Education Program for Cancer

Overseen By Aaron Roberts

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Hawaii

Disqualifiers: Previous cancer trial participation

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

Compensation: Varies

Number of Visits: 3

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called CTNow, designed to help people in rural areas learn about cancer clinical trials and how to access them. It includes educational materials for both patients and healthcare providers. Patients watch short videos on the basics of clinical trials, while providers participate in teleconference sessions to learn about trial opportunities in Hawaii. Individuals diagnosed with any type of cancer, receiving treatment, and living in Hawaii, Kauai, or Maui counties may be eligible to participate. As an unphased trial, this study offers a unique opportunity to enhance understanding of clinical trials and improve access to cancer treatment information.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this education program is safe?

Research has shown that educational programs like CTNow are generally safe for participants. Unlike medical treatments, these programs do not involve drugs or procedures that could cause physical harm. Instead, they focus on providing information and support.

In the CTNow Patient Education Program, participants watch short videos and use a tablet to learn about clinical trials. This type of program carries no risk of physical side effects.

The CTNow Provider Education Program is also low-risk. Providers participate in informational sessions through teleconferences. These sessions aim to increase knowledge and do not pose any safety risks to the providers.

Overall, the CTNow program focuses on learning and sharing information, which is considered very safe. Participants can feel comfortable knowing they are not exposed to physical risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's all about empowering both patients and providers with knowledge about cancer clinical trials. Unlike standard treatment options that focus solely on medical interventions, this trial introduces a multimedia educational program for patients and tailored informational sessions for providers. The patient education intervention breaks down complex topics into bite-sized, easy-to-understand modules that cover everything from the basics of clinical trials to myths and real-life stories. Meanwhile, the provider sessions offer personalized insights into clinical trial infrastructure and opportunities in Hawaii, ensuring that both patients and healthcare providers are better equipped to navigate the clinical trial landscape. This focus on education and awareness could lead to more informed decisions and greater participation in clinical trials.

What evidence suggests that this education program is effective for facilitating access to cancer clinical trials?

Research has shown that education programs for patients can improve their understanding of cancer clinical trials and reduce anxiety. One study found that these programs increase patient knowledge and help manage stress. In this trial, participants will receive a Patient Education Intervention, which includes a multimedia educational series providing comprehensive information on cancer clinical trials.

For healthcare providers, educational efforts have improved their understanding and attitudes towards clinical trials, making them more likely to discuss these trials with patients. In this trial, providers will participate in a Provider Education Intervention, consisting of informational sessions designed to enhance their knowledge and confidence regarding clinical trials. These findings suggest that educating both patients and providers can lead to better participation in cancer clinical trials. ^{6 7 8 9 10}

Who Is on the Research Team?

Izumi Okado, PhD

Principal Investigator

University of Hawaii Cancer Research Center

Are You a Good Fit for This Trial?

This trial is for cancer patients living in Hawaii, Kauai, or Maui counties. It's open to those who have been diagnosed with any type of cancer and are either currently receiving treatment, have already received treatment, or are expected to start treatment within the next 90 days.

Inclusion Criteria

I have been diagnosed with cancer.

Patients must be residents of Hawaii, Kauai, or Maui counties

I can read, write, and speak English.

Exclusion Criteria

Patients must not have previously participated in a cancer clinical trial. Those who have participated in a cancer clinical trial are not eligible for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Patient Education Intervention

Participants receive a multimedia educational series on cancer clinical trials

30 minutes

Self-paced, virtual

Provider Education Intervention

Providers receive informational sessions on clinical trial infrastructure and resources

3 sessions over 4-6 months

3 teleconference sessions

Follow-up

Participants are monitored for changes in awareness and knowledge of clinical trials

18 months

What Are the Treatments Tested in This Trial?

Interventions

• CTNow

Trial Overview CTNow aims to improve access and referrals to cancer clinical trials for rural residents through educational programs tailored for both patients and oncology providers, supplemented by teleconference support.

How Is the Trial Designed?

Group I: Provider Education Intervention Experimental Treatment 1 Intervention

The provider education intervention will consist of 3 provider informational sessions conducted individually. These individual provider sessions will be conducted by teleconference by the research team and scheduled according to provider's availability. Provider workshops are designed to provide both a background on clinical trial infrastructure in Hawaii and resources for additional information. The content of these sessions includes: * An overview of clinical trials infrastructure in Hawaii. * Available trials in Hawaii. At each informational session, the research team will review available trials and any new/upcoming trials with the provider. * An overview of how to get involved in clinical trials. As experience and background re: clinical trials may vary across providers, the content of these informational sessions will be tailored to each provider. Following the initial session, 2 additional meetings will be scheduled in 4-6 months as follow-up sessions.

Group II: Patient Education Intervention Experimental Treatment 1 Intervention

A multimedia educational series is designed to provide patient education on cancer clinical trials. The following topics are addressed: * What is a clinical trial? * Types of clinical trials. * Phases of clinical trials. * Benefits and drawbacks. * Costs. * FAQs. This section covers common myths and clarifies these myths using a Q\&A format. * How to join a clinical trial. Information about eligibility and informed consent. * Clinical trial stories. Testimonies from oncology providers and patients. Each module is approximately 2-5 minutes, and they can be reviewed in the order/schedule preferred by the patient. The overall program is 30 minutes to view including the videos. The tablet provided to patients provides additional benefits for participation.

Who Is Running the Clinical Trial?

University of Hawaii

Lead Sponsor

Trials

122

Recruited

55,200+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06237816

CTNow: A Clinical Trials Education Program for Rural ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7483356/

The impact of an online training program about cancer clinical ... A brief online course showed significant and sustained improvement in PCPs' general and local knowledge about cancer clinical trials.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1279770723012435

Article Effectiveness of Therapeutic Patient Education ... The results appear to be positive on anxiety, depression and psychological distress, patient knowledge and pain. However, data currently available on the ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06112002

Study Details | NCT06112002 | Evaluation of an Education ... This clinical trial evaluates a culturally tailored educational outreach intervention for increasing clinical trial knowledge, referral, and participation among ...

5. nature.com nature.com/articles/s41746-024-01387-z

Randomized clinical trial of a digital integrative medicine ... Our prior qualitative data suggest our intervention could help patients with cancer maintain healthy behaviors, reduce psychological distress, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03271099

Patient Navigation in Cancer Survivorship at a Safety Net ... Participants will be randomly assigned to receive usual care or to be followed by a Patient Navigator as part of their Survivorship Care Plan. Study ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5096459/

Patient participation in cancer clinical trials: A pilot test of ... The intervention was delivered by a trained lay navigator who viewed a 17-min CT educational video with each patient, assessed and answered their questions ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07223463

A Tailored Medication Adherence-Promotion Intervention ... A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved ...

9. cancer.gov cancer.gov/research/participate/clinical-trials

Cancer Clinical Trials Information - NCI Safety and Clinical Trials. Learn about informed consent, institutional review boards, and how trials are closely monitored to protect you.

10. uhcancercenter.org uhcancercenter.org/patients-families/clinical-trials/for-providers/cto-services

Clinical Trials Office Services Assist with the timely opening and implementation of clinical trials · Process and reporting of safety reports · Assist with protocol review and data safety ...