PREF-NET: a patient preference and experience study of lanreotide autogel administered in the home versus hospital setting among patients with gastroenteropancreatic neuroendocrine tumours in the UK.

PURPOSE: PREF-NET reported patients' experience of Somatuline® (lanreotide) Autogel® (LAN) administration at home and in hospital among patients with gastroenteropancreatic neuroendocrine tumours (GEP-NETs). METHODS: PREF-NET was a multicentre, cross-sectional study of UK adults (aged ≥ 18 years) with GEP-NETs receiving a stable dose of LAN, which comprised of (1) a quantitative online survey, and (2) qualitative semi-structured interviews conducted with a subgroup of survey respondents. The primary objective was the description of overall patient preference for home versus hospital administration of LAN. Secondary objectives included describing patient-reported opinions on the experience and associated preference for each administration setting, and the impact on healthcare utilisation, societal cost, activities of daily living and health-related quality of life (HRQoL). RESULTS: In the primary analysis (80 patients; mean age 63.9 years), 98.7% (95% confidence interval [CI]: 96.1-100.0) of patients preferred to receive LAN at home, compared with 1.3% (95% CI: 0.0-3.9) who preferred the hospital setting. Among participants, over half (60.3%) received their injection from a non-healthcare professional. Most patients (79.5% [95% CI: 70.5-88.4]) reported a positive effect on HRQoL after the switch from hospital to home administration. Qualitative interviews (20 patients; mean age 63.6 years) highlighted that patients preferred home administration because it improved overall convenience; saved time and costs; made them feel more comfortable and relaxed, and less stressed; and increased confidence in their ability to self-manage their treatment. CONCLUSION: Almost all patients preferred to receive LAN treatment at home rather than in hospital with increased convenience and psychological benefits reported as key reasons for this preference.

Observations with alpelisib in older patients (≥ 65 year of age) with breast cancer in a non-clinical trial setting.

PURPOSE: Alpelisib is newly-available breast cancer agent that targets PIK3 mutations and confers a somewhat unusual adverse event profile. This study focused on older patients (≥ 65 years of age) treated outside a clinical trial to gain further experience on how these under-studied patients do with this new agent. METHODS: This descriptive, multi-site study relied on medical record review. RESULTS: Fifty-one older breast cancer patients were started on alpelisib between May 2019 and September 2020. The median age and number of comorbidities at alpelisib initiation was 71 years and 4, respectively. Thirty-five patients had stopped alpelisib (median time on drug 2.6 months (range: < 1, 9.5 months)) for the following reasons: alpelisib adverse events (n = 15), cancer progression (n = 13), and other/unknown (n = 7). Alpelisib adverse events included hyperglycemia (n = 37), diarrhea (n = 23), rash (n = 19), fatigue (n = 12), and mouth sores (n = 7); (numbers in parentheses indicate the number of patients with at least one such event). Five patients were hospitalized for hyperglycemia. At the time of report, 14 patients were deceased, and median survival had not been reached. CONCLUSION: Older patients might derive further benefit from alpelisib if the adverse event profile of this agent, particularly the hyperglycemia, were able to be better managed.

Spatial and Temporal Epidemiology of Infectious Syphilis in Victoria, Australia, 2015-2018.

ABSTRACT: This analysis of notified syphilis cases in Victoria, Australia between 2015 and 2018 shows that the syphilis epidemic in Victoria has become more generalized, with increases among heterosexual men and women residing in outer Melbourne suburbs-areas that differ from those of gay men.

Nanoliposomal irinotecan (Nal-IRI)-based chemotherapy after irinotecan -based chemotherapy in patients with pancreas cancer.

BACKGROUND: Nanoliposomal irinotecan (Nal-IRI) is a preferred second-line treatment for metastatic pancreas cancer. It is unclear, however, whether patients who had received irinotecan derive benefit. METHODS: Medical records of metastatic pancreas cancer patients who had received irinotecan and then Nal-IRI were reviewed. The primary endpoint was overall survival after the initiation of Nal-IRI (an a priori threshold of >4 months defined success); adverse events and quotes from the medical record on decision-making were also recorded. RESULTS: Sixty four patients met eligibility criteria with a median age of 65 years (range: 36, 80 years). The median overall survival from initiation of Nal-IRI was 5.1 months (95% confidence interval (CI): 4.3, 5.6 months). An exploratory comparison, based on no cancer progression with irinotecan versus progression, showed improved survival with Nal-IRI in the former group: 6.1 months (95% CI: 5.1, 9.3 months) versus 4.3 months (95% CI: 2.3, 4.8 months); p = 0.0006. Nal-IRI adverse events occurred as expected. Qualitative data illustrate several themes, including "limited treatment options," which appeared to drive the decision to prescribe Nal-IRI. CONCLUSION: Nal-IRI might be considered in pancreas cancer patients who had received irinotecan, particularly in the absence of disease progression with the latter.

Vulval lichen sclerosus: An Australasian management consensus.

BACKGROUND/OBJECTIVES: Vulval lichen sclerosus (VLS) is a chronic inflammatory skin condition predominantly affecting the anogenital region in women and children. To date, there is lack of agreement amongst experts on a severity scale to aid assessment, research and treatment stratification on VLS. Furthermore, literature on best practice for long-term management of VLS is lacking. The aim of this consensus is to provide broad guidelines on the short and long-term management of VLS. METHODS: An initial focus group of Australasian experts in vulval dermatology developed a draft consensus statement for the management of VLS. Based on the results of the draft statement, a consensus panel of 22 Australasian experts, comprised of the initial and additional members, participated in an anonymous four-stage eDelphi process. Round 1 involved generation and voting on statements from the draft consensus statement developed by the focus group. In Rounds 2, 3 & 4, panel members were presented formal feedback from previous rounds and asked to indicate their level of agreement. Consensus was reached if there was ≥70% agreement on the importance of an item in the 4 (agree) to 5 (strongly agree) range. RESULTS: The expert panel, with a total of 504 collective years of experience in the field of VLS, reached consensus on a core set of 51 management statements related to diagnosis, severity, initial and long-term management, follow-up, and complications of VLS. CONCLUSIONS: This study has identified a set of management statements for VLS that may be useful in clinical practice in the Australasian population.

Understanding Verbosity: Funding Source and the Length of Consent Forms for Cancer Clinical Trials.

Consent forms are an important educational tool that helps cancer patients decide on whether or not to enroll on a clinical trial, but wordiness potentially detracts from their educational value. This single-institution study examined word counts of consent forms for all phase I, II, and III solid tumor clinical trials between 2004 and 2010. Consent forms were categorized by trial funding source: (1) pharmaceutical company; (2) National Clinical Trials Network (NCTN); (3) R01- or other non-government grants; and (4) mixed (funding from multiple sources). Three hundred fifteen consent forms were studied; these included 106 (34%) pharmaceutical company; 145 (46%) NCTN; 44 (14%) R01 type; and 20 (6%) mixed. The overall median word count was 5129 words per consent form (interquartile range (IQR) range, 4226 to 6695). The median word counts per consent form (IQR) were 5648 (4814, 6803), 5243 (4139, 6932), 4365 (3806, 5124), and 4319 (3862, 5944), respectively, based on the above funding sources, showing that pharmaceutical company trial consent forms had the highest median word count. Of note, phase of trial was associated with consent form length (phase III were wordier), and consent forms manifested a consistent increase in wordiness over time. These observations underscore a timely need to find ways to limit the verbosity of consent forms, particularly in those from pharmaceutical company trials.

Reconciliation of the carbon budget in the ocean's twilight zone.

Photosynthesis in the surface ocean produces approximately 100 gigatonnes of organic carbon per year, of which 5 to 15 per cent is exported to the deep ocean. The rate at which the sinking carbon is converted into carbon dioxide by heterotrophic organisms at depth is important in controlling oceanic carbon storage. It remains uncertain, however, to what extent surface ocean carbon supply meets the demand of water-column biota; the discrepancy between known carbon sources and sinks is as much as two orders of magnitude. Here we present field measurements, respiration rate estimates and a steady-state model that allow us to balance carbon sources and sinks to within observational uncertainties at the Porcupine Abyssal Plain site in the eastern North Atlantic Ocean. We find that prokaryotes are responsible for 70 to 92 per cent of the estimated remineralization in the twilight zone (depths of 50 to 1,000 metres) despite the fact that much of the organic carbon is exported in the form of large, fast-sinking particles accessible to larger zooplankton. We suggest that this occurs because zooplankton fragment and ingest half of the fast-sinking particles, of which more than 30 per cent may be released as suspended and slowly sinking matter, stimulating the deep-ocean microbial loop. The synergy between microbes and zooplankton in the twilight zone is important to our understanding of the processes controlling the oceanic carbon sink.

IL-35 promotes pancreas cancer growth through enhancement of proliferation and inhibition of apoptosis: evidence for a role as an autocrine growth factor.

Interleukin-35 (IL-35), an IL-12 cytokine family member, mediates the immune inhibitory function of regulatory T cells (Treg). We assayed the presence of IL-35 in paraffin-embedded human pancreas cancer (PCAN) and unexpectedly found IL-35 was expressed mainly by epithelial derived PCAN cells, but not by Treg. We further examined the expression and effect of exogenous IL-35 in human PCAN cell lines and found IL-35 promoted growth and inhibited apoptosis in PCAN cell lines. IL-35 induced proliferation correlated with an increase in cyclin B, cyclin D, cdk2, and cdk4 and a decrease in p27 expression, while inhibition of apoptosis was associated with an increase in Bcl-2 and a decrease in TRAILR1. We conclude IL-35 is produced by PCAN in vivo and promotes PCAN cell line growth in vitro. These results might indicate an important new role for IL-35 as an autocrine growth factor in PCAN growth.

The influence of the toxin-producing dinoflagellate, Alexandrium catenella, on feeding, reproduction and toxin retention in Calanus helgolandicus.

Copepods of the genus Calanus dominate the biomass of pelagic ecosystems from the Mediterranean Sea up into the Arctic Ocean and form an important link between phytoplankton and higher trophic levels. Impacts from toxin-producing harmful algae (HA) have been recorded throughout this region over the last 50 years, with potentially negative effects on Calanus spp. populations and the ecosystem functions and services they provide. Here we examine how ingestion, egg-production and egg-viability in Calanus helgolandicus are affected by the relative abundance of the toxin-producing dinoflagellate Alexandrium catenella in their diet. Our four-day experiments demonstrate that the ingestion rate of C. helgolandicus declined significantly as the percentage of toxin-producing A. catenella within their diet increased, whereas egg production and egg viability were unaffected. Toxin profile concentrations for A. catenella are presented alongside body toxin-loads in C. helgolandicus after 4 days of feeding on these cells. The body toxin concentrations of C. helgolandicus were 3.6-356.6 pg STX diHCl eq. copepod-1, approximately 0.02-3.3 % of the toxins ingested. Our work suggests that the effects of exposure to A. catenella may be negligible in the short-term but could manifest if bloom conditions persist for longer than our experimental duration.

Complete genome sequence of Microbacterium foliorum phage Curie, a podovirus isolated from soil in Spokane, Washington.

Bacteriophage Curie is a podovirus that infects Microbacterium foliorum. The Curie genome spans 16,810 bp, has 90 bp terminal inverted repeats, and includes 23 protein-coding genes. Its genome architecture resembles phage PineapplePizza and other phi29-like phages. Together, Curie and PineapplePizza form a new actinobacteriophage Cluster GI.

Efficacy and Safety of Pharmacokinetically-Driven Dosing of Mycophenolate Mofetil for the Treatment of Pediatric Proliferative Lupus Nephritis-A Double-Blind Placebo Controlled Clinical Trial (The Pediatric Lupus Nephritis Mycophenolate Mofetil Study).

Background: The safety and efficacy of mycophenolate mofetil (MMF) for lupus nephritis (LN) treatment is established in adults and in some children. MMF is rapidly converted to the biologically active metabolite mycophenolic acid (MPA) whose pharmacokinetics (PK) is characterized by large inter- and intra-individual variability. Methods/Design: This randomized, double-blind, active comparator, controlled clinical trial of pediatric subjects with proliferative LN compares pharmacokinetically-guided precision-dosing of MMF (MMFPK, i.e. the dose is adjusted to the target area under the concentration-time curve (AUC0-12h) of MPA ≥ 60-70 mg*h/L) and MMF dosed per body surface area (MMFBSA, i.e. MMF dosed 600 mg/m2 body surface area), with MMF dosage taken about 12 hours apart. At baseline, subjects are randomized 1:1 to receive blinded treatment with MMFPK or MMFBSA for up to 53 weeks. The primary outcome is partial clinical remission of LN (partial renal response, PRR) at week 26, and the major secondary outcome is complete renal response (CRR) at week 26. Subjects in the MMFBSA arm with PRR at week 26 will receive MMFPK from week 26 onwards, while subjects with CRR will continue MMFBSA or MMFPK treatment until week 53. Subjects who achieve PRR at week 26 are discontinued from study intervention. Discussion: The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) study will provide a thorough evaluation of the PK of MMF in pediatric LN patients, yielding a head-to-head comparison of MMFBSA and MMFPK for both safety and efficacy. This study has the potential to change current treatment recommendations for pediatric LN, thereby significantly impacting childhood-onset SLE (cSLE) disease prognosis and current clinical practice.

A potential role for resveratrol as a radiation sensitizer for melanoma treatment.

BACKGROUND: Radiotherapy (XRT) is used to improve local control of melanoma and for palliation of metastatic disease. Clinical use of XRT for melanoma is often limited by extent of disease and the relative radioresistance of melanoma may limit the effectiveness of XRT. Our group and others have previously shown that resveratrol (RSV) enhances radiation sensitivity in radioresistant prostate cancer cell lines. MATERIAL AND METHODS: In this study, the effects of XRT in combination with RSV on radioresistant melanoma lines, SK-Mel-5 and HTB-65, were evaluated by assessment of proliferation and apoptosis. Clonogenic assay, comparison of proliferating cell nuclear antigen staining, Quick Cell Proliferation assay, terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL) staining and caspase-3 activity assay were used to assess proliferation and apoptosis, as appropriate. RESULTS: We found that the percentage of colonies, proliferating cell nuclear antigen + cells and the optical density value of melanoma cells were decreased after addition of RSV to XRT (XRT/RSV). TUNEL + cells and the relative caspase-3 activity in melanoma cells were increased after addition of RSV to XRT (XRT/RSV). We investigated the possible molecular mechanisms of decreased proliferation and increased apoptosis by using reverse transcriptase-polymerase chain reaction and immunohistochemical staining. The anti-proliferative effect of XRT/RSV correlated with decreased expression of pro-proliferative molecule cyclin B, cyclin D, cdk2 and cdk4. The pro-apoptotic effect of XRT/RSV correlated with decreased expression of the anti-apoptotic molecule FLIP, Bcl-2, and survivin. CONCLUSION: These data suggest that RSV enhances radiation sensitivity of melanoma cells by inhibiting proliferation and promoting apoptosis. Resveratrol may have a potential role as a radiation sensitizer for melanoma treatment.

The acute effect of a caffeine-containing energy drink on mood state, readiness to invest effort, and resistance exercise to failure.

The efficacy of caffeine ingestion in enhancing aerobic performance is well established. The evidence for caffeine's effects on resistance exercise is mixed and has not fully examined the associated psychological and psychophysiological changes. This study examined acute effects of ingesting a caffeine-containing energy drink on repetitions to failure, the rating of perceived exertion (RPE), and the readiness to invest physical effort (RTIPE) and mental effort during resistance exercise to failure. Thirteen resistance-trained men took part in this double-blind, randomized cross-over experimental study whereby they ingested a caffeinated (179 mg) energy drink or placebo solution 60 minutes before completing a bout of resistance exercise comprising bench press, deadlift, prone row, and back squat exercise to failure at an intensity of 60% 1-repetition maximum. Experimental conditions were separated by at least 48 hours. Participants completed significantly greater repetitions to failure, irrespective of exercise, in the energy drink condition (p = 0.015). Rating of perceived exertion was significantly higher in the placebo condition (p = 0.02) and was significantly higher during lower-body exercises compared with upper-body exercises irrespective of the substance ingested (p = 0.0001). Readiness to invest mental effort was greater with the energy drink condition (p = 0.04), irrespective of time. A significant time × substance interaction (p = 0.036) for RTIPE indicated that RTIPE increased for both placebo and energy drink conditions preingestion to pre-exercise, but the magnitude of increase was greater with the energy drink condition compared with placebo. This resulted in higher RTIPE postexercise for the energy drink condition. These results suggest that acute ingestion of a caffeine-containing energy drink can enhance resistance exercise performance to failure and positively enhance psychophysiological factors related to exertion in trained men.

Barriers and Facilitators to Physical Activity and FMS in Children Living in Deprived Areas in the UK: Qualitative Study.

Using the socio-ecological model, this qualitative study aimed to explore teachers' perspectives on the barriers and facilitators to Fundamental Movement Skills (FMS) and physical activity engagement in children living in deprived areas in the UK. A purposive sample of 14 primary school teachers participated in semi-structured focus groups drawn from schools situated in lower SES wards and ethnically diverse areas in Central England. Thematic analysis of transcripts identified multiple and interrelated factors across all levels of the socio-ecological model for barriers to FMS and PA (i.e., intrapersonal, interpersonal, organisational, community and policy). Facilitators at three levels of influence were found (i.e., intrapersonal, interpersonal and organisational). We conclude, barriers and enablers to the PA and FMS in children from ethnically diverse backgrounds living in deprived areas are multifactorial and interrelated. At a school level, initiatives to increase PA and develop the FMS needed to be active are likely to be ineffective unless the barriers are addressed at all levels and considered more holistically with their complexity. Multi-disciplinary solutions are needed across sectors given the range of complex and interrelated factors.

Can a key boreal Calanus copepod species now complete its life-cycle in the Arctic? Evidence and implications for Arctic food-webs.

The changing Arctic environment is affecting zooplankton that support its abundant wildlife. We examined how these changes are influencing a key zooplankton species, Calanus finmarchicus, principally found in the North Atlantic but expatriated to the Arctic. Close to the ice-edge in the Fram Strait, we identified areas that, since the 1980s, are increasingly favourable to C. finmarchicus. Field-sampling revealed part of the population there to be capable of amassing enough reserves to overwinter. Early developmental stages were also present in early summer, suggesting successful local recruitment. This extension to suitable C. finmarchicus habitat is most likely facilitated by the long-term retreat of the ice-edge, allowing phytoplankton to bloom earlier and for longer and through higher temperatures increasing copepod developmental rates. The increased capacity for this species to complete its life-cycle and prosper in the Fram Strait can change community structure, with large consequences to regional food-webs.

Alpelisib-induced hyperglycemia in older patients with breast Cancer: Qualitative findings.

BACKGROUND: The PIK3 kinase inhibitor, alpelisib, is a new breast cancer drug that can cause hyperglycemia, which can be especially severe in older patients. Yet, to our knowledge, no prior studies have sought to understand what older patients experience with alpelisib-induced hyperglycemia. METHODS: The medical records of patients who were 65 years of age or older at the initiation of alpelisib and who developed hyperglycemia were reviewed in detail; direct verbiage on hyperglycemia were extracted and reviewed with rigorous qualitative methods. RESULTS: Thirty-four women with a median age of 72 (range: 65, 85) are the subject of this report; twelve had been started on insulin, four had been hospitalized for hyperglycemia, and eleven appeared to stop alpelisib because of hyperglycemia. Qualitative analyses revealed two themes. The first was patient burden, which emanated from patients' having to self-monitor glucose levels ("Monitors blood glucose (BG) 4 times daily"); taking extra medications ("Taking Jardiance 10 mg daily and Pioglitazone 15 mg daily"); frequent changes in insulin dosing ("Her insulin… was then increased…."); and frequent changes in dosing of alpelisib to help control the hyperglycemia ("Instructed to hold Piqray …."), and which also emanated from greater engagement with the healthcare system ("She was hospitalized for hyperglycemia"). The second theme focused on symptomatology and how patients suffered from hyperglycemia ("She presents to the emergency department with pre-syncope and vertigo"). CONCLUSION: Oncologists should assess older patients for the requisite abilities and resources for managing alpelisib-induced hyperglycemia in the event it occurs.

Can older patients adopt and maintain a ketogenic diet? An observational study in support of clinical trials in older patients.

ABSTRACT: Ketogenic diets appear promising for obesity, diabetes, cancer, and other illnesses. Because older patients are more likely to contend with such illnesses and because of a paucity of dietary outcomes among these patients, we examined ketogenic diets in older patients.This multisite study focused on patients (≥65 years of age) on a ketogenic diet. Medical records were identified with the keywords "keto," "ketogenic," and "Atkins." Records were reviewed in detail with extraction of direct quotations to substantiate observations.We report on 200 consecutive patients with a median age of 70 years. Reasons for diet included weight loss, diabetes, and cancer; the majority remained on the diet for >1 month. In 134 (67%: 95% confidence interval: 60, 73%), the ketogenic diet appeared beneficial: 93 of 117 (79%) who sought weight loss lost weight ("She has lost 15 pounds and plans to lose another 8"); 36 of 67 (54%) who sought glucose control appeared to achieve the latter ("He has gone on a ketogenic diet and has been able to bring his sugars down significantly"); and 5 of 8 (63%) who sought improved cancer outcomes appeared to derive them ("He attributes part of the control of his cancer and increased QOL to adopting the keto for cancer diet"). Adverse events occurred in 30 patients (15%): dyslipidemia (n = 14), constipation (n = 9), sub-therapeutic international normalized ratio (n = 3), pancreatitis (n = 2), diarrhea (n = 1), and fatigue (n = 1).Trials that test ketogenic diets for a variety of illnesses should enroll older adults.

Metastatic or suspected metastatic cancer in patients 90 years of age or older: A single-institution, multi-site study.

BACKGROUND: Metastatic cancer in nonagenarians and those older is rare and understudied. Here we explored whether these patients appear to benefit from antineoplastic therapy and whether outcomes differ based on whether or not untreated patients had a histologic/cytologic confirmation of cancer. METHODS: In this single-institution, multi-site study, we reviewed 10 years of consecutive medical records of patients 90+ years of age with a histologic/cytologic cancer diagnosis and metastatic cancer or, alternatively, a presumed metastatic cancer diagnosis. RESULTS: Sixty-eight patients are the focus with a median age of 93 years (range: 90, 103 years). Patients fell into 3 groups: 1) no tissue/cytologic cancer diagnosis and no treatment (=23); 2) tissue/cytologic diagnosis but no treatment (n = 21); and 3) cancer treatment rendered (n = 24). The median survival in groups 1,2, and 3 was 5 weeks (95% confidence interval (CI): 2, 11 weeks), 9 weeks (95% CI: 3, 23 weeks), and 60 weeks (95% CI: 38 weeks, not yet reached), respectively. For those patients in group 3 who received cancer therapy, chemotherapy, radiation, and surgery were administered in 11 (16%), 6 (9%), and 4 (6%), respectively. Fourteen received other cancer therapy: hormonal therapy (n = 6), targeted therapy (n = 6), and immunotherapy (n = 2). Only one patient experienced an adverse event that required hospitalization. CONCLUSIONS: Although these older patients likely received cancer treatment on a selective basis, such treatment was associated with improved survival and was well-tolerated. However, based on survival outcomes, one might question whether to put patients through a biopsy, if they have limited therapeutic options.

How Did a Multi-Institutional Trial Show Feasibility of Electronic Data Capture in Older Patients With Cancer? Results From a Multi-Institutional Qualitative Study (Alliance A171902).

PURPOSE: New technology might pose problems for older patients with cancer. This study sought to understand how a trial in older patients with cancer (Alliance A171603) was successful in capturing electronic patient-reported data. METHODS: Study personnel were invited via e-mail to participate in semistructured phone interviews, which were audio-recorded and qualitatively analyzed. RESULTS: Twenty-four study personnel from the 10 sites were interviewed; three themes emerged. The first was that successful patient-reported electronic data capture shifted work toward patients and toward study personnel at the beginning of the study. One interviewee explained, "I mean it kind of lost all advantages…by being extremely laborious." Study personnel described how they ensured electronic devices were charged, wireless internet access was up and running, and login codes were available. The second theme was related to the first and dealt with data filtering. Study personnel described high involvement in data gathering; for example, one interviewee described, "I answered on the iPad, whatever they said. They didn't even want to use it at all." A third theme dealt with advantages of electronic data entry, such as prompt data availability at study completion. Surprisingly, some remarks described how electronic devices brought people together, "Some of the patients, you know, it just gave them a chance to kinda talk about, you know, what was going on." CONCLUSION: High rates of capture of patient-reported electronic data were viewed favorably but occurred in exchange for increased effort from patients and study personnel and in exchange for data that were not always patient-reported in the strictest sense.

Randomized, Double-Blind Trial on the Impact of Word Count in Cancer Clinical Trial Consent Forms.

PURPOSE: This randomized, double-blind study sought to understand whether cancer clinical trial consent form verbosity detracts from patients' decision making on trial enrollment. METHODS: This trial tested mock consent forms of 2,000, 4,000, and 6,000 words. The first two comprised the two experimental arms and the third the control arm. Phase II was conducted to identify the promising arm, which, in phase III, was compared with the control arm. Each consent form described the same trial. Eligible adult patients reported a cancer history and English literacy. The primary end point used a patient-reported Likert scale to assess the relationship between information in the consent form and trial decision making. RESULTS: In phase II, 93 patients were accrued and prompted the selection of the 2,000-word consent form for phase III. In phase III, 182 patients were recruited, resulting in 240 total evaluable patients to compare the 2,000-word versus the 6,000-word arm (control). For the primary end point, 103 (84%) and 107 (91%) patients in the 2,000- and 6,000-word arms, respectively, strongly agreed or agreed with the following: "The information in this consent form helped me make a decision about whether or not to enroll in the trial" (two-sided, P = .14). Median time to read each consent form was 8 and 12 minutes, respectively (two-sided, P < .0001). Among those assigned these consent forms, 84% and 73%, respectively (two-sided, P = .04) signed or expressed a willingness to sign. CONCLUSION: This study's primary end point was not met. However, secondary outcomes suggest a need to further study the efficiency and efficacy of shorter consent forms for cancer clinical trial enrollment.