Educational Tools for Cancer Clinical Trial Awareness

Overseen By Anna Moreno

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Under 18, Prior trial participation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

581 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to develop and pilot test a multi-communication approach to improve informed decision-making about cancer Clinical Trials (CTs) participation by increasing awareness of CTs and Mays Cancer Center (MCC) services (treatment care capacities, reputation and resources), positive attitudes towards CTs, self-efficacy and intentions to consider CTs as an appropriate treatment option for cancer (intention to participate) among patients attending the MCC (clinic-based setting) and the general public in selected Bexar County areas (community-based settings).

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems unlikely since the trial focuses on educational tools and awareness, not on testing a new treatment.

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 idea that Educational Tools for Cancer Clinical Trial Awareness is an effective treatment?

The available research does not provide specific data on the effectiveness of Educational Tools for Cancer Clinical Trial Awareness. The articles focus on patient-centered outcomes and the importance of involving patients in research, but they do not directly address the effectiveness of these educational tools in increasing awareness or participation in cancer clinical trials. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for increasing cancer clinical trial awareness?

Research highlights the importance of patient-centered outcomes and engaging stakeholders in the research process, which can improve the relevance and actionability of information provided to patients. This approach can enhance patients' understanding and decision-making regarding cancer clinical trials. ^{1 2 3 4 5}

What safety data exists for the educational tools used in cancer clinical trials?

The provided research does not directly address safety data for educational tools like Brochure, Clinical Trial Educational Video, Clinical Trial Fact Sheet, or Navigator. The articles focus on adverse event reporting and safety in drug trials, not educational tools. Therefore, specific safety data for these educational tools is not available in the given research. ^{6 7 8 9 10}

Is the treatment in the trial 'Educational Tools for Cancer Clinical Trial Awareness' promising?

Yes, the treatment is promising because educational tools like videos, booklets, and animations can increase awareness and knowledge about clinical trials. This can help more people, including those from minority groups, understand and consider participating in clinical trials, which are important for improving cancer treatments. ^{11 12 13 14 15}

How does this treatment differ from other cancer treatments?

This treatment is unique because it focuses on using educational tools like videos, booklets, and animations to increase awareness and understanding of clinical trials among cancer patients, which can lead to higher participation rates. Unlike traditional treatments that focus on medical interventions, this approach aims to empower patients with knowledge to make informed decisions about participating in clinical trials. ^{11 12 13 14 15}

Research Team

Amelie G Ramirez, DrPH, MPH

Principal Investigator

UT Health San Antonio

Patricia Chalela, DrPH, MPH

Principal Investigator

UT Health San Antonio

Eligibility Criteria

This trial is for newly diagnosed cancer patients at the Mays Cancer Center who haven't yet discussed treatment options with their doctor and have never been in a clinical trial. Participants must be adults able to consent and speak English or Spanish.

Inclusion Criteria

I haven't discussed treatment options with my doctor yet.

I speak English or Spanish.

Able to provide informed consent

Exclusion Criteria

You have previously taken part in a clinical trial.

I am under 18 years old.

Patients who have already had a consultation with their doctor to discuss treatment options

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive educational materials and support to improve informed decision-making about cancer clinical trial participation

3 months

Multiple sessions (in-person and virtual)

Follow-up

Participants are monitored for changes in knowledge, attitudes, and intentions regarding clinical trial participation

3 months

Treatment Details

Interventions

• Brochure
• Clinical Trial Educational Video
• Clinical Trial Fact Sheet
• Navigator

Trial Overview The study tests a multi-communication approach, including an educational video, fact sheet, brochure, and navigator support to help people make informed decisions about joining cancer clinical trials.

Participant Groups

Group I: Intervention Group Active Control 3 Interventions

Participants in the intervention group will receive 3 components: 1) a bilingual, culturally tailored clinical trial educational video, 2) a low literacy booklet, and 3) support from a patient navigator to empower cancer patients to make informed decisions about cancer clinical trial participation by increasing awareness of clinical trials and MCC services, positive attitudes and intentions to consider clinical trials as an appropriate treatment option for cancer.

Group II: Usual Care Control Group Active Control 1 Intervention

Participants in the usual care control group will receive a general clinical trial fact sheet.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Findings from Research

Establishing clinically meaningful outcomes in cancer clinical trials is crucial for enhancing the value of cancer care, as it guides research in trial design and effectiveness.

This approach emphasizes the importance of incorporating patient preferences and health outcomes, which can be analyzed through data from both clinical trials and real-world practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moving from evaluation to value in cancer care. Schilsky, RL.[2018]

The study successfully developed and implemented virtual education modules on care coordination and mental health for outpatient dialysis facilities, reaching over 2,500 facilities and impacting more than 179,000 patients in 2022.

Training significantly increased the knowledge of approximately 40,000 dialysis staff regarding patient-centered outcomes research, demonstrating the efficacy of the dissemination approach in improving patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Care Coordination and Mental Health Research Into Dialysis Practice: Stakeholder Perspectives, Methods, and Outcomes. Paulus, AB., Wendte, JM., Vinson, B.[2023]

A review of 56 articles and interviews with research organizations revealed that effective stakeholder engagement in research prioritization often combines in-person methods with structured ranking processes like Delphi, enhancing the relevance of research outcomes.

Challenges were noted in engaging the public and policymakers, highlighting the need for clearer terminology and consistent practices in stakeholder involvement to improve the effectiveness of comparative effectiveness research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A practice-based tool for engaging stakeholders in future research: a synthesis of current practices. Guise, JM., O'Haire, C., McPheeters, M., et al.[2016]

Patients with cancer need to be informed about outcomes that matter to them, such as quality of life and functional abilities, in addition to traditional disease-focused outcomes.

Current oncologic studies often lack sufficient reporting on these patient-centred outcomes, highlighting the need for a shift towards a more patient-focused approach in cancer care and research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patient or disease in oncology?] Hamaker, ME., Seghers, PALN., van Huis-Tanja, LH.[2021]

The virtual pilot training program significantly improved perceived PCOR knowledge among 59 participants (28 patients/caregivers and 31 researchers/providers) in the cystic fibrosis community, particularly regarding engagement levels and effective team elements.

Participants reported high satisfaction with the training, indicating its potential to enhance collaboration between patients and researchers in future cystic fibrosis research efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of a virtual patient-centered outcomes research training program for the cystic fibrosis community. Godfrey, EM., Thayer, EK., Mentch, L., et al.[2021]

A review of 209 lung cancer phase I and II trials presented at the American Society for Clinical Oncology meetings from 2017 to 2019 revealed significant variability in how adverse events (AEs) were reported, with six different thresholds for reporting AEs of any grade.

Treatment-related AEs were reported twice as often as treatment-emergent AEs, and there was a lack of clear definitions for critical terms like dose-limiting toxicity and serious AEs, highlighting the need for standardized reporting methods to improve data comparability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variation in Toxicity Reporting Methods for Early Phase Lung Cancer Treatment Trials at Oncology Conferences. Simons, EA., Smith, DE., Gao, D., et al.[2021]

A review of 175 oncology publications involving 96,125 patients revealed that the reporting of adverse events is often incomplete, with a median completeness score of only eight out of 14 possible elements based on CONSORT guidelines.

Most studies selectively reported adverse events, with 96% only including those above a certain severity threshold, and 88% grouping events of varying severity, highlighting the need for standardized reporting practices in oncology to improve clarity and consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in cancer clinical trial publications. Sivendran, S., Latif, A., McBride, RB., et al.[2022]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

Among 156 clinical trials for new drugs, safety results were reported in ClinicalTrials.gov for 58.3% of trials and in peer-reviewed publications for 67.9%, indicating similar availability of safety data across both sources.

ClinicalTrials.gov provided more complete reporting for serious adverse events and adverse events compared to publications, suggesting it could be a valuable resource for monitoring drug safety post-approval.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of clinical trial safety results in ClinicalTrials.gov for FDA-approved drugs: A cross-sectional analysis. Chen, KY., Borglund, EM., Postema, EC., et al.[2022]

A survey of 509 clinical research associates (CRAs) and research nurses (RNs) revealed significant variability in adverse event (AE) reporting practices, with only 51.2% using standardized methods, highlighting a need for improved training and consistency.

Respondents identified major challenges in AE reporting, such as differences in trial protocols and definitions, and expressed strong support for additional resources like online reporting modules and standardized tracking forms to enhance reporting accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges and Barriers to Adverse Event Reporting in Clinical Trials: A Children's Oncology Group Report. Miller, TP., Marx, MZ., Henchen, C., et al.[2023]

The National Cancer Institute's booklet 'What Are Clinical Trials All About?' was developed to help cancer patients understand clinical trials, which are essential for improving cancer treatments, and has been used internationally as a model for patient education.

In a study involving 203 patients who received the booklet and 194 control patients, the effectiveness of the booklet was evaluated, indicating that it may enhance patients' attitudes, knowledge, and beliefs about clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the National Cancer Institute's clinical trials booklet. Davis, SW., Nealon, EO., Stone, JC.[2007]

An educational video significantly improved lung cancer patients' self-assessed likelihood to enroll in clinical trials, indicating that better knowledge can positively influence attitudes towards participation.

While the video group showed higher enrollment rates in clinical trials (25.4% for both therapeutic and nontherapeutic trials combined) compared to the standard care group (15.9%), these differences were not statistically significant, suggesting the need for larger studies to confirm the impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An educational video to increase clinical trials enrollment among lung cancer patients. Du, W., Mood, D., Gadgeel, S., et al.[2022]

A randomized controlled trial with 63 oncology patients tested a video educational program aimed at increasing clinical trial knowledge and participation, but the results showed no significant difference in enrollment between the video intervention group and the control group after one year.

Minority participants expressed more negative beliefs and barriers to participation in clinical trials compared to white participants, highlighting the need for tailored messaging to address these concerns and improve enrollment in underrepresented communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of an Educational Video on Clinical Trial Enrollment and Knowledge in Ethnic Minorities: A Randomized Control Trial. Skinner, JS., Fair, AM., Holman, AS., et al.[2020]

A study involving 36 Hispanic cancer patients and caregivers revealed low awareness and understanding of clinical trials, highlighting the need for targeted educational interventions.

In response, a Spanish-language DVD and booklet were developed based on focus group feedback, which is now being tested in a randomized control trial to improve knowledge and participation in clinical trials among Hispanic populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving awareness of cancer clinical trials among Hispanic patients and families: audience segmentation decisions for a media intervention. Quinn, GP., McIntyre, J., Gonzalez, LE., et al.[2021]

Educational animations significantly improved cancer patients' understanding and attitudes towards clinical trials compared to traditional brochures, especially benefiting those with lower motivation and comprehension skills.

The study involved 1194 cancer patients and survivors and demonstrated that animations are more effective than NIH materials in conveying complex information about clinical trials, such as placebos and randomization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Animations about Clinical Trial Participation for Cancer Patients and Survivors. Occa, A., Morgan, SE.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Moving from evaluation to value in cancer care. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Integrating Care Coordination and Mental Health Research Into Dialysis Practice: Stakeholder Perspectives, Methods, and Outcomes. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A practice-based tool for engaging stakeholders in future research: a synthesis of current practices. [2016]

4. Netherlands pubmed.ncbi.nlm.nih.gov

[Patient or disease in oncology?] [2021]

5. England pubmed.ncbi.nlm.nih.gov

Development and evaluation of a virtual patient-centered outcomes research training program for the cystic fibrosis community. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Variation in Toxicity Reporting Methods for Early Phase Lung Cancer Treatment Trials at Oncology Conferences. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse event reporting in cancer clinical trial publications. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Reporting of clinical trial safety results in ClinicalTrials.gov for FDA-approved drugs: A cross-sectional analysis. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Challenges and Barriers to Adverse Event Reporting in Clinical Trials: A Children's Oncology Group Report. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the National Cancer Institute's clinical trials booklet. [2007]

12. United States pubmed.ncbi.nlm.nih.gov

An educational video to increase clinical trials enrollment among lung cancer patients. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

The Impact of an Educational Video on Clinical Trial Enrollment and Knowledge in Ethnic Minorities: A Randomized Control Trial. [2020]

14. United States pubmed.ncbi.nlm.nih.gov

Improving awareness of cancer clinical trials among Hispanic patients and families: audience segmentation decisions for a media intervention. [2021]

15. United States pubmed.ncbi.nlm.nih.gov

Animations about Clinical Trial Participation for Cancer Patients and Survivors. [2020]