The challenges of clinical trials for adolescents and young adults with cancer

2008 ◽  
Vol 50 (S5) ◽  
pp. 1101-1104 ◽  
Author(s):  
Andrea Ferrari ◽  
Michael Montello ◽  
Troy Budd ◽  
Archie Bleyer
Keyword(s):  
Clinical Trials ◽  
Young Adults ◽  
Adolescents And Young Adults

scholarly journals The management of Hodgkin lymphoma in adolescents and young adults: burden of disease or burden of choice?

Blood ◽  
2018 ◽  
Vol 132 (4) ◽  
pp. 376-384 ◽  
Author(s):  
Jamie E. Flerlage ◽  
Monika L. Metzger ◽  
Nickhill Bhakta
Keyword(s):  
Overall Survival ◽  
Clinical Trials ◽  
Young Adults ◽  
Hodgkin Lymphoma ◽  
Burden Of Disease ◽  
Health Care Services ◽  
Survival Rates ◽  
Adolescents And Young Adults ◽  
Adult Health ◽  
Treatment Regimens

Abstract Adolescents and young adults (AYAs) comprise the largest age group affected by Hodgkin lymphoma (HL). Despite excellent overall survival of AYA patients with HL due to advances in treatment regimens, therapy-associated late effects continue to be a concern in HL survivors, especially for younger patients who have decades of life remaining. Since the first clinical trial for HL with chemotherapy in 1964, subsequent protocols have attempted to reduce chemotherapy-induced toxicities and yet maintain high overall survival rates. Today, new analytic methods applied to data from survivorship cohorts, such as the recently described cumulative burden of disease metric, can be used to inform changes for future protocols. Although pediatric and adult trial consortia have followed this process, the AYA population, an age cohort split between pediatric and adult health care services, faces many barriers to care and is the least likely to be enrolled in clinical trials. AYA patients with HL theoretically have a choice to be treated in pediatric or adult protocols when presented with these options. Recent efforts by the National Clinical Trials Network, the Children’s Oncology Group, and others have been made to ensure that the burden of choice for the AYA population is not greater than the burden of disease.

scholarly journals Improving recruitment and retention of adolescents and young adults with cancer in randomized controlled clinical trials

2019 ◽  
Vol 0 (0) ◽  
Author(s):  
Sharron L. Docherty ◽  
Stacey Crane ◽  
Joan E. Haase ◽  
Sheri L. Robb
Keyword(s):  
Clinical Trials ◽  
Young Adults ◽  
Randomized Clinical Trials ◽  
Adolescents And Young Adults ◽  
Adolescent And Young Adult ◽  
Recruitment And Retention ◽  
Randomized Controlled Clinical Trials ◽  
Pros And Cons ◽  
Adult Resilience ◽  
Psychosocial Programs

Abstract Participation of adolescents and young adults (AYAs) with cancer in randomized clinical trials (RCTs) is necessary to advance treatments and psychosocial programs. Exploring AYAs experiences in an RCT will inform strategies to support recruitment and retention. A qualitative design was used to study the experiences of 13 AYAs in the Stories and Music for Adolescent and Young Adult Resilience during Transplant I (SMART I) trial. Key themes included: Weighing the Pros and Cons; Randomization Preferences; Completing Measures; and Worthwhile Experience. The experiences of AYAs during RCTs can bring insights that inform the design and management of AYA trials. Strategies include improving assent/consent processes, design of electronic interfaces and encouraging researcher flexibility.

scholarly journals Conducting Psychosocial Intervention Research among Adolescents and Young Adults with Cancer: Lessons from the PRISM Randomized Clinical Trial

Children ◽  
2019 ◽  
Vol 6 (11) ◽  
pp. 117 ◽  
Author(s):  
Abby R. Rosenberg ◽  
Courtney C. Junkins ◽  
Nicole Sherr ◽  
Samantha Scott ◽  
Victoria Klein ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Young Adults ◽  
Psychosocial Intervention ◽  
Adolescents And Young Adults ◽  
Limited Participation ◽  
Study Staff ◽  
Content Analyses ◽  
Trial Testing ◽  
Field Notes

Background: Adolescents and young adults (AYAs) with cancer have poor psychosocial outcomes, in part because their limited participation in clinical trials precludes intervention-testing. We previously reported results of a successful randomized trial testing an AYA-targeted psychosocial intervention. Here, we aimed to describe strategies learned during the trial’s conduct. Methods: We summarized data from the medical record and staff field notes regarding reasons for participation/non-participation. We conducted two focus groups with study staff; directed content analyses identified strategies for success. Results: 92 AYAs enrolled (77% of approached; n = 50 Usual Care (control), n = 49 PRISM (intervention)). In eligible families who declined participation (n = 22 AYAs, n = 8 parents), the AYAs more commonly had advanced cancer (n = 11 (37%) declined vs. n = 25 (26%) enrolled). AYA reasons for non-enrollment were predominantly “not interested”; parents worried participation was “too burdensome.” Staff strategies for accrual included having significant time to introduce the study and underscoring a desire to learn from the patient. After enrollment, AYAs who discontinued participation were more commonly assigned to control (n = 5 (10%) control vs. n = 2 (4%) intervention). Only n = 1 AYA chose to discontinue participation after receiving the intervention. Conclusions: Efforts to engage AYAs prior to and during studies may help with accrual and retention.

scholarly journals Evaluation of Adolescents’ and Young Adults’ Attitudes Toward Participation in Cancer Clinical Trials

2020 ◽  
Vol 16 (3) ◽  
pp. e280-e289
Author(s):  
Jeremy Lewin ◽  
Jennifer A. H. Bell ◽  
Kate Wang ◽  
Victoria Forcina ◽  
Seline Tam ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Young Adults ◽  
Logistic Regression ◽  
Adolescents And Young Adults ◽  
Cancer Clinical Trials ◽  
Patient Centered ◽  
Logistic Regression Models ◽  
Age Related ◽  
Tumor Types

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.

scholarly journals Accrual of adolescents and young adults with cancer to clinical trials

2016 ◽  
Vol 23 (2) ◽  
pp. 81 ◽  
Author(s):  
A.E. Hay ◽  
C. Rae ◽  
G.A. Fraser ◽  
R.M. Meyer ◽  
L.S. Abbott ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Young Adults ◽  
Adolescents And Young Adults

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Use of Communication Technology to Improve Clinical Trial Participation in Adolescents and Young Adults With Cancer: Consensus Statement From the Children's Oncology Group Adolescent and Young Adult Responsible Investigator Network

2021 ◽  
Author(s):  
Viswatej Avutu ◽  
Varun Monga ◽  
Nupur Mittal ◽  
Aniket Saha ◽  
Jeffrey R. Andolina ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Young Adults ◽  
Consensus Statement ◽  
Adolescents And Young Adults ◽  
Trial Participation ◽  
Cancer Clinical Trials ◽  
Oncology Group ◽  
Tumor Boards ◽  
Remote Patient

Adolescents and young adults (AYAs; age 15-39 years) with cancer are under-represented in cancer clinical trials because of patient, provider, and institutional barriers. Health care technology is increasingly available to and highly used among AYAs and has the potential to improve cancer care delivery. The COVID-19 pandemic forced institutions to rapidly adopt novel approaches for enrollment and monitoring of patients on cancer clinical trials, many of which have the potential for improving AYA trial participation overall. This consensus statement from the Children's Oncology Group AYA Oncology Discipline Committee reviews opportunities to use technology to optimize AYA trial enrollment and study conduct, as well as considerations for widespread implementation of these practices. The use of remote patient eligibility screening, electronic informed consent, virtual tumor boards, remote study visits, and remote patient monitoring are recommended to increase AYA access to trials and decrease the burden of participation. Widespread adoption of these strategies will require new policies focusing on reimbursement for telehealth, license portability, facile communication between electronic health record systems and advanced safeguards to maintain patient privacy and security. Studies are needed to determine optimal approaches to further incorporate technology at every stage of the clinical trial process, from enrollment through study completion.

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