Improving recruitment and retention of adolescents and young adults with cancer in randomized controlled clinical trials.
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ABSTRACT:
SUBMITTER: Docherty SL
PROVIDER: S-EPMC7048696 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundAlthough the majority of American Indians/Alaska Natives reside in urban areas, there are very few randomized controlled trials analyzing culturally centered substance use prevention interventions for this population.MethodsWe describe methods employed to recruit and retain urban American Indian/Alaska Native adolescents into a randomized controlled trial, which was focused on testing the potential benefits of a substance use prevention intervention for this population. We also report challenges encountered in recruitment and retention of participants and strategies employed addressing these challenges. Data collection occurred from August 2014 to October 2017.ResultsWe partnered with two community-based organizations in different cities in California. We utilized American Indian/Alaska Native recruiters from communities, placed flyers in community-based organizations, and asked organizations to post flyers on their web and social media sites. We also offered gift cards for participants. Our initial recruitment and retention model was moderately successful; however, we encountered five main challenges: (1) transportation, (2) increasing trust and interest, (3) adding research sites, (4) getting the word out about the project, and (5) getting youth to complete follow-up surveys. Strategies employed to overcome transportation challenges included shortening the number of sessions, offering sessions on both weekends and weekdays, and increasing bus tokens and transportation options. We hired more staff from American Indian/Alaska Native communities, added more research sites from our previously established relationships, and were more proactive in getting the word out on the project in American Indian/Alaska Native communities. We also utilized more field tracking and emailed and mailed survey invitations to reach more participants for their follow-up surveys. Because of our efforts, we were nearly able to reach our initial recruitment and retention goals.ConclusionAlthough our research team had previously established relationships with various urban American Indian/Alaska Native communities, we encountered various recruitment and retention challenges in our study. However, by identifying challenges and employing culturally appropriate strategies, we were able to collect valuable data on the potential effectiveness of a substance use prevention intervention for urban American Indian/Alaska Native adolescents. Findings from this study assist toward the development of potentially successful strategies to successfully recruit and retain urban American Indian/Alaska Native adolescents in randomized controlled trials.
| S-EPMC7878293 | biostudies-literature
Project description:OBJECTIVES:We examined long-term prescription drug misuse outcomes in 3 randomized controlled trials evaluating brief universal preventive interventions conducted during middle school. METHODS:In 3 studies, we tested the Iowa Strengthening Families Program (ISFP); evaluated a revised ISFP, the Strengthening Families Program: For Parents and Youth 10-14 plus the school-based Life Skills Training (SFP 10-14 + LST); and examined the SFP 10-14 plus 1 of 3 school-based interventions. Self-reported outcomes were prescription opioid misuse (POM) and lifetime prescription drug misuse overall (PDMO). RESULTS:In study 1, ISFP showed significant effects on POM and PDMO, relative reduction rates (RRRs; age 25 years) of 65%, and comparable benefits for higher- and lower-risk subgroups. In study 2, SFP 10-14 + LST showed significant or marginally significant effects on POM and PDMO across all ages (21, 22, and 25 years); higher-risk participants showed stronger effects (RRRs = 32%-79%). In study 3, we found significant results for POM and PDMO (12th grade RRRs = 20%-21%); higher-risk and lower-risk participants showed comparable outcomes. CONCLUSIONS:Brief universal interventions have potential for public health impact by reducing prescription drug misuse among adolescents and young adults.
| S-EPMC3673263 | biostudies-literature
Project description:BACKGROUND:Recruitment and retention strategies for patient-centered outcomes research are evolving and research on the subject is limited. In this work, we present a conceptual model of patient-centered recruitment and retention, and describe the recruitment and retention activities and related challenges in a patient-centered comparative effectiveness trial. METHODS:This is a multicenter, longitudinal randomized controlled trial in localized prostate cancer patients. RESULTS:We recruited 743 participants from three sites over 15 months period (January 2014 to March 2015), and followed them for 24 months. At site 1, of the 773 eligible participants, 551 (72%) were enrolled. At site 2, 34 participants were eligible and 23 (68%) enrolled. Of the 434 eligible participants at site 3, 169 (39%) enrolled. We observed that strategies related to the concepts of trust (e.g., physician involvement, ensuring protection of information), communication (e.g., brochures and pamphlets in physicians' offices, continued contact during regular clinic visits and calling/emailing assessment), attitude (e.g., emphasizing the altruistic value of research, positive attitude of providers and research staff), and expectations (e.g., full disclosure of study requirements and time commitment, update letters) facilitated successful patient recruitment and retention. A stakeholders' advisory board provided important input for the recruitment and retention activities. Active engagement, reminders at the offices, and personalized update letters helped retention during follow-up. Usefulness of telephone recruitment was site specific and, at one site, the time requirement for telephone recruitment was a challenge. CONCLUSIONS:We have presented multilevel strategies for successful recruitment and retention in a clinical trial using a patient-centered approach. Our strategies were flexible to accommodate site-level requirements. These strategies as well as the challenges can aid recruitment and retention efforts of future large-scale, patient-centered research studies. TRIAL REGISTRATION:Clinicaltrials.gov , ID: NCT02032550 . Registered on 22 November 2013.
| S-EPMC5870194 | biostudies-literature
Project description:BackgroundThe 18-year-old age limit for inclusion in clinical trials constitutes a hurdle for adolescents and young adults (AYAs) with cancer. We analyzed the impact of this age barrier on the access of AYAs to cancer trials and novel therapies.MethodsClinicalTrials.gov was searched to identify all the trials including patients with 10 malignancies relevant for AYAs (January 2007 to July 2018). The trials were categorized as pediatric (patients <18 y), adult (≥18 y), and transitional (including adult and pediatric patients). Transitional trials with a lower limit between 12 and 18 years and an upper limit younger than 40 years were considered AYA-specific.ResultsOf 2764 identified trials, 2176 were included: 79% adult, 19% transitional, 2% pediatric. Five trials were AYA-specific. The proportion of academic trials was higher for transitional (69%; 288 of 421) than for adult trials (48%; 832 of 1718) (P < .0001). The total number of new trials increased over the years (156 in 2007; 228 in 2017); however, the number of transitional trials remained stable. The availability of trials increased with age, with a major increase at age 18 years: at age 17 years, 20% (442 of 2176) of trials were potentially accessible vs 95% (2075 of 2176) at 18 years. For trials investigating targeted therapies, this increase was 460% (197 trials available at age 17 years; 901 at 18 years) and for immunotherapies, 1200% (55 at age 17 years; 658 at 18 years).ConclusionsAYAs have limited access to cancer trials and innovative therapies, with no improvement over the last decade. The 18-years-old age limit continues to be a major hurdle. Our findings are consistent with the internationally supported idea that age inclusion criteria in oncological trials should be changed.
| S-EPMC7050014 | biostudies-literature
Project description:Adolescent and young adult (AYA) enrollment in cancer clinical trials (CCT) is suboptimal. Few studies have explored site level barriers and facilitators to AYA enrollment on CCTs and the efficacy of interventions to enhance enrollment. A cross sectional survey was developed by the COG AYA Oncology Discipline Committee Responsible Investigator (RI) Network to identify perceived barriers and facilitators to enrollment, as well as opportunities to improve enrollment. Associations of barriers and facilitators to enrollment with program demographics were assessed. The survey was sent to all AYA RI Network members (n = 143) and quantitative and thematic analyses were conducted. The overall response rate was 42% (n = 60/143). Participants represented diverse institutions based on size, presence or absence of dedicated AYA programs, and proximity and relationship between pediatric and medical oncology practices within the institution. The most frequently cited barriers to enrolling AYAs in CCTs were administrative logistical issues (45%), disparate enrollment practices (42%) and communication issues (27%) between pediatric and medical oncology and perceived limited trial availability (27%). The most frequently reported facilitators to enrollment included having strong communication between pediatric and medical oncology (48%), having a supportive research infrastructure (35%) and the presence of AYA champions (33%). Many barriers and facilitators were similar across institutions and AYA program types. Shared barriers and facilitators to AYA CCT enrollment exist across the landscape of cancer care settings. Interventions aimed at increasing coordination between pediatric and medical oncology clinical trials offices and providers have high potential to improve site-level AYA enrollment.
| S-EPMC8907177 | biostudies-literature
Project description:Background and purposeThe National Institutes of Health policy calls for the inclusion of under-represented groups, such as women and minorities, in clinical research. Poor minority recruitment and retention in stroke clinical trials remain a significant challenge limiting safety and efficacy in a general population. Previous research examines participant barriers to clinical trial involvement, but little is known about the investigator perspective. This study addresses this gap and examines researcher-reported barriers and best practices of minority involvement in stroke clinical trials.MethodsQuantitative and qualitative methods, including surveys, focus groups, and key informant interviews were used.ResultsIn a survey of 93 prominent stroke researchers, 43 (51.2%; 70% response rate) respondents reported proactively setting recruitment goals for minority inclusion, 29 respondents (36.3%) reported requiring cultural competency staff training, and 44 respondents (51.2%) reported using community consultation about trial design. Focus groups and key informant interviews highlighted structural and institutional challenges to recruitment of minorities, including mistrust of the research/medical enterprise, poor communication, and lack of understanding of clinical trials. Researcher-identified best practices included using standardized project management procedures and protocols (eg, realistic budgeting to support challenges in recruitment, such as travel/parking reimbursement for participants), research staff cultural competency and communication training, and developing and fostering community partnerships that guide the research process.ConclusionsThis study's formative evaluation contributes a new dimension to the literature as it highlights researcher-reported barriers and best practices for enhancing participation of minority populations into stroke clinical trials.
| S-EPMC5526461 | biostudies-literature
Project description:In the United States, adolescent and young adult (AYA) patients with cancer have the lowest clinical trial participation rate of all age groups and slower progress in survival improvement than younger patients. Ominously, AYA clinical trial participation has been steadily decreasing since 2010, except in 15-19 year olds and AYAs with acute lymphoblastic leukemia. In order to reverse the accrual trend, multiple changes are necessary, including convincing community oncologists to pursue clinical trials on behalf of their AYA patients and to have the new National Community Oncology Research Program and National Clinical Trials Network lead a coordinated effort to increase accrual.
| S-EPMC6077840 | biostudies-other
Project description:BackgroundParenting programs are well established as an effective strategy for enhancing both parenting skills and the well-being of the child. However, recruitment for family programs in clinical and nonclinical settings remains low.ObjectiveThis study aims to describe the recruitment and retention methods used in a text messaging program (MyTeen) trial for parents of adolescents (10-15 years) and identify key lessons learned. We aim to provide insights and direction for researchers who seek to recruit parents and build on the limited literature on recruitment and retention strategies for parenting program trials.MethodsA recruitment plan was developed, monitored, and modified as needed throughout the course of the project. Strategies to facilitate recruitment were identified (eg, program content and recruitment material, staff characteristics, and study procedures). Traditional and web-based recruitment strategies were used.ResultsOver a 5-month period, 319 parents or caregivers expressed interest in our study, of which 221 agreed to participate in the study, exceeding our recruitment target of 214 participants. Attrition was low at the 1-month (4.5% overall; intervention group: n=5, 4.6%; control group: n=5, 4.5%) and 3-month follow-ups (9% overall; intervention group: n=10, 9.2%; control group: n=10, 8.9%).ConclusionsThe use of web-based recruitment strategies appeared to be most effective for recruiting and retaining parents in a text-messaging program trial. However, we encountered recruitment challenges (ie, underrepresentation of ethnic minority groups and fathers) similar to those reported in the literature. Therefore, efforts to engage ethnic minorities and fathers are needed.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12618000117213; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374307.
| S-EPMC8726057 | biostudies-literature
Project description:IntroductionRecruitment is essential for the success of clinical trials. We are conducting a randomized clinical trial to test the effect of a Mediterranean dietary intervention with or without 1700 mg/day of metformin for the prevention of age-related chronic diseases, the MeMeMe trial (Trial registration number: EudraCT number: 2012-005427-32 ClinicalTrials.gov ID: NCT02960711). MeMeMe recruiting experience, highlighting strengths, limitations encountered and results is reported.Patients and methodsStatistical analysis focused on the reasons for withdrawal according to the recruitment method ("active" versus "passive" criterion) and the time of withdrawal. Logistic regression models were used to explore the associations between the risk of withdrawal and sex, recruitment method, randomization arm, and with markers of compliance to the intervention, such as one-year change in body weight.ResultsOut of 2035 volunteers, 660 (32.4%) were recruited "actively" and 1375 (67.6%) "passively". Among people who dropped out of the trial after randomization, there were 19.5% for the "active" and 22.0% for the "passive" method (p = 0.28). The risk of withdrawal was significantly higher in women (OR:1.91; 95% CI:1.17-3.12; p = 0.01), in volunteers older at recruitment (OR:1.25; 95% CI:1.07-1.45; p = 0.004), and in those with a higher BMI at baseline (OR:1.23; 95% CI:1.07-1.43; p = 0.004). Volunteers who lost at least 2 kg (the median weight change) in the first year of intervention were significantly less (53%) likely to withdraw from the trial (OR:0.48; 95% CI:0.30-0.75; p = 0.001).ConclusionOur findings suggest that the "passive" recruitment method was more effective than the "active" one to advance recruitment. The benefits of "passive" recruitment hardly outweighed the drawbacks.Trial registrationTrial registration number: EudraCT number: 2012-005427-32. ClinicalTrials.gov ID: NCT02960711.
| S-EPMC8956174 | biostudies-literature
Project description:BackgroundObservational studies suggest that some patients meeting criteria for ARDS no longer fulfill the oxygenation criterion early in the course of their illness. This subphenotype of rapidly improving ARDS has not been well characterized. We attempted to assess the prevalence, characteristics, and outcomes of rapidly improving ARDS and to identify which variables are useful to predict it.MethodsA secondary analysis was performed of patient level data from six ARDS Network randomized controlled trials. We defined rapidly improving ARDS, contrasted with ARDS > 1 day, as extubation or a Pao2 to Fio2 ratio (Pao2:Fio2) > 300 on the first study day following enrollment.ResultsThe prevalence of rapidly improving ARDS was 10.5% (458 of 4,361 patients) and increased over time. Of the 1,909 patients enrolled in the three most recently published trials, 197 (10.3%) were extubated on the first study day, and 265 (13.9%) in total had rapidly improving ARDS. Patients with rapidly improving ARDS had lower baseline severity of illness and lower 60-day mortality (10.2% vs 26.3%; P < .0001) than ARDS > 1 day. Pao2:Fio2 at screening, change in Pao2:Fio2 from screening to enrollment, use of vasopressor agents, Fio2 at enrollment, and serum bilirubin levels were useful predictive variables.ConclusionsRapidly improving ARDS, mostly defined by early extubation, is an increasingly prevalent and distinct subphenotype, associated with better outcomes than ARDS > 1 day. Enrollment of patients with rapidly improving ARDS may negatively affect the prognostic enrichment and contribute to the failure of therapeutic trials.
| S-EPMC6414787 | biostudies-literature