Awareness Interventions for Research Participation

(AWEI Trial)

No longer recruiting at 1 trial location

Overseen By Catherine E Womack, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Tennessee

Disqualifiers: Non-AA, Under 50, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if educating African American cancer survivors about the importance of research can encourage more participation in studies. Participants will receive either a phone call from a specialist, a brochure, or no additional information to identify the most effective approach. These methods are called Awareness Enhancing Interventions. The trial seeks African American cancer survivors who have been cancer-free for 1 to 5 years, particularly those who have had cancers linked to obesity or physical activity. Participants must live in an area with wireless coverage and belong to the AMPLIFI recruitment pool. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance outreach and education for future cancer survivors.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these awareness interventions are safe?

Research shows that activities like distributing informational brochures and making phone calls from research experts are generally safe. These activities aim to help cancer survivors understand and feel positive about joining research studies. Since they involve only information sharing, not drugs or medical procedures, they carry minimal risk.

Past studies on similar activities, such as using digital tools to improve health, have shown no major negative effects. These methods to raise awareness are well-tolerated by participants. Based on current research, joining a trial that includes these activities is considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to boost research participation through innovative awareness techniques. Unlike traditional methods that might solely rely on written communication, this trial explores the impact of personalized interventions, like phone calls from research specialists or tailored brochures, on enhancing awareness among cancer survivors. These strategies not only aim to inform but also personalize the importance of research participation, potentially increasing engagement and recruitment in clinical studies. By focusing on direct communication and personalized education, the trial hopes to uncover more effective ways to encourage participation, which is crucial for advancing cancer research.

What evidence suggests that this trial's awareness enhancing interventions could be effective for increasing participation in cancer clinical research among African American cancer survivors?

Research has shown that educational efforts can improve understanding of cancer research. For instance, a study in Malawi found that people gained knowledge about cancer after watching an educational video. Another review found that education helps individuals with intellectual disabilities understand cancer better. Studies also indicate that increased awareness can lead to earlier cancer detection, resulting in better health outcomes. In this trial, participants will be randomized into different groups to test awareness-enhancing interventions. One group will receive a phone call from a Research Specialist, while another will receive a brochure. These tools aim to raise awareness and may encourage more people to participate in cancer research by highlighting its importance. ^{3 6 7 8 9}

Who Is on the Research Team?

Michelle Y Marttin, PhD

Principal Investigator

University of Tennessee

Maria Pisu, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for African American adults over 50 who've had certain cancers with a high survival rate, like breast or prostate cancer. They should be 1-5 years post-diagnosis and live where there's wireless service. They must also be in the AMPLIFI recruitment pool.

Inclusion Criteria

Reside in an area with wireless coverage

In the AMPLIFI recruitment pool

I am a Black adult over 50 with certain types of cancer linked to obesity or low physical activity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Awareness-Enhancing Intervention

Participants receive the AWEI intervention over a two-week period to increase awareness and positive attitudes about research.

2 weeks

Intervention delivered virtually

Recruitment Call

Participants receive a recruitment call to discuss participation in the AMPLIFI study.

1 week

1 phone call

Follow-up

Participants are monitored for their interest in participating and returning the consent form.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Awareness Enhancing Interventions

Trial Overview

The study tests if different types of awareness interventions (like brochures and navigation aids) given by researchers or cancer survivors can boost participation in cancer research among African American survivors.

How Is the Trial Designed?

Group I: Navigation Experimental Treatment 4 Interventions

After receiving recruitment letter from AMPLIFI, participant randomized to this arm will receive a phone call from a Research Specialist who will discuss the importance of research participation for cancer survivors to increase research awareness and aid in recruitment. The information will focus on the importance of research and will be delivered from the perspective of either a researcher or a cancer survivor.

Group II: Brochure Experimental Treatment 4 Interventions

After receiving recruitment letter from AMPLIFI, participant randomized to this arm will receive a brochure which will focus on the importance of research participation for cancer survivors in order to increase research awareness and aid in recruitment.

Group III: Control Group Active Control 1 Intervention

This group will receive no intervention before receiving the AMPLIFI Recruitment Call

Who Is Running the Clinical Trial?

University of Tennessee

Lead Sponsor

Trials

202

Recruited

146,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Citations

1.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2829658

Understanding of Clinical Trials Among Patients With ...

This survey study evaluates the knowledge, perceptions, and motivations among patients with cancer and their relatives in Turkey regarding ...

2.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK585662/

Health Promotion Among Cancer Patients: Innovative ... - NCBI

The results showed that art therapy in the form of water-color painting improved their global quality of life and reduced depression through sharing and ...

3.

hrbopenresearch.org

hrbopenresearch.org/articles/8-2

Evaluating interventions to enhance public awareness of ...

Late diagnoses are often linked to poorer outcomes, highlighting the need for prevention, early detection, and effective treatment programs.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11648583/

A Review on Educational Intervention Approaches ...

In 2022, a study in Malawi on cancer patients revealed that there were improvements in the post-video-intervention assessments in areas where ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0891422224001999

A systematic review of educational interventions to ...

This review comprehensively analyzes educational interventions aimed at enhancing cancer awareness among individuals with intellectual disabilities (IDs).

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04683510

Awareness Enhancing Interventions (AWEI)

The purpose of this study is to determine if increasing awareness and, thus, enhancing positive attitudes about research, prior to recruitment attempts, ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12242455/

Evidence-based digital health interventions for breast ...

We conducted an umbrella review to summarize the evidence on digital health interventions aimed at improving health-related outcomes for BCS.

8.

bmccancer.biomedcentral.com

bmccancer.biomedcentral.com/articles/10.1186/s12885-022-10082-9

Disparities in awareness of and willingness to participate in ...

This study aimed to 1) assess disparities in the awareness of and willingness to participate in CCTs between African American and White cancer survivors.

9.

researchgate.net

researchgate.net/publication/396926943_Knowledge_of_Clinical_Trials_Among_US_Cancer_Survivors_A_cross-sectional_study_of_HINTS-SEER_data_Preprint

Knowledge of Clinical Trials Among US Cancer Survivors

The purpose of this paper is to assess how different sources of health information influence likelihood of meeting cancer prevention behavior ...