Educational Program for Clinical Trial Participation in Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Colorado, Denver
Disqualifiers: Non-English/Spanish, Cognitive impairment, Vulnerable populations, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
This proposal aims to leverage ongoing community outreach efforts and the Cancer Center's aims to improve recruitment to clinical trials by educating the catchment and making referrals to engage current UCCC patients not taking advantage of available CTs at this institution and affiliated hospitals. The Cancer Prevention and Control Program within UCCC works to develop and evaluate novel approaches to primary prevention, disseminate preventative interventions in population-based settings, and to improve health services delivery and outcomes for cancer patients and survivors. A primary emphasis is placed on those from underrepresented populations, including Hispanics, residents of outlying rural areas, and those in areas of poverty. Efforts to meet the Cancer Center's priorities include interventions to promote awareness and recruitment of eligible patients to available CTs in the catchment area (the state of Colorado).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Educational Intervention, PRE-ACT Model, Patient Navigator Model for clinical trial participation in cancer?
Research shows that educational programs and patient navigation can improve understanding and decision-making about clinical trials. For example, a study with Latina breast cancer patients found that a similar intervention increased their understanding and consideration of clinical trials as a treatment option.12345
Is the educational program for clinical trial participation in cancer safe for humans?
The research articles reviewed do not provide specific safety data for the educational program itself, but they do indicate that the interventions, such as decision support tools and patient navigation, were well-received and showed positive outcomes in terms of understanding and decision-making without mentioning any safety concerns.12678
How does this treatment differ from other cancer treatments?
This treatment is unique because it involves an educational program using patient navigators to help increase participation in cancer clinical trials, especially among minorities. Unlike traditional treatments, it focuses on overcoming barriers to trial enrollment and providing support and education to patients.910111213
Eligibility Criteria
This trial is for adults over 18 who speak English or Spanish and are part of underrepresented populations in Colorado. They must be willing to learn about clinical trials, consent to participate, and be available throughout the study. It excludes non-English/Spanish speakers, decisionally-challenged individuals, vulnerable groups like inmates or homeless people, and anyone under 18.Inclusion Criteria
I speak English or Spanish.
I am willing and able to follow all study rules and attend all appointments.
Stated willingness to comply with all study procedures and be available for the duration of the study
See 2 more
Exclusion Criteria
I am under 18 years old.
I speak English or Spanish and meet all other eligibility criteria.
I am able to make decisions for myself and am not impaired by substances or cognitive issues.
See 1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Educational Intervention
Community Health Educators conduct workshops to educate participants about the importance of participating in cancer clinical trials.
1 week
1 visit (in-person)
Referral and Tracking
Patient Navigators set up communication pathways and track referrals to clinical trials.
36 months
Follow-up
Participants are monitored for changes in knowledge and understanding of clinical trials and their participation.
36 months
Treatment Details
Interventions
- Educational Intervention (Behavioral Intervention)
Trial OverviewThe trial tests an educational intervention designed to increase awareness and participation in clinical trials among underrepresented communities. The focus is on Hispanics, rural residents, and those living in poverty within Colorado's catchment area.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Underrepresented PopulationExperimental Treatment1 Intervention
A primary emphasis is placed on those from underrepresented populations, including Hispanics, residents of outlying rural areas, and those in areas of poverty
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Colorado HospitalAurora, CO
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Who Is Running the Clinical Trial?
University of Colorado, DenverLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Empowering Latina breast cancer patients to make informed decisions about clinical trials: a pilot study. [2021]Minority representation in clinical trials is vital for researchers to assess differential effects in outcomes of therapies on biological and genetic characteristics among groups. This study assessed the effect of Choices, a bilingual multi-component intervention, on perceived understanding of clinical trials, agreement with stages of decision readiness and consideration of clinical trials as a treatment option, among Latina breast cancer patients. This randomized controlled pilot study compared Choices with a control condition providing general clinical trial information to eligible patients. Seventy-seven Latina breast cancer patients were randomly assigned to either Choices (n = 38) or the control (n = 39). Choices included three components: an educational interactive video, a low-literacy booklet, and care coordination by patient navigation (i.e., educational and psychosocial support, coordinating appointments, translating, interacting with the medical team). Choices was more effective than the control in improving perceived understanding of clinical trials (p = .033) and increasing consideration of clinical trials as a treatment option (p = .008). Additionally, intervention participants showed significant changes between baseline and post-intervention on agreement with stages of decision readiness statements (p .05); the percentage of intervention women in agreement with preparation to action statements increased from 52.8% at baseline to 86.1% at post-intervention, and those in agreement with ready to action stages rose from 50.0% to 88.9%. Computer-based videos and care coordination provided by patient navigation-specifically tailored to Latinos-are effective strategies to successfully address awareness, and improved decision-making skills to make informed decisions about clinical trial participation.
Statewide cancer clinical trial navigation service. [2022]Realizing that education and awareness are paramount in making clinical trials available to improve overall accrual rates, we sought to create a clinical trial navigation service to improve the accessibility of cancer clinical trials in Florida for physicians and patients. This study was undertaken to evaluate this service. We hoped to identify characteristics of our service that were effective in promoting clinical trial enrollment and to better understand barriers that prevented enrollment.
"The promise of community-based advocacy and education efforts for increasing cancer clinical trials accrual". [2022]Only 3% of cancer patients participate in cancer clinical trials (CCTs). A number of barriers to participation, particularly for minority groups, can be addressed through community-focused education and advocacy efforts. Working with community partnerships, a pilot program sought to change knowledge, attitudes, and role behaviors among community leaders, primary care providers (PCPs), and clinical researchers about CCTs, to increase patient awareness of and participation in CCTs. A mixed method evaluation utilized quantitative analysis of surveys administered to participants during the program period (2006-2008) and qualitative data from interviews with key participants. Programmatic efforts were effective in increasing knowledge and training community leaders and PCPs to disseminate messages about clinical trials, and ultimately increasing patient inquiries about local trials. Training improved cultural competency skills among clinical researchers to recruit and retain CCT participants. Partnerships fostered new processes and structures to facilitate CCT participation in their communities. Clinical trials education and advocacy efforts through community partnerships have an important role in enhancing clinical trial access and in increasing clinical trial participation. Oncologists' involvement in and leadership of such partnerships are critical to promoting CCT accrual, particularly for minority groups.
Evaluating a community-partnered cancer clinical trials pilot intervention with African American communities. [2022]Cancer clinical trial (CCT) accrual and retention rates remain disproportionately low among African Americans. Awarenesss and access to trials are crucial facilitators of trial participation. Strategies developed within a community-based participatory framework (CBPR) are potential solutions to increase awareness and access to CCTs. In this study, we describe the pilot phase of three innovative community-centered modules to improve basic CCT knowledge, awareness of locations to access CCT information, and opportunities to participate in CCTs. Four community organizations completed Community Bridges to CCT training-of-the-trainer and recruited adult African American volunteers to participate in one of three CCT education modules: a workshop about CCTs, a role play describing one person's experience with CCTs, or a call and response session reviewing myths and facts about CCTs. Pre- and post-test surveys were collected and analyzed using McNemar agreement statistic to evaluate changes in knowledge and attitudes regarding trials. Trainers enrolled 125 participants in the call and response (n = 22), role play (n = 60), and workshop (n = 43) modules. Module participants were mostly African American, female, and with a mean age of 53 years. Comparison of pre- and post-test responses demonstrates favorable changes in awareness of CCTs and where to access CCTs across the sample. Analysis by module type indicates significant increases for participants in the call and response (p
A lay patient navigation training curriculum targeting disparities in cancer clinical trials. [2022]African-Americans experience a disproportionate share of thoracic cancer burden compared to Whites. Low socioeconomic status (SES) and race are factors in low clinical trial enrollment, accounting for the disparities between African-Americans and Whites. Less than 3% of newly diagnosed cancer patients enroll in clinical trials, and of that number, only 10% represent ethnic minorities. The value of clinical trials research is not generalizable without sufficient representation by ethnic minorities. Patient navigation, an intervention designed to ensure timely and efficient access to healthcare, may improve clinical trial enrollment among African-Americans in lung and esophageal trials by influencing a patient's perception of clinical trials. The lack of navigation programs and training may negatively influence standardization of navigation techniques. The purpose of this project was to deliver and evaluate an evidence-based navigation-training curriculum for "lay" navigators. The primary outcomes measured were confidence in the role as navigator, understanding a navigator's role, and knowledge and perception of clinical trials. The results revealed overall confidence in the role as lay navigators increased from pre-to-post test. Lessons learned included the need for preparatory classes to build the navigator's confidence, and additional training components in death and dying. A larger study is warranted to confirm the findings.
Development of a Plain Language Decision Support Tool for Cancer Clinical Trials: Blending Health Literacy, Academic Research, and Minority Patient Perspectives. [2022]Despite the promise of clinical trials for improving cancer care, less than 5% of all cancer patients participate. Racial/ethnic minorities continue to be underrepresented in cancer clinical trials (CCTs). To address this gap, we developed a plain language, web-based decision support tool (CHOICES DST) in English and Spanish to support decision-making about CCTs among Blacks and Hispanics. In phase 1 (information collection), we conducted qualitative interviews with 45 cancer patients, completed a thorough literature review, and reviewed results from a telephone survey of 1100 cancer patients. In phase 2 (content generation), we created the first iteration of the CHOICES DST. In phase 3 (usability testing), we gathered user experience and acceptability data from a small sample of cancer survivors (n = 9). The Knowledge, Empowerment, and Values Clarification (KEV) model of decision-making was developed based on data from phase 1. The KEV model and other phase 1 data allowed us to create the CHOICES DST platform. Usability testing of the CHOICES DST showed highly favorable responses from users, satisfaction with content, ease of navigation, and a desire to use the tool. Qualitative results identified addressable points that would benefit from content and navigation-related alterations. The final version of the CHOICES DST was well received and understood by Black and Hispanic participants, and adheres to the mandates for plain language communication. This research provides preliminary data that CHOICES DST holds promise for improving knowledge of CCTs and potentially improving informed decision-making about participation in trials.
Discussing randomised clinical trials of cancer therapy: evaluation of a Cancer Research UK training programme. [2022]To evaluate a training intervention aimed at improving healthcare professionals' communication with cancer patients about randomised clinical trials.
The Impact of an Online Training Program About Cancer Clinical Trials on Primary Care Physicians' Knowledge, Attitudes and Beliefs, and Behavior. [2022]Participation in cancer clinical trials (CCTs) is critical to improving cancer treatments and quality of care. However, rates of patient participation remain low. Research has shown that a trusted physician recommendation is an important influence on patients' decisions to enroll in a CCT. Improving primary care providers' (PCPs') knowledge, attitudes, and beliefs about CCTs is a promising potential path for improving CCT participation. The aim of this pilot study was to test the effect of an online educational course for PCPs about clinical trials on primary care providers' knowledge, attitudes and beliefs, and behavior. Forty-one PCPs in the New York City area participated in a 1-h online training session on cancer clinical trials. These PCPs had self-selected to complete the training in a previous survey. The objectives of the training module were to (1) educate the PCPs about clinical trials, with a focus on overcoming misconceptions; and (2) discuss roles of PCPs in partnering with oncologists to help patients gain access to clinical trials. The training module included didactics, audio excerpts, and case descriptions. Participants completed a pre-test immediately before taking the course, a post-test immediately after taking the course, and a 3-month post-course survey. All three assessments included a general T/F knowledge test, a 7-item attitude/belief scale, and a knowledge test focused specifically on local resources and access for clinical trials. Forty-one PCPs completed the module and the pre-post course surveys. Eighty percent (33/41) also completed the 3-month post-course survey. General knowledge and local knowledge increased significantly (p
Effectiveness of a Lay Navigation Program in an Academic Cancer Center. [2021]A navigation program with lay navigators that targets patients with cancer who are receiving multiple treatment modalities was launched with the goal of improving care coordination.
Patient Navigation As a Model to Increase Participation of African Americans in Cancer Clinical Trials. [2022]Less than 10% of patients enrolled in clinical trials are minorities. The patient navigation model has been used to improve access to medical care but has not been evaluated as a tool to increase the participation of minorities in clinical trials. The Increasing Minority Participation in Clinical Trials project used patient navigators (PNs) to enhance the recruitment of African Americans for and their retention in therapeutic cancer clinical trials in a National Cancer Institute-designated comprehensive cancer center.
A national patient navigator training program. [2021]Patient Navigation is an intervention aimed at addressing cancer health disparities by eliminating barriers to diagnosis, treatment, and services. Three major patient navigation (PN) programs (The National Cancer Institute, The American Cancer Society &The Center for Medicare and Medicaid Services) are underway to address the needs of medically underserved cancer patients. There has not been national training with a defined curriculum for patient navigators (PNs). Curriculum for training the PNs was created by experts from the three programs. The efficacy of training was evaluated using a pre- and posttest. The data show that overall the posttest scores improved from the pretest. In addition, having a high school education or greater or having more years of work experience were significantly related to improvements on the posttest. The first successful standardized national training program was attended by 116 PNs representing 85 cities with the goal to reduce health disparities for medically underserved.
Bridging the healthcare divide with patient navigation: development of a research program to address disparities. [2021]Americans who live in poverty as well as certain ethnic and racial groups have higher cancer death rates than other populations. Patient navigators have been identified as an important weapon against these disparities. Navigators can address insurance, financial, and logistical issues (e.g., transportation, appointment scheduling, child or elder care). They can provide understandable health education that may lessen fears of cancer diagnosis and treatment. This article describes the development and implementation of a multisite patient navigator program involving five cancer institutions in Western Pennsylvania. Navigator programs have great potential to enhance cancer care by reaching underserved populations and opening the door for future research.
Patient participation in cancer clinical trials: A pilot test of lay navigation. [2023]Clinical trials (CT) represent an important treatment option for cancer patients. Unfortunately, patients face challenges to enrolling in CTs, such as logistical barriers, poor CT understanding and complex clinical regimens. Patient navigation is a strategy that may help to improve the delivery of CT education and support services. We examined the feasibility and initial effect of one navigation strategy, use of lay navigators.