concerns), symptoms, illness perceptions, communication confidence, hospitalizations, and survival. Methods: From 7/2015-7/2017, we prospectively enrolled CCT participants who expressed interest in financial assistance (n = 100) and a patient group matched by age, sex, cancer type, specific trial, and trial phase (n = 98). 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, as well as their associations with symptom burden, illness perceptions, and communication confidence, adjusting for age, sex, race, performance status, marital status, and metastatic status. We also used Kaplan-Meier and regression methods to evaluate their associations with 6-month hospitalizations and survival. 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) with lower incomes (< $100,000, OR 4.61, 95% CI 2.35-9.01). Patients with trial cost concerns had lower incomes (< $100,000, OR 2.78, 95% CI 1.45-5.29). On adjusted analyses, patients with FB had higher ESAS (OR 1.03, 95% CI 1.02-1.05), 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 (OR 1.03, 95% CI 1.01-1.05), 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). Financial toxicity was not significantly associated with hospitalizations or survival. Conclusions: In this study of CCT participants, younger patients with lower incomes were most vulnerable to financial toxicity. Financial toxicity was associated with greater symptoms, more negative illness perceptions, and lower communication confidence, underscoring the importance of addressing these issues when seeking to alleviate the adverse effects of financial toxicity in CCT participants.

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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.

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Illness perceptions, financial toxicity, symptom burden, and survival in cancer clinical trial (CCT) participants.

Journal of Clinical Oncology ◽

10.1200/jco.2020.39.28_suppl.160 ◽

2021 ◽

Vol 39 (28_suppl) ◽

pp. 160-160

Author(s):

Subha Perni ◽

Chukwuma Azoba ◽

Emily Gorton ◽

Elyse R. Park ◽

Bruce Allan Chabner ◽

...

Keyword(s):

Overall Survival ◽

Illness Perceptions ◽

Symptom Burden ◽

Financial Assistance ◽

Cancer Type ◽

Financial Toxicity ◽

Clinical Factors ◽

Patient Centered ◽

Risk Of Death ◽

Trial Phase

160 Background: Patients’ perceptions of their illness are important for treatment decision-making and quality of life. Limited data exist describing associations of illness perceptions with other patient-centered outcomes, particularly in CCT participants. We sought to examine associations among illness perceptions and CCT patients’ financial toxicity, physical and psychological symptoms, and survival. Methods: From 7/2015-7/2017, we prospectively enrolled CCT participants who expressed interest in financial assistance programs (n = 157) and a group of patients matched by age, sex, cancer type, specific trial, and trial phase (n = 103). We assessed baseline illness perceptions (Brief Illness Perceptions Questionnaire [BIPQ] with scores > 50 indicating negative perceptions), financial toxicity (degree costs of cancer care have been a burden, moderate to catastrophic indicating financial toxicity), physical (Edmonton Symptom Assessment Scale [ESAS]) and psychological (Patient Health Questionnaire-4 [PHQ-4]) symptoms. We used descriptive statistics to examine associations of BIPQ and sociodemographic/clinical factors, financial toxicity, ESAS, PHQ-4, and overall survival. We used the Kaplan-Meier method to estimate median survival times and Cox regression to assess the association of BIPQ and overall survival. Results: Among 260 patients, 189 (72.7%) completed BIPQ surveys (median age 69 [Range 26 to 83] years, 66.1% female). 68.8% had negative illness perceptions. We found no significant associations among negative illness perceptions and patients’ age, sex, race, education, marital status, performance status, insurance, cancer type, metastatic disease status, self-reported income, trial phase, trial year, or Charlson Comorbidity Index score. Patients with negative illness perceptions were more likely to report financial toxicity (69.8% vs 48.8%, p = 0.006), and had higher ESAS-total (Medians: 44 [Range 0-89] vs 21 [Range 0-78], p < 0.001), PHQ-4 depression (Medians: 2 [Range 0-6] vs 0 [Range 0-6], p < 0.001), and PHQ-4 anxiety (Medians: 3 [Range 0-6] vs 1 [Range 0-6], p < 0.001) scores. Patients with negative illness perceptions had shorter overall survival (Medians: 22 [Range 10-29] vs 42 [Range 28-Not Reached] months, log-rank p = 0.004). Adjusting for receipt of financial assistance, patients with negative illness perceptions experienced higher risk of death (HR 1.65, 95% CI 1.10-2.48). Conclusions: In this prospective study of CCT participants, we found that patients with negative illness perceptions experienced greater financial toxicity, more symptom burden, and worse survival than those with more positive perceptions, despite comparable sociodemographic/clinical factors. These findings highlight the need to assess and address patients’ illness perceptions and financial burden when seeking to enhance patient-centered outcomes in oncology.

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Intravenous paracetamol versus ketorolac for pain attenuation in patients with renal colic; a randomized, single blind and controlled clinical trial

Journal of Renal Injury Prevention ◽

10.34172/jrip.2020.10 ◽

2020 ◽

Vol 9 (2) ◽

pp. e10-e10

Author(s):

Arash Ardestani Zadeh ◽

Davood Arab ◽

Mohammadreza Moonesan ◽

Majid Mirmohammadkhani ◽

Pouya Morid

Keyword(s):

Clinical Trial ◽

Adverse Effects ◽

Renal Colic ◽

Vital Signs ◽

Analgesic Efficacy ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Intravenous Paracetamol ◽

Significant Difference ◽

Single Blind

Introduction: Pain control is an essential care for patients with renal colic in emergency wards. Objectives: This study aimed to compare the analgesic efficacy of intravenous (IV) paracetamol (PC) versus ketorolac (KET) for patients with renal colic. Patients and Methods: In a randomized controlled clinical trial, 110 patients with renal colic referred to the emergency department of Kosar hospital, Semnan between October 2015 and June 2016 were selected. Eighty-eight patients were divided into two groups (44 patients in each group) of PC (1 g/IV) and KET (30 mg/IV). One patient in each group was excluded during the study. Vital signs and pain severity (measured by visual analogue scale [VAS]) of all patients were recorded at admission time 0, 20, 40 and 60 minutes after treatment. Then, the results were compared in two groups. Results: The results showed that at the time of 0, 20, 40 and 60 minutes after the administration of the PC and KET drugs, no significant difference was seen in severity of pain based on VAS score between the two groups (P<0.05). Moreover, there were no significant differences in the vital signs of two groups (P<0.05). No adverse effects were reported in each group. Conclusion: In conclusion, the use of IV-PC and KET in patients with renal colic had similar pain relieving effects without any adverse effects.

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Effect of THAM upon outcome in severe head injury: a randomized prospective clinical trial

Journal of Neurosurgery ◽

10.3171/jns.1993.78.1.0054 ◽

1993 ◽

Vol 78 (1) ◽

pp. 54-59 ◽

Cited By ~ 94

Author(s):

Aizik L. Wolf ◽

Lion Levi ◽

Anthony Marmarou ◽

John D. Ward ◽

Paul J. Muizelaar ◽

...

Keyword(s):

Clinical Trial ◽

Head Injury ◽

Adverse Effects ◽

Glasgow Coma Scale ◽

Severe Head Injury ◽

Prospective Clinical Trial ◽

Content Type ◽

Coma Scale ◽

Significant Difference ◽

Fine Print

✓ Although mortality and morbidity rates from head injury have been reduced substantially by improved prehospital interventions, intensive care, and aggressive management of intracranial pressure (ICP), successful treatment of the primary brain injury has been elusive. In experimental models, tromethamine (THAM) has been effective in treating head injury; this drug acts by entering the cerebrospinal fluid compartment, reducing cerebral acidosis and ICP, and reversing the adverse effects of prophylactic hyperventilation on early recovery. In this randomized prospective clinical trial, THAM was studied to determine if it had beneficial effects in the early management of severe head injuries and if the adverse effects of hyperventilation could be prevented. A total of 149 patients with severe head injury (Glasgow Coma Scale scores of ≤ 8) were randomly assigned to either a control or a THAM group. Both groups of patients matched in terms of clinical parameters, including age, sex, number of surgical mass lesions, number in each Glasgow Coma Scale stratum, and first ICP measurement. All patients were treated by a standard management protocol, intubated, mechanically ventilated, and maintained in the pCO2 range of 32 to 35 mm Hg for 5 days. Tromethamine was administered as a 0.3-M solution in an initial loading dose (body weight × blood acidity deficit, average 4.27 cc/kg/hr) given over 2 hours, followed by a constant infusion of 1 ml/kg/hr for 5 days. Outcome was measured at 3, 6, and 12 months postinjury. Although analysis indicated no significant difference in outcome between these two groups at 3 months, 6 months, and 1 year, there was a difference regarding ICP. The time that ICP was above 20 mm Hg in the first 48 hours postinjury was less in patients treated with THAM (p < 0.05). Also, the number of patients requiring barbiturate coma was significantly less in the THAM group (5.48% vs. 18.4%, p < 0.05). The authors conclude that THAM ameliorates the deleterious effect of prolonged hyperventilation, may be beneficial in ICP control, and warrants further study as to the dosage and timing of administration.

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Evaluation of Clonidine Augmentation Therapy for Obsessive-Compulsive Disorder Treatment; a Randomized Clinical Trial

Iranian Journal of Psychiatry and Behavioral Sciences ◽

10.5812/ijpbs.112131 ◽

2021 ◽

Vol In Press (In Press) ◽

Author(s):

Shahla Akouchakian ◽

Mohammad Javad Tarrahi ◽

Elham Mohebati

Keyword(s):

Clinical Trial ◽

Adverse Effects ◽

Randomized Clinical Trial ◽

Obsessive Compulsive Disorder ◽

P Value ◽

Augmentation Therapy ◽

Obsessive Compulsive ◽

Global Improvement ◽

Compulsive Disorder ◽

Significant Difference

Background: Obsessive-compulsive disorder (OCD) is a common neuropsychiatric disorder worldwide. Inadequate response of OCD patients to a usual agent makes this disorder a great challenge, and recent studies have recommended augmentation therapy as a new choice. Objectives: As traces of noradrenergic dysfunction have been noted in OCD pathophysiology, the current study aimed to assess the efficacy of clonidine augmentation therapy for treating OCD. Methods: This was a randomized clinical trial conducted on 57 OCD patients divided into the two groups of 1-mg clonidine augmentation therapy (n = 28) and placebo group (n = 29). The medication was administered for 12 weeks. Patients’ primary treatment, including SSRIs or clomipramine, continued by receiving the same dose used before participation in this study. The Yale-Brown Obsessive-Compulsive scale (Y-BOCS) and Clinical Global Impression-Severity scale (CGI-S) were used to assess the patients at the start of the study and then at four-week intervals. Drug-related adverse effects and global improvement were assessed and compared between the two groups. Results: The initial CGI scores were 3.89 ± 1.57 and 4.10 ± 1.61 at the baseline and 2.29 ± 1.18 and 3.07 ± 1.51 at the end of the study in the intervention and control groups, respectively. Both groups revealed a significant improvement (P-value = 0.001) with no significant difference between them (P-value = 0.22). The primary Y-BOCS score in the clonidine-treated group was 27.61 ± 8.08 versus 28.69 ± 7.44 in the control group at the baseline, which declined to 20.25 ± 6.08 versus 25.45 ± 7.35 at the end of the study, respectively. Both groups revealed a significant improvement (P-value = 0.001), but there was no statistically significant difference between them (P-value = 0.06). Drug-related complications were not statistically different between the two groups (P-value > 0.05); however, the clonidine-treated patients presented more adverse effects than control subjects. Conclusions: Although the use of clonidine posed no remarkable drug-related adverse effects, it was not superior to placebo considering symptom relief.

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Continuation therapy with lithium and amitriptyline in unipolar depressive illness: a randomized, double-blind, controlled trial

Psychological Medicine ◽

10.1017/s0033291700003068 ◽

1984 ◽

Vol 14 (1) ◽

pp. 37-50 ◽

Cited By ~ 90

Author(s):

A. I. M. Glen ◽

A. L. Johnson ◽

M. Shepherd

Keyword(s):

Clinical Trial ◽

Adverse Effects ◽

Detailed Analysis ◽

Controlled Trial ◽

Depressive Illness ◽

Double Blind ◽

Prophylactic Efficacy ◽

Continuation Therapy ◽

Significant Difference ◽

Clinically Significant

SynopsisA detailed analysis of the results of a multi-centre clinical trial shows that, while the relapse rate following recovery from an operationally defined depressive illness was smaller among patients subsequently treated with either amitryptiline or lithium than with a placebo, there was no clinically significant difference between the prophylactic efficacy of the 2 antidepressants. An account is given of the relative adverse effects of the treatments, and the implications of the findings are discussed.

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Integrative Oncology Consultations Delivered via Telehealth in 2020 and In-Person in 2019: Paradigm Shift During the COVID-19 World Pandemic

Integrative Cancer Therapies ◽

10.1177/1534735421999101 ◽

2021 ◽

Vol 20 ◽

pp. 153473542199910 ◽

Cited By ~ 1

Author(s):

Santhosshi Narayanan ◽

Gabriel Lopez ◽

Catherine Powers-James ◽

Bryan M Fellman ◽

Aditi Chunduru ◽

...

Keyword(s):

Symptom Management ◽

Healthy Lifestyle ◽

Symptom Burden ◽

Symptom Assessment ◽

Mobile Technologies ◽

Cancer Type ◽

Integrative Oncology ◽

Cancer Symptoms ◽

Patient Reported ◽

Edmonton Symptom Assessment Scale

Background: The COVID-19 pandemic has catalyzed the use of mobile technologies to deliver health care. This new medical model has benefited integrative oncology (IO) consultations, where cancer patients are counseled about healthy lifestyle, non-pharmacological approaches for symptom management, and addressing questions around natural products and other integrative modalities. Here we report the feasibility of conducting IO physician consultations via telehealth in 2020 and compare patient characteristics to prior in-person consultations conducted in 2019. Methods: An integrated EHR-telemedicine platform was used for IO physician consultations. As in the prior in-person visits, patients completed pre-visit patient-reported outcome (PRO) assessments about common cancer symptoms [modified Edmonton Symptom Assessment Scale, (ESAS)], Measure Yourself Concerns and Wellbeing (MYCaW), and the PROMIS-10 to assess quality of life (QOL). Patient demographics, clinical characteristics, and PROs for new telehealth consultation in 2020 were compared to new in-person consultations in 2019 using t-tests, chi-squared tests, and -Wilcoxon rank-sum test. Results: We provided telehealth IO consultations to 509 new patients from April 21, 2020, to October 21, 2020, versus 842 new patients in-person during the same period in 2019. Most were female (77 % vs 73%); median age (56 vs 58), and the most frequent cancer type was breast (48% vs 39%). More patients were seeking counseling on herbs and supplements (12.9 vs 6.8%) and lifestyle (diet 22.7 vs 16.9% and exercise 5.2 vs 1.8%) in the 2020 cohort than 2019, respectively. The 2020 telehealth cohort had lower symptom management concerns compared to the 2019 in-person cohort (19.5 vs 33.1%). Conclusions: Delivering IO consultations using telehealth is feasible and meets patients’ needs. Compared to patients seen in-person during 2019, patients having telehealth IO consultations in 2020 reported lower symptom burden and more concerns about lifestyle and herbs and supplements. Additional research is warranted to explore the satisfaction and challenges among patients receiving telehealth IO care.

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Long Term Evaluation of the Efficacy And And Safety of Nd:Yag Laser Vitreolysis for Symptomatic Vitreous Floaters

10.21203/rs.3.rs-466147/v1 ◽

2021 ◽

Author(s):

Guilherme Nunes ◽

Gustavo Ludwig ◽

Henrique Gemelli ◽

Pedro D Serracarbassa ◽

Márgara Zanotele

Keyword(s):

Clinical Trial ◽

Adverse Effects ◽

Similar Proportion ◽

Life Questionnaire ◽

Double Blind ◽

Vitreous Floaters ◽

Significant Difference ◽

Late Adverse Effects

Abstract PURPOSE: this study evaluates the long-term safety and efficacy of Nd:YAG vitreolysis for symptomatic vitreous floaters, as it remains a controversial procedure due to the lack of robust evidence in the literature for its maintenance of the results and absence of adverse effects. METHODS: this is an observational extension to the previously presented prospective, randomized, double-blind clinical trial study. Eight of thirteen subjects who underwent vitreolysis with YAG laser returned for a late reevaluation, 18 months after the procedure, to evaluate the efficacy and safety of the procedure.RESULTS: all patients maintained the improvement in symptomatology noted after the procedure, with 25% showing complete improvement, and a similar proportion (37.5%) reporting significant or partial improvement. Objective improvement in opacity was similar to that found at 6 months follow-up. The NEI-VFQ 25 quality of life questionnaire showed no statistically significant difference in responses between the sixth and eighteenth month. No adverse effects were noted on clinical examination or reported by patients.CONCLUSION: vitreolysis efficacy observed at 6 months of follow-up was maintained until the eighteenth month, with all patients reporting improvement from the pre-procedure state. No late adverse effects were noted. A larger randomized clinical trial is needed to confirm the safety of the procedure.

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Evaluating the impact of financial toxicity among cancer clinical trial participants

International Journal of Cancer Care and Delivery ◽

10.53876/001c.30796 ◽

2022 ◽

Author(s):

Hala T. Borno ◽

Sylvia Zhang ◽

Tracy Kuo Lin ◽

Li Zhang ◽

Nynikka R. Palmer ◽

...

Keyword(s):

Clinical Trial ◽

Cancer Clinical Trial ◽

Financial Toxicity ◽

The Impact ◽

Trial Participants

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Readability of Cancer Clinical Trials Websites

Cancer Control ◽

10.1177/1073274819901125 ◽

2020 ◽

Vol 27 (1) ◽

pp. 107327481990112

Author(s):

Grace Clarke Hillyer ◽

Melissa Beauchemin ◽

Philip Garcia ◽

Moshe Kelsen ◽

Frances L. Brogan ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Grade Level ◽

Literacy Skills ◽

Reading Level ◽

Cancer Clinical Trial ◽

Cancer Clinical Trials ◽

Flesch Reading Ease ◽

Significant Difference ◽

Clinical Trial Enrollment

Clinical trials are critically important for the development of new cancer treatments. According to recent estimates, however, clinical trial enrollment is only about 8%. Lack of patient understanding or awareness of clinical trials is one reason for the low rate of participation. The purpose of this observational study was to evaluate the readability of cancer clinical trial websites designed to educate the general public and patients about clinical trials. Nearly 90% of Americans use Google to search for health-related information. We conducted a Google Chrome Incognito search in 2018 using the keywords “cancer clinical trial” and “cancer clinical trials.” Content of the 100 cancer clinical trial websites was analyzed using an online readability panel consisting of Flesch-Kincaid Grade Level, Flesch Reading Ease, Gunning-Fog Index, Coleman-Liau Index, and Simple Measure of Gobbledygook scales. Reading level difficulty was assessed and compared between commercial versus non-commercial URL extensions. Content readability was found to be “difficult” (10.7 grade level). No significant difference in readability, overall, and between commercial and non-commercial URL extensions was found using 4/5 measures of readability; 90.9% of commercial versus 49.4% of non-commercial websites were written at a >10th grade ( P = .013) using Gunning-Fog Index. Written cancer clinical trials content on the Internet is written at a reading level beyond the literacy capabilities of the average American reader. Improving readability to accommodate readers with basic literacy skills will provide an opportunity for greater comprehension that could potentially result in higher rates of clinical trial enrollment.

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