Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study.

BACKGROUND: Participants considering early-phase cancer clinical trials (CTs) need to understand the unique risks and benefits prior to providing informed consent. This qualitative study explored the factors that influence patients' decisions about participating in early-phase cancer immunotherapy CTs through the ethical lens of relational autonomy. METHODS: Using an interpretive descriptive design, interviews were conducted with 21 adult patients with advanced cancer who had enrolled in an early-phase CT. Data was analyzed using relational autonomy ethical theory and constant comparative analysis. RESULTS: The extent to which participants perceived themselves as having a choice to participate in early-phase cancer immunotherapy CTs was a central construct. Perceptions of choice varied according to whether participants characterized their experience as an act of desperation or as an opportunity to receive a novel treatment. Intersecting psychosocial and structural factors influenced participants' decision making about participating in early-phase cancer immunotherapy trials. These relational factors included: (1) being provided with hope; (2) having trust; (3) having the ability to withdraw; and (4) timing constraints. CONCLUSIONS: Findings highlight the continuum of perceived choice that exists among patients with cancer when considering participation in early-phase cancer immunotherapy CTs. All participants were interpreted as exhibiting some degree of relational autonomy within the psychosocial and structural context of early-phase CT decision making. This study offers insights into the intersection of cancer care delivery, personal beliefs and values, and established CT processes and structures that can inform future practices and policies associated with early-phase cancer immunotherapy CTs to better support patients in making informed decisions.

Access to cancer clinical trials for racialised older adults: an equity-focused rapid scoping review protocol.

BACKGROUND: The intersection of race and older age compounds existing health disparities experienced by historically marginalised communities. Therefore, racialised older adults with cancer are more disadvantaged in their access to cancer clinical trials compared with age-matched counterparts. To determine what has already been published in this area, the rapid scoping review question are: what are the barriers, facilitators and potential solutions for enhancing access to cancer clinical trials among racialised older adults? METHODS: We will use a rapid scoping review methodology in which we follow the six-step framework of Arksey and O'Malley, including a systematic search of the literature with abstract and full-text screening to be conducted by two independent reviewers, data abstraction by one reviewer and verification by a second reviewer using an Excel data abstraction sheet. Articles focusing on persons aged 18 and over who identify as a racialised person with cancer, that describe therapies/therapeutic interventions/prevention/outcomes related to barriers, facilitators and solutions to enhancing access to and equity in cancer clinical trials will be eligible for inclusion in this rapid scoping review. ETHICS AND DISSEMINATION: All data will be extracted from published literature. Hence, ethical approval and patient informed consent are not required. The findings of the scoping review will be submitted for publication in a peer-reviewed journal and presentation at international conferences.

Mitigating inequity: ethically prioritizing patients for CAR T-cell therapy.

Manufacturing capacity and institutional infrastructure to deliver chimeric antigen receptor T-cell therapies (CAR-T) are pressured to keep pace with the growing number of approved products and expanding eligible patient population for this potentially life-saving therapy. Consequently, many cell therapy programs must make difficult decisions about which patient should get the next available treatment slot. This situation requires an ethical framework to ensure fair and equitable decision-making. In this perspective, we discuss the application of Accountability for Reasonableness (A4R), a priority-setting framework grounded in procedural justice, to the problem of limited CAR-T slots at our institution. We formed a multidisciplinary working group spanning several hematological malignancies. Through multiple rounds of partner engagement, we used A4R guiding principles to identify 4 main criteria to prioritize patients for CAR-T: medical benefit, safety/risk of complications, psychosocial factors, and medical urgency. Associated measures/tools and an implementation process were developed. We discuss further how ethical principles of fairness and equity demand a consistent approach within health systems that does not disadvantage medically underserved or underrepresented populations and supports overcoming barriers to care. In our commitment to transparency and collaboration, we make our tools available to others, ideally to be used to engage in their own A4R process, adapting the tools to their unique environments. Our hope is that our preliminary work will support the advancement of further study in this area globally, aiming for justice in resource allocation for all potential CAR-T candidates, wherever they may seek care.

Complication Rates and Utilization Trends of 3-Level Posterior Column Osteotomy Compared to Single-Level Pedicle Subtraction Osteotomy.

OBJECTIVE: The objective of this study is to assess differences in complication profiles between 3-level posterior column osteotomy (PCO) and single-level pedicle subtraction osteotomy (PSO) as both are reported to provide similar degrees of sagittal correction. METHODS: The PearlDiver database was queried retrospectively using International Classification of Disease, 9th and 10th edition and Current Procedural Terminology codes to identify patients who underwent PCO or PSO for degenerative spine disease. Patients under age 18 or with history of spinal malignancy, infection, or trauma were excluded. Patients were separated into 2 cohorts, 3-level PCO or single-level PSO, matched at a 1:1 ratio based on age, sex, Elixhauser comorbidity index, and number of fused posterior segments. Thirtyday systemic and procedure-related complications were compared. RESULTS: Matching resulted in 631 patients for each cohort. PCO patients had decreased odds of respiratory (odds ratio [OR], 0.58; 95% confidence interval [CI], 0.43-0.82; p = 0.001) and renal complications (OR, 0.59; 95% CI, 0.40-0.88; p = 0.009) compared to PSO patients. There was no significant difference in cardiac complications, sepsis, pressure ulcer, dural tear, delirium, neurologic injuries, postoperative hematoma, postoperative anemia, or overall complications. CONCLUSION: Patients who undergo 3-level PCO have decreased respiratory and renal complications compared to single-level PSO. No differences were found in the other complications studied. Considering both procedures achieve similar sagittal correction, surgeons should be aware that 3-level PCO offers an improved safety profile compared to single-level PSO.

Neuroma Treatment With the Acellular Nerve Allograft Reconstruction Technique.

Treatment of a painful neuroma is a challenging problem for both the patient and the providers. Current surgical treatment options typically include excision of the neuroma and stump relation. However, with both treatment options, patients have high rates of persistent pain and rates of neuroma recurrence. We describe two patients with neuromas treated with our acellular nerve allograft reconstruction technique. This technique involves the excision of the neuroma and bridging the proximal nerve end to the surrounding tissue with an acellular nerve allograft. Both patients had immediate resolution of their neuropathic pain that was maintained at their final follow-up. Acellular nerve allograft reconstruction is a promising treatment option for the treatment of painful neuromas.

Neuro-oncology clinicians' perspectives on factors affecting brain cancer patients' access to medical assistance in dying: A qualitative study.

In most jurisdictions where medical assistance in dying (MAiD) is legal, patients must have decision-making capacity. Brain cancer often damages the cognitive networks required to maintain decision-making capacity. Using qualitative methodology guided by a relational ethics conceptual framework, this study explored neuro-oncology clinicians' perspectives on access to and eligibility for MAiD for patients diagnosed with brain cancer. We interviewed 24 neuro-oncology clinicians from 6 countries. Participants described the unique challenges facing brain cancer patients, potentially resulting in their inequitable access to MAiD. The findings highlight the importance of early end-of-life conversations, advance care planning, and access to end-of-life treatment options.

Influence of donor age and comorbidities on transduced human adipose-derived stem cell in vitro osteogenic potential.

Human adipose-derived mesenchymal stem cells (ASCs) transduced with a lentiviral vector system to express bone morphogenetic protein 2 (LV-BMP-2) have been shown to reliably heal bone defects in animal models. However, the influence of donor characteristics such as age, sex, race, and medical co-morbidities on ASC yield, growth and bone regenerative capacity, while critical to the successful clinical translation of stem cell-based therapies, are not well understood. Human ASCs isolated from the infrapatellar fat pads in 122 ASC donors were evaluated for cell growth characteristics; 44 underwent additional analyses to evaluate in vitro osteogenic potential, with and without LV-BMP-2 transduction. We found that while female donors demonstrated significantly higher cell yield and ASC growth rates, age, race, and the presence of co-morbid conditions were not associated with differences in proliferation. Donor demographics or the presence of comorbidities were not associated with differences in in vitro osteogenic potential or stem cell differentiation, except that transduced ASCs from healthy donors produced more BMP-2 at day 2. Overall, donor age, sex, race, and the presence of co-morbid conditions had a limited influence on cell yield, proliferation, self-renewal capacity, and osteogenic potential for non-transduced and transduced (LV-BMP-2) ASCs. These results suggest that ASCs are a promising resource for both autologous and allogeneic cell-based gene therapy applications.

Effects of cell seeding technique and cell density on BMP-2 production in transduced human mesenchymal stem cells.

Small animal models have demonstrated the efficacy of ex vivo regional gene therapy using scaffolds loaded with BMP-2-expressing mesenchymal stem cells (MSCs). Prior to clinical translation, optimization of seeding techniques of the transduced cells will be important to minimize time and resource expenditure, while maximizing cell delivery and BMP-2 production. No prior studies have investigated cell-seeding techniques in the setting of transduced cells for gene therapy applications. Using BMP-2-expressing transduced adipose-derived MSCs and a porous ceramic scaffold, this study compared previously described static and dynamic seeding techniques with respect to cell seeding efficiency, uniformity of cell distribution, and in vitro BMP-2 production. Static and negative pressure seeding techniques demonstrated the highest seeding efficiency, while orbital shaking was associated with the greatest increases in BMP-2 production per cell. Low density cell suspensions were associated with the highest seeding efficiency and uniformity of cell distribution, and the greatest increases in BMP-2 production from 2 to 7 days after seeding. Our results highlight the potential for development of an optimized cell density and seeding technique that could greatly reduce the number of MSCs needed to produce therapeutic BMP-2 levels in clinical situations. Further studies are needed to investigate in vivo effects of cell seeding techniques on bone healing.

Improving Lentiviral Transduction of Human Adipose-Derived Mesenchymal Stem Cells.

Lentiviral transduction of human mesenchymal stem cells (MSCs) induces long-term transgene expression and holds great promise for multiple gene therapy applications. Polybrene is the most commonly used reagent to improve viral gene transfer efficiency in laboratory research; however, it is not approved for human use and has also been shown to impair MSC proliferation and differentiation. Therefore, there is a need for optimized transduction protocols that can also be adapted to clinical settings. LentiBOOST (LB) and protamine sulfate are alternative transduction enhancers (TEs) that can be manufactured to current Good Manufacturing Practice standards, are easily applied to existing protocols, and have been previously studied for the transduction of human CD34+ hematopoietic stem cells. In this study, we investigated these reagents for the enhancement of lentiviral transduction of adipose-derived MSCs. We found that the combination of LB and protamine sulfate could yield comparable or even superior transduction efficiency to polybrene, with no dose-dependent adverse effects on cell viability or stem cell characteristics. This combination of TEs represents a valuable clinically compatible alternative to polybrene with the potential to significantly improve the efficiency of lentiviral transduction of MSCs for gene therapy applications.

Nonarthroplasty Management of Shoulder Arthritis in the Aging Athlete: Biologics and Arthroscopy.

Glenohumeral arthritis in athletes or young and active individuals constitutes a challenging clinical problem, and multiple factors should be taken into consideration when deciding on nonsurgical or surgical treatment in this patient cohort. Selection of therapy should be based on clinical evidence, but the therapeutic strategy should align with patient expectations. Patient education on the nature and progression of shoulder osteoarthritis may facilitate the decision-making process regarding the selection of treatment. The orthopaedic surgeon should be knowledgeable about the nonarthroplasty options for the management of shoulder osteoarthritis in the aging athlete, with special focus on nonsurgical treatment options and shoulder arthroscopy.

Open Stabilization Procedures of the Shoulder in the Athlete: Indications, Techniques, and Outcomes.

Shoulder instability is a relatively common injury especially in the young athletic population and its surgical management continues to remain a controversial topic in sports medicine orthopedics. Anterior instability is the most common type encountered and is estimated to have an incidence rate of 0.08 per 1000 person-years in the general population; however, this figure is likely higher in the young athletic population. While in recent practice, arthroscopic surgery has become the new gold standard for management, reported failure rates as high as 26% and high recurrence rates in specific subpopulations such as young men in high collision sports have led to the consideration of alternative open procedures such as open Bankart repair, Latarjet, capsular shift, and glenoid bone grafting. These procedures may be preferred in specific patient subgroups such as young athletes involved in contact sports and those with Hill-Sachs defects and multidirectional instability, with postoperative recurrence rates of instability as low as 10%. The purpose of this review is to provide an overview of different open surgical techniques in the management of shoulder instability and summarize patient outcomes including recurrence rates for shoulder instability, return to sport, range of motion (ROM), muscle strength, and complications either individually by procedure or in comparison with other techniques, with special focus on their impact in the athletic population.

Utilizing Google Trends to Track Online Interest in Elective Hand Surgery During the COVID-19 Pandemic.

Introduction Elective hand surgery encompasses a large volume of orthopaedic cases annually. Carpal tunnel syndrome, ganglion cysts, and trigger digits are some of the most common pathologies treated by hand surgeons. In the midst of the COVID-19 pandemic, patient's interest in elective hand surgery for these conditions is uncertain. The objective of this study is to use Google Trends to track online interest in elective hand surgery in the United States during the COVID-19 pandemic. Methods Online search trends regarding elective orthopaedic hand surgery were obtained via Google Trends from November 2019 to November 2020. Three common hand pathologies in lay terms ("carpal tunnel," "'ganglion cyst' + 'wrist cyst,'" and "trigger finger") and three hand surgery-specific keywords ("hand surgery," "carpal tunnel surgery," and "trigger finger surgery") were used as search terms. The search volume index (SVI) graphs for the United States for both sets of search terms were then generated from the Google Trends data and compared to the seven-day average of new COVID-19 cases per day as reported by the CDC. A separate SVI graph was then created for the search term "coronavirus" and was compared against both sets of search terms as above. Results Search trends for all elective hand pathologies and surgery-specific keywords remained constant from November 2019 to the beginning of March 2020 and then decreased significantly within a one-month period following the peak in COVID-19 cases the week of March 15, 2020. Search trends for these keywords increased to baseline levels over the next few months. The search trend for "coronavirus" demonstrated a small search volume index peak of 13 during January 2020 followed by the maximum peak of 100 during the week of March 15, 2020, corresponding to the decrease in search trends of elective hand surgery at that time. Conclusions Online interest in elective hand surgery remained constant prior to the COVID-19 pandemic; however, there was a marked decrease in search trends of elective hand surgery with the rise in daily reported COVID-19 cases, suggesting that patient's interest in elective hand surgery decreased with the onset of the pandemic.

Managing Perioperative Pain After Anterior Cruciate Ligament (ACL) Reconstruction: Perspectives from a Sports Medicine Surgeon.

Anterior cruciate ligament reconstructions (ACLR) are a relatively common procedure in orthopedic sports medicine with an estimated 130,000 arthroscopic operations performed annually. Most procedures are carried out on an outpatient basis, and though success rates of ACLR are as high as 95%, pain remains the most common postoperative complication delaying patient discharge, and thereby increasing the costs associated with patient care. Despite the success and relative frequency of ACLR surgery, optimal and widely accepted strategies and regimens for controlling perioperative pain are not well established. In recent years, the paradigm of pain control has shifted from exclusively utilizing opiates and opioid medications in the acute postoperative period to employing other agents and techniques including nerve blocks, intra-articular and periarticular injections of local anesthetic agents, NSAIDs, and less commonly, ketamine, tranexamic acid (TXA), sedatives, gabapentin, and corticosteroids. More often, these agents are now used in combination and in synergy with one another as part of a multimodal approach to pain management in ACLR, with the goal of reducing postoperative pain, opioid consumption, and the incidence of delayed hospital discharge. The purpose of this review is to consolidate current literature on various agents involved in the management of postoperative pain following ACLR, including the role of classically used opiate and opioid medications, as well as to describe other drugs currently utilized in practice either individually or in conjunction with other agents as part of a multimodal regimen in pain management in ACLR.

Medical Assistance in Dying in patients with advanced cancer and their caregivers: a mixed methods longitudinal study protocol.

BACKGROUND: The legal criteria for medical assistance in dying (MAiD) for adults with a grievous and irremediable medical condition were established in Canada in 2016. There has been concern that potentially reversible states of depression or demoralization may contribute to the desire for death (DD) and requests for MAiD. However, little is known about the emergence of the DD in patients, its impact on caregivers, and to what extent supportive care interventions affect the DD and requests for MAiD. The present observational study is designed to determine the prevalence, predictors, and experience of the DD, requests for MAiD and MAiD completion in patients with advanced or metastatic cancer and the impact of these outcomes on their primary caregivers. METHODS: A cohort of patients with advanced or metastatic solid tumour cancers and their primary caregivers will be recruited from a large tertiary cancer centre in Toronto, Ontario, Canada, to a longitudinal, mixed methods study. Participants will be assessed at baseline for diagnostic information, sociodemographic characteristics, medical history, quality of life, physical and psychological distress, attitudes about the DD and MAiD, communication with physicians, advance care planning, and use of psychosocial and palliative care interventions. Measures will subsequently be completed every six months and at the time of MAiD requests. Quantitative assessments will be supplemented by qualitative interviews in a subset of participants, selected using quota sampling methods. DISCUSSION: This study has the potential to add importantly to our understanding of the prevalence and determinants of the DD, MAiD requests and completions in patients with advanced or metastatic cancer and of the experience of both patients and caregivers in this circumstance. The findings from this study may also assist healthcare providers in their conversations about MAiD and the DD with patients and caregivers, inform healthcare providers to ensure appropriate access to MAiD, and guide modifications being considered to broaden MAiD legislation and policy.

Neuro-Oncology Clinicians' Attitudes and Perspectives on Medical Assistance in Dying.

BACKGROUND: Medical assistance in dying (MAiD), also known as physician-assisted death, is currently legal in several locations across the globe. Brain cancer or its treatments can lead to cognitive impairment, which can impact decision-making capacity for MAiD. OBJECTIVE: We sought to explore neuro-oncology clinicians' attitudes and perspectives on MAiD, including interpretation of decision-making capacity for patient MAiD eligibility. METHODS: An online survey was distributed to members of national and international neuro-oncology societies. We asked questions about decision-making capacity and MAiD, in part using hypothetical patient scenarios. Multiple choice and free-text responses were captured. RESULTS: There were 125 survey respondents. Impaired cognition was identified as the most important factor that would signal a decline in patient capacity. At least 26% of survey respondents had moral objections to MAiD. Respondents thought that different hypothetical patients had capacity to make a decision about MAiD (range 18%-58%). In other hypothetical scenarios, fewer clinicians were willing to support a MAiD decision for a patient with an oligodendroglioma (26%) vs. glioblastoma (41%-70%, depending on the scenario). Time since diagnosis, performance status, and patient age seemed to affect support for MAiD decisions (Fisher's exact P-values 0.007, < 0.001, and 0.049, respectively). CONCLUSION: While there are differing opinions on the moral permissibility of MAiD in general and for neuro-oncology patients, most clinicians agree that capacity must be assessed carefully before a decision is made. End-of-life discussions should happen early, before the capacity is lost. Our results can inform assessments of patient capacity in jurisdictions where MAiD is legal.

Venous Thromboembolic Prophylaxis After Total Hip and Knee Arthroplasty.

➤: The selection of an agent for prophylaxis against venous thromboembolism (VTE) is a balance between efficacy and safety. The goal is to prevent symptomatic VTE while limiting the risk of bleeding. ➤: The optimal agent for VTE prophylaxis has not been identified. The American College of Chest Physicians guidelines recommend that, after total hip or total knee arthroplasty, patients receive at least 10 to 14 days of 1 of the following prophylaxis agents: aspirin, adjusted-dose vitamin K antagonist, apixaban, dabigatran, fondaparinux, low-molecular-weight heparin, low-dose unfractionated heparin, rivaroxaban, or portable home mechanical compression. ➤: The use of aspirin for VTE prophylaxis has increased in popularity over the past decade because it is effective, and it is an oral agent that does not require monitoring. The true efficacy of aspirin needs to be determined in multicenter randomized clinical trials. ➤: Validated risk stratification protocols are essential to identify the safest and most effective regimen for VTE prophylaxis for individual patients. There is no consensus regarding the optimal method for risk stratification; the selection of a prophylaxis agent should be determined by shared decision-making with the patient to balance the risk of thrombosis versus bleeding. ➤: Patients with atrial fibrillation being treated with chronic warfarin therapy or direct oral anticoagulants should stop the agent 3 to 5 days prior to surgery. Patients do not typically require bridging therapy prior to surgery.

Gatekeeping in cancer clinical trials in Canada: The ethics of recruiting the "ideal" patient.

BACKGROUND: Perspectives of clinical trial (CT) personnel on accrual to oncology CTs are relatively absent from the literature. This study explores CT personnel's experience recruiting patients to oncology CTs. METHODS: A qualitative study design was utilized. In-depth, individual interviews with 12 oncology CT personnel were conducted, including six CT nurses and six physician-investigators. Interviews were digitally recorded and transcribed verbatim. Data were subjected to thematic and ethical analysis to identify key concepts and themes. RESULTS: CT personnel reported considering two ethical commitments in CT recruitment: maintaining trial integrity and ensuring patient autonomy through obtaining informed consent. The process of gatekeeping emerged as a way to navigate these ethical commitments during CT accrual. Gatekeeping was influenced by: (a) perceptions of patients' personal suitability for a trial, and (b) healthcare resources and infrastructure. CT personnel's discernment of personal suitability was influenced by patients' cognitive and mental health status, language and cultural background, geographic location, family support, and disease status. Three structural factors impacted gatekeeping: complexity of CTs, consent process, and time limitations in the healthcare system. CT personnel experienced most factors as constraints to accrual and gaining patients' informed consent. CONCLUSION: CT personnel discussed navigating ethical challenges in CT recruitment by offering enrollment to specific patient populations, exacerbating other ethical tensions. Systems-level strategies are needed to address barriers to ethical CT recruitment. Future research should investigate the role of policies and/or tools (eg, decision aids) to support patients and CT personnel's discussions about CT participation, promote more ethical recruitment, and potentially increase accrual.

First Ready, First to Go: Ethical Priority-Setting of Allogeneic Stem Cell Transplant at a Major Cancer Centre.

Medical advancements have now made it possible to provide allogeneic stem cell transplantation (allo-SCTs) to older patients and use stem cells from less well-matched donors. This has resulted in access to a life-saving modality for a greater number of patients with imminent life-threatening illnesses. However, resources have not always kept pace with innovation and expanded volumes. During the summer of 2015 in the province of Ontario, Canada, inadequate resources contributed to a capacity crisis, resulting in extended wait-lists for allo-SCT across the province. This situation presented unique ethical challenges, including the need for ongoing negotiations with health system partners and nimble process management to ensure timely delivery of care. This article reports on the process one organization used to determine how to equitably allocate scarce allo-SCT resources. With the ever-expanding landscape of new and emerging medical technologies, our experience has implications for the ethics of translating other increasingly expensive health technologies to clinical care.

Evaluation of Adolescents' and Young Adults' Attitudes Toward Participation in Cancer Clinical Trials.

PURPOSE: Participation in cancer clinical trials (CCTs) for adolescents and young adults (AYAs) remains the lowest of any patient group with cancer. Little is known about the personal barriers to AYA accrual. The aim of this study was to explore AYA attitudes that influence CCT participation. METHODS: A mixed-methods approach was used. AYAs and non-AYAs (≥ 40 years) completed the Cancer Treatment subscale of the Attitudes Toward Cancer Trials Scales and 9 supplementary questions formed from interview analysis. Differences between AYA and non-AYA cohorts were analyzed using the Mann-Whitney U test, and logistic regression models were constructed to evaluate the effect of demographics on perceptions of CCTs. RESULTS: Surveys were distributed to 61 AYAs (median age, 29 years; range, 17-39 years) and 74 non-AYAs (median age, 55 years; range, 40-88 years). Compared with non-AYAs, AYAs perceived CCTs to be unsafe/more difficult (Personal Barrier/Safety domain; P = .01). There were no differences based on age in other domains. AYAs were also more concerned with CCT interference in their long-term goals (P = .04). Multivariable ordered logistic regression identified increased personal barriers in the Personal Barrier/Safety domain for AYAs (P = .01), in patients with English as a second language (ESL; P < .01), and in patients previously not offered a clinical trial (P = .03). Long-term goals were identified as a barrier in particular tumor types (P = .01) and in patients with ESL (P < .01), with a trend identified in AYAs (P = .12). CONCLUSION: Age-related differences in attitudes toward CCTs suggest that tailored approaches to CCT accrual are warranted. Patient-centered delivery of information regarding CCTs, particularly in patients with ESL and who are trial naïve, may improve accrual.

Perceptions of and decision making about clinical trials in adolescent and young adults with Cancer: a qualitative analysis.

BACKGROUND: Adolescent and young adults (AYA) enrolment rates into cancer clinical trials (CCT) are the lowest of any age group globally. As AYA have distinct biological, psychosocial and relational needs, we aimed to explore any unique factors influencing their CCT decision-making process, including AYA-specific perceptions or attitudes towards CCT. METHODS: Qualitative interpretive descriptive methodology was used to explore AYA perceptions and decision-making related to CCT. An analytic approach conducive to inductive imagining and exploratory questioning was used in order to generate insights and interpret data. RESULTS: A total of 21 AYA were interviewed (median age: 31 (18-39)). Twelve (57%) participants had previously been approached to participate in CCT. Major themes influencing trial enrolment decisions were: 1) severity of illness/urgency for new treatment 2) side effect profile of investigational drug in the short and long term (e.g., impact on future quality of life) 3) who approached patient for trial participation (oncologist vs. other) 4) additional information found on-line about the trial and investigators, and 5) family, friends and peer group opinion regarding the CCT. CONCLUSIONS: Several psychosocial and relational factors were identified as influencing AYA CCT decisions, some of which are unique to this demographic. Specific strategies to address barriers to CCT and enable supportive decision-making include: 1) involving family in decision-making and 2) helping AYA appreciate short- and long-term implications of trial participation. Finally, exploring social networking and general education about CCT that AYA can independently access may increase participation.