scholarly journals Burden of cancer trial participation: A qualitative sub-study of the INTERIM feasibility RCT

2021 ◽  
pp. 174239532110602
Author(s):  
Chidiebere Nwolise ◽  
Pippa Corrie ◽  
Ray Fitzpatrick ◽  
Avinash Gupta ◽  
Crispin Jenkinson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Advanced Melanoma ◽  
Support Network ◽  
Feasibility Trial ◽  
Normalisation Process Theory ◽  
Trial Participation ◽  
Structured Interviews ◽  
Framework Analysis ◽  
Cancer Trial

Objective A qualitative sub-study was carried out within a larger phase II feasibility trial, to identify and describe the burden experienced by advanced melanoma patients participating in a clinical trial and the factors affecting their capacity to cope with the burden. Methods Semi-structured interviews were conducted with fourteen patients with advanced melanoma recruited from National Health Service hospitals in the United Kingdom. Qualitative analysis was undertaken using a framework analysis approach. Normalisation process theory was applied to the concept of research participation burden in order to interpret and categorise findings. Results Burdens of participation were identified as arising from making sense of the trial and treatment; arranging transport, appointment and prescriptions; enacting management strategies and enduring side effects; reflecting on trial documents and treatment efficacy, and emotional and mental effects of randomisation and treatment side effects. Factors reported as influencing capacity include personal attributes and skills, physical and cognitive abilities and support network. Discussion This is the first study to highlight the substantial burden faced by patients with advanced melanoma in a clinical trial and factors that may lessen or worsen the burden. Consideration of identified burdens during trial design and execution will reduce the burden experienced by research participants.

scholarly journals The psychosocial response to a terrorist attack at Manchester Arena, 2017: a process evaluation

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Daniel Hind ◽  
Kate Allsopp ◽  
Prathiba Chitsabesan ◽  
Paul French
Keyword(s):  
Young People ◽  
Process Evaluation ◽  
Terrorist Attack ◽  
Health Sector ◽  
Routine Data ◽  
Recovery Phase ◽  
Normalisation Process Theory ◽  
Structured Interviews ◽  
Framework Analysis ◽  
Response Phase

Abstract Background A 2017 terrorist attack in Manchester, UK, affected large numbers of adults and young people. During the response phase (first seven weeks), a multi-sector collaborative co-ordinated a decentralised response. In the subsequent recovery phase they implemented a centralised assertive outreach programme, ‘The Resilience Hub’, to screen and refer those affected. We present a process evaluation conducted after 1 year. Methods Case study, involving a logic modelling approach, aggregate routine data, and semi-structured interviews topic guides based on the Inter-Agency Collaboration Framework and May’s Normalisation Process Theory. Leaders from health, education and voluntary sectors (n = 21) and frontline Resilience Hub workers (n = 6) were sampled for maximum variation or theoretically, then consented and interviewed. Framework analysis of transcripts was undertaken by two researchers. Results Devolved government, a collaborative culture, and existing clinical networks meant that, in the response phase, a collaboration was quickly established between health and education. All but one leader evaluated the response positively, although they were not involved in pre-disaster statutory planning. However, despite overwhelming positive feedback there were clear difficulties. (1) Some voluntary sector colleagues felt that it took some time for them to be involved. (2) Other VCSE organisations were accused of inappropriate, harmful use of early intervention. (3) The health sector were accused of overlooking those below the threshold for clinical treatment. (4) There was a perception that there were barriers to information sharing across organisations, which was particularly evident in relation to attempts to outreach to first responders and other professionals who may have been affected by the incident. (5) Hub workers encountered barriers to referring people who live outside of Greater Manchester. After 1 year of the recovery phase, 877 children and young people and 2375 adults had completed screening via the Resilience Hub, 79% of whom lived outside Greater Manchester. Conclusions The psychosocial response to terrorist attacks and other contingencies should be planned and practiced before the event, including reviews of communications, protocols, data sharing procedures and workforce capacity. Further research is needed to understand how the health and voluntary sectors can best collaborate in the wake of future incidents.

Receptiveness and barriers to clinical trial participation for oncology patients from a public safety-net hospital.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 83-83
Author(s):  
Victor Yundeh Chiu ◽  
Jacob S. Berkowitz ◽  
Joshua Rodriguez ◽  
Jade Law ◽  
Kristina Lee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Public Safety ◽  
Safety Net ◽  
Trial Participation ◽  
Religious Leader ◽  
Annual Income ◽  
Oncology Patients ◽  
Wage Loss ◽  
Safety Net Hospital

83 Background: Oncologic clinical trial enrollment is low, particularly in underserved populations. Increasing enrollment of public safety-net hospital patients is important to ensure representation of the general population and reduces cancer outcome disparities. To tailor clinical trial outreach, we sought to characterize attitudes towards trial participation of oncology patients at Olive View—UCLA Medical Center (OVMC), a public safety-net hospital in Los Angeles County. Methods: We developed a 39-question survey (Qualtrics, Provo, UT). It was administered via tablets to a convenience sample of patients in OVMC’s medical oncology clinic and infusion center during 2020—2021. The survey was offered to patients fluent in English or Spanish. Results: Of 165 patients who were offered the survey, 11 declined due to illiteracy in any language, 4 did not finish the survey. Median age was 54 (range: 20-81); 63% were female. The majority (76%) reported an annual income below $25,000; 39% did not complete high school. Self-identified ethnicity was Hispanic/Latino (73%), non-Hispanic White (12%), Asian-Pacific Islander (9%), and Black (4%). Based on a 5-point Likert scale of comfort speaking English, 48% had English proficiency (EP). Overall, 69% of patients expressed interest in trials. When considering participation, patients would seek advice from their physician (86%), family (32%), other medical staff (14%), alternative medicine practitioner (7%), friend (6%), or religious leader (4%). Concerns regarding trial participation were lack of knowledge regarding trials (47%), fear of side effects (43%), frequent visits (25%), cost (20%), transportation (14%), wage loss (9%), and inability to determine own treatment (4%). Patients found the following modalities useful for learning about trials: website (43%), paper handout (39%), video (37%), discussion with prior participants (34%). Patients with annual income > $25,000 were significantly more concerned about cost (33.3% v. 15.8%, p = 0.04) and treatment side effects (61.1% v. 36.8%, p = 0.02). EP patients were more likely to find a website (54.2% vs. 32.1%, p = 0.01) or discussion with prior participants (45.8% v. 23.1%, p < 0.01) helpful compared to low EP patients. Conclusions: There is considerable interest in oncologic clinical trials in this predominantly Hispanic/Latino population. This population had significant trust in physicians for guidance on trial enrollment, and had minimal concern for out-of-pocket cost, wage loss, or transportation issues. The majority of patients did not find additional informational resources helpful. Structural barriers rather than patient-level variables are likely the primary drivers of low oncologic trial enrollment. Future efforts should focus on improving access to appropriate trials and leveraging the physician-patient relationship for increasing trial participation.

scholarly journals Experiences of augmented arm rehabilitation including supported self-management after stroke: a qualitative investigation

2020 ◽  
pp. 026921552095638
Author(s):  
Stefanie Schnabel ◽  
Frederike van Wijck ◽  
Brenda Bain ◽  
Mark Barber ◽  
Philippa Dall ◽  
...  
Keyword(s):  
Feasibility Trial ◽  
Self Management ◽  
Daily Routine ◽  
Stroke Survivors ◽  
Structured Interviews ◽  
Framework Analysis ◽  
Daily Lives ◽  
Daily Routines ◽  
Arm Rehabilitation ◽  
Normalization Process

Objective: To explore the experiences of stroke survivors and their carers of augmented arm rehabilitation including supported self-management in terms of its acceptability, appropriateness and relevance. Design: A qualitative design, nested within a larger, multi-centre randomized controlled feasibility trial that compared augmented arm rehabilitation starting at three or nine weeks after stroke, with usual care. Semi-structured interviews were conducted with participants in both augmented arm rehabilitation groups. Normalization Process Theory was used to inform the topic guide and map the findings. Framework analysis was applied. Setting: Interviews were conducted in stroke survivors’ homes, at Glasgow Caledonian University and in hospital. Participants: 17 stroke survivors and five carers were interviewed after completion of augmented arm rehabilitation. Intervention: Evidence-based augmented arm rehabilitation (27 additional hours over six weeks), including therapist-led sessions and supported self-management. Results: Three main themes were identified: (1) acceptability of the intervention (2) supported self-management and (3) coping with the intervention. All stroke survivors coped well with the intensity of the augmented arm rehabilitation programme. The majority of stroke survivors engaged in supported self-management and implemented activities into their daily routine. However, the findings suggest that some stroke survivors (male >70 years) had difficulties with self-management, needing a higher level of support. Conclusion: Augmented arm rehabilitation commencing within nine weeks post stroke was reported to be well tolerated. The findings suggested that supported self-management seemed acceptable and appropriate to those who saw the relevance of the rehabilitation activities for their daily lives, and embedded them into their daily routines.

scholarly journals Understanding the management of heart failure with preserved ejection fraction: a qualitative multiperspective study

2020 ◽  
Vol 70 (701) ◽  
pp. e880-e889
Author(s):  
Emma Sowden ◽  
Muhammad Hossain ◽  
Carolyn Chew-Graham ◽  
Tom Blakeman ◽  
Stephanie Tierney ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Illness Perceptions ◽  
Systems Of Care ◽  
Normalisation Process Theory ◽  
Preserved Ejection Fraction ◽  
Structured Interviews ◽  
Framework Analysis ◽  
Obesity And Diabetes ◽  
Improved Model

BackgroundAbout half of all people with heart failure have heart failure with preserved ejection fraction (HFpEF), in which the heart is stiff. This type of heart failure is more common in older people with a history of hypertension, obesity, and diabetes mellitus. Patients with HFpEF are often managed in primary care, sometimes in collaboration with specialists. Knowledge about how best to manage this growing population is limited, and there is a pressing need to improve care for these patients.AimTo explore clinicians’ and patients’/carers’ perspectives and experiences about the management of HFpEF to inform the development of an improved model of care.Design and settingA multiperspective qualitative study involving primary and secondary care settings across the east of England, Greater Manchester, and the West Midlands.MethodSemi-structured interviews and focus groups were conducted. Transcribed data were analysed using framework analysis and informed by the normalisation process theory (NPT).ResultsIn total, 50 patients, nine carers/relatives, and 73 clinicians were recruited. Difficulties with diagnosis, unclear illness perceptions, and management disparity were identified as important factors that may influence management of HFpEF. The NPT construct of coherence reflected what participants expressed about the need to improve the identification, understanding, and awareness of this condition in order to improve care.ConclusionThere is a pressing need to raise the public and clinical profile of HFpEF, develop a clear set of accepted practices concerning its management, and ensure that systems of care are accessible and attuned to the needs of patients with this condition.

scholarly journals Under consent: participation of people with HIV in an Ebola vaccine trial in Canada

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Pierre-Marie David ◽  
Benjamin Mathiot ◽  
Oumy Thiongane ◽  
Janice E. Graham
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Vaccine Trial ◽  
Study Participant ◽  
Trial Participation ◽  
Structured Interviews ◽  
Contextual Diversity ◽  
Healthcare Needs ◽  
Study Participants ◽  
Trial Participants

Abstract Background Little is known about volunteers from Northern research settings who participate in vaccine trials of highly infectious diseases with no approved treatments. This article explores the motivations of HIV immunocompromised study participants in Canada who volunteered in a Phase II clinical trial that evaluated the safety and immunogenicity of an Ebola vaccine candidate. Methods Observation at the clinical study site and semi-structured interviews employing situational and discursive analysis were conducted with clinical trial participants and staff over one year. Interviews were recorded, transcribed and analysed using critical qualitative interpretivist thematic analytical techniques. Patterns were identified, clustered and sorted to generate distinct and comprehensive themes. We then reassembled events and contexts from the study participants’ stories to develop two ideal portraits based on "composite characters" based on study participants features. These provide ethnographically rich details of participants’ meaningful social worlds while protecting individual identities. Results Ten of the 14 clinical trial participants, and 3 study staff were interviewed. Participant demographics and socio-economic profiles expressed limited contextual diversity. Half were men who have sex with men, half were former injection drug users experiencing homelessness, one was female, none were racialized minorities and there were no people from HIV endemic countries. Fully 90% had previous involvement in other clinical studies. Their stories point to particular socio-economic situations that motivated their participation as clinical labor through trial participation. Conclusions Our findings support Fisher’s argument of “structural coercion” in clinical trial recruitment of vulnerable individuals experiencing precarious living conditions. Clinical trials should provide more detail of the structural socio-economic conditions and healthcare needs which lie “under consent” of study participants. Going well beyond an overly convenient narrative of altruism, ethical deliberation frameworks need to sufficiently address the structural conditions of clinical trials. We offer concrete possibilities for this and acknowledge that further research and clinical data should be made available underlying study participant contexts with regards to recruitment and participation in resource poor settings, in both the South and the North.

scholarly journals Adolescents’ and Parents’ Attitudes Toward Adolescent Clinical Trial Participation: Changes Over One Year

2018 ◽  
Vol 13 (4) ◽  
pp. 383-390 ◽  
Author(s):  
Rebecca K. Tsevat ◽  
Carmen Radecki Breitkopf ◽  
Sara E. Landers ◽  
Ariel M. de Roche ◽  
Christine Mauro ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Health Study ◽  
Trial Participation ◽  
Willingness To Participate ◽  
Clinical Trial Participation ◽  
Framework Analysis ◽  
New Knowledge ◽  
One Year ◽  
Qualitative Responses ◽  
Over Time

Little is known about how adolescents’ and parents’ thoughts about participation in clinical trials change over time. In this study, adolescent (14-17 years)–parent dyads were asked about willingness to participate in a hypothetical reproductive health study. A year later, they were asked how their thoughts about the study had changed. Qualitative responses were coded and analyzed using framework analysis. Thirty-two percent of adolescents and 18% of parents reported changes in thoughts; reasons included general changes in perception, clearer understanding, new knowledge or experiences, increased maturity/age of adolescents, and changes in participants independent of the study. Adolescents and parents may benefit from learning about studies multiple times, and investigators should account for development and new experiences to optimize adolescent research enrollment.

scholarly journals “This Is Something That Changed My Life”: A Qualitative Study of Patients' Experiences in a Clinical Trial of Ketamine Treatment for Alcohol Use Disorders

2021 ◽  
Vol 12 ◽  
Author(s):  
O. Merve Mollaahmetoglu ◽  
Johanna Keeler ◽  
Katherine J. Ashbullby ◽  
Eirini Ketzitzidou-Argyri ◽  
Meryem Grabski ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Quantitative Research ◽  
Controlled Trial ◽  
Trial Participation ◽  
Therapeutic Effects ◽  
Structured Interviews ◽  
Double Blind ◽  
Therapeutic Benefits ◽  
Psychoactive Effects ◽  
Randomised Controlled

Background: The therapeutic benefits of ketamine have been demonstrated for a variety of psychiatric disorders. However, the role of ketamine induced psychoactive experiences in mediating the therapeutic effects is unclear. Despite the growing quantitative research on the efficacy of ketamine treatment, very few studies examined participant experiences of ketamine infusions in a treatment setting.Aims: The current study aimed to examine participant experiences of ketamine infusions and how these relate to therapeutic mechanisms in a clinical trial setting.Methods: We conducted semi-structured interviews with 12 participants who received up to three ketamine infusions (0.8 mg/kg) as part of a Phase II double blind, randomised controlled trial. The interviews explored participants' acute experiences of ketamine infusions, experiences of psychotherapy/education, and the lasting effects of the trial. The interviews were transcribed verbatim and analysed using thematic analysis.Results: Six key themes were identified. (1) Participants reported multifaceted motivations for trial participation. (2) The set and setting was found to be influential in determining acute ketamine experiences. The acute ketamine experiences included: (3) the inherent contradictions of the experience (e.g., dissociation vs feelings of connection), (4) rapidly fluctuating and changing experiences, (5) meaningful, mystical and spiritual experiences. Finally, the final theme (6) relates to the transformational effects of the infusions and the trial.Conclusion: Provided in a supportive and professional environment, ketamine treatment led to a significant change in relationship with alcohol. Ketamine induced ego dissolution and dissociation were reported to be related to the transformational effects on relationship with alcohol. The extent to which the acute psychoactive effects of ketamine mediate therapeutic effects on drinking outcomes remain to be investigated in the trial data. The acute effects of ketamine reported by our participants transcend its traditional conceptualisation as a “dissociative anaesthetic”; therefore, we suggest the development or use of new measures alongside ketamine infusions to fully capture the spectrum of these effects which may be crucial in its therapeutic and transformative effects.

Types of information that patients with lung cancer with targetable driver mutations and their caregivers learn from online forums: Results of a qualitative study.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 161-161
Author(s):  
Laura A Petrillo ◽  
Ashley Zhou ◽  
Haiwen Gui ◽  
Robert Sommer ◽  
Jessica Jiyeong Lin ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Side Effects ◽  
Qualitative Study ◽  
Information Exchange ◽  
Driver Mutations ◽  
Online Forums ◽  
Structured Interviews ◽  
Framework Analysis ◽  
Cancer Subtypes ◽  
Types Of Information

161 Background: Patients and caregivers seek information about cancer from a variety of sources in addition to their medical team. In recent years, patients with specific lung cancer subtypes have created advocacy groups with active online forums for networking, support, and information exchange. We sought to describe the types of information that patients and caregivers learned from their peers online about lung cancer with targetable driver mutations. Methods: In this qualitative study, we enrolled patients with lung cancer with targetable driver alterations in EGFR, ALK, or ROS1 genes and their caregivers. We conducted individual, semi-structured interviews with participants from a single academic center, asking about their experiences learning about and living with lung cancer. Three reviewers used a framework analysis to code transcripts, and we synthesized the codes into themes. In this analysis, we focused on one theme that emerged from the data related to the information that participants learned from online forums. Results: Of 59 patients approached, 39 patients (mean age = 59, 56% female, median time from diagnosis 16 months) and 16 caregivers (69% male, all spouses or long-term partners) agreed to participate and completed interviews. Participants used online forums to compare their experiences with others to gain a preview of what might lie ahead. Specifically, they read about patients with long survival that were a source of hope, as well as patients’ experiences of progression and dying from cancer that made clinical estimates of prognosis more personal and vivid. Online forums provided a venue to learn about the latest research, available clinical trials, how to manage side effects, and where to find expert clinicians. Participants learned about the treatments received by patients at other centers. They were also exposed to emotionally intense stories of patients from around the world who lacked access to targeted therapy and sought advice from other forum members about how to find specialized care. Caregivers pointed out the distressing effect on patients of learning bad news about online peers as a downside of online forums, but overall found them beneficial and supported patients’ engagement with them. Conclusions: Online forums, particularly those that narrowly focus on specific diseases or treatments, provide patients and caregivers with anecdotal evidence that helps them with practical matters, such as how to manage side effects, as well as more existential issues, such as how long they can expect to live. These results suggest that clinicians should be open to and curious about the information that patients and caregivers learn from online forums in order to better understand the perspectives that patients and caregivers bring to discussions and decisions about their cancer.

A survey of patients with laryngotracheal stenosis on future clinical trial design

2022 ◽  
pp. 174077452110657
Author(s):  
Ioan Lina ◽  
Alexandra Berges ◽  
Rafael Ospino ◽  
Kevin Motz ◽  
Ruth Davis ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Trial Design ◽  
Treatment Options ◽  
Clinical Trial Design ◽  
Trial Participation ◽  
Controlled Clinical Trial ◽  
Laryngotracheal Stenosis ◽  
Oral Ulcers ◽  
Gastrointestinal Side Effects

Background/Aims Laryngotracheal stenosis is a rare but devastating proximal airway fibrosis that restricts a patient’s ability to breathe. Treatment is primarily surgical and to date, there has never been a multi-institutional, randomized, prospective, and interventional clinical trial for a medical therapy to treat laryngotracheal stenosis. Therefore, we aimed to obtain patient feedback to guide successful trial design, recruitment, retention, and for identifying potential barriers to study participation. Methods Over 1000 members of an international laryngotracheal stenosis online support community (the Living with Idiopathic Subglottic Stenosis Facebook group) were sent two questionnaires for a proposed interventional double-blinded, randomized, placebo-controlled clinical trial. Results A total of 317 and 558 participants responded to the first and second surveys, respectively. The majority of participants (77%) were willing to consider enrollment, regardless of having a 50% chance of receiving placebo versus treatment (78%). The majority (84%) of participants were willing to travel 200 miles to participate for up to six in-person visits over 50 days. Specific side effects, including anemia/thrombocytopenia (72%) or risk of infection (69.3%) had the greatest impact on clinical trial participation with other side effects (peripheral edema (53%), oral ulcers (51%), and gastrointestinal side effects (41%)) having less impact. Conclusion Patients with laryngotracheal stenosis possess nuanced insight into their disease and treatment options. As a group, they are extremely motivated for better therapies. Future laryngotracheal stenosis clinical trials should focus on providing excellent side effect -related education and utilizing feedback from online advocacy groups to optimize recruitment and retention.

scholarly journals Making Telecare desirable rather than a last resort

2016 ◽  
Vol 38 (5) ◽  
pp. 926-953
Author(s):  
CLAIRE L. BENTLEY ◽  
LAUREN A. POWELL ◽  
ALISON ORRELL ◽  
GAIL A. MOUNTAIN
Keyword(s):  
Cost Benefit ◽  
Support Network ◽  
Structured Interviews ◽  
Framework Analysis ◽  
Preventative Measure ◽  
Peace Of Mind ◽  
The United Kingdom ◽  
The Individual ◽  
The Impact ◽  
Perceived Costs

ABSTRACTDespite reported benefits of Telecare use for older adults, uptake of Telecare in the United Kingdom remains relatively low. Non-users of Telecare are an under-researched group in the Telecare field. We conducted 22 qualitative individual semi-structured interviews to explore the views and opinions of current non-users of Telecare regarding barriers and facilitators to its use, and explored considerations which may precede their decision to accept, or reject, Telecare. Framework analysis identified a number of themes which influence the outcome and timing of this decision, including peace of mind (for the individual and their family), the strength and composition of an individual's support network, the impact of changing personal and health circumstances, and lack of communication about Telecare (e.g.advertising). A cost–benefit decision process appears to take place for the potential user, whereby the benefit of peace of mind is weighed against perceived ‘costs’ of using Telecare. Telecare is often perceived as a last resort rather than a preventative measure. A number of barriers to Telecare use need to be addressed if individuals are to make fully informed decisions regarding their Telecare use, and to begin using Telecare at a time when it could provide them with optimal benefit. Although the study was set in England, the findings may be relevant for other countries where Telecare is used.

Sign in / Sign up

Export Citation Format

Share Document