Outreach Methods for Cancer Trial Enrollment

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Low GFR, High bilirubin, others

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

Compensation: Varies

Number of Visits: Unknown

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best ways to encourage African American patients to join early-phase cancer clinical trials. It tests methods such as sending digital messages (Digital Intervention) and involving community ambassadors to boost participation. The trial includes individuals who identify as African American, are visiting an oncology clinic, and may soon change their treatment. Participants and their doctors will receive various types of information and support to facilitate trial enrollment. As an unphased trial, this study explores innovative strategies to increase participation, offering a unique opportunity to contribute to meaningful research.

Will I have to stop taking my current medications?

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

What prior data suggests that these outreach methods are safe for increasing trial enrollment?

A previous study did not find specific safety information for the digital intervention or its combination with community outreach. Thus, no clear evidence exists on how well people handle these treatments based on past research.

However, these treatments emphasize communication and education, not medication or medical procedures. Digital interventions typically involve sending messages or sharing information online, which generally does not pose a direct risk to physical health. Similarly, community outreach involves conversation and support, which is also generally safe.

Since this trial does not test a new drug or medical procedure, the main goal is to assess how effectively these methods reach and engage people, rather than focusing on physical safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative methods to boost cancer trial enrollment. Traditional methods often rely on healthcare providers to inform patients about clinical trials, which can limit patient engagement. This trial introduces digital interventions, like emails and texts, providing patients with easy access to educational information about trials. Additionally, by incorporating community outreach, patients can connect with Community Ambassadors for personalized guidance and support. These new approaches aim to make trial information more accessible and engaging, potentially increasing participation and diversity in cancer research.

What evidence suggests that this trial's outreach methods could be effective for increasing enrollment of underrepresented minorities in cancer trials?

Research has shown that digital tools can improve healthcare for cancer patients. For instance, a digital health program has helped breast cancer patients feel better. These tools also provide cancer survivors with more social support.

In this trial, participants in the Digital Intervention arm will receive digital messages containing educational information about clinical trials. Meanwhile, the Digital Intervention + Community Outreach arm combines digital methods with community outreach, inviting participants to contact a Community Ambassador for further support. Past studies have demonstrated that combining community outreach with digital methods greatly reduces disparities in cancer care. These combined efforts aim to encourage more people to join clinical trials by making information and access easier. ^{3 6 7 8 9}

Who Is on the Research Team?

Walter Stadler, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for African American adults who are scheduled for new or follow-up oncology appointments at the study site. It includes those with a recent biopsy or imaging, prostate cancer patients with rising PSA levels, and others identified by researchers as likely needing treatment changes.

Inclusion Criteria

I have an oncology appointment and a biopsy or scan scheduled within 2 weeks before seeing my doctor.

The doctor at the study site is available to see patients who meet the criteria mentioned earlier.

My PSA levels have been rising over the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive digital messages and/or community outreach to assess impact on enrollment

8 weeks

Ongoing digital communication

Follow-up

Participants are monitored for enrollment outcomes and feedback is collected

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Community Outreach
• Digital Intervention

Trial Overview The study is testing whether digital interventions and community outreach can increase enrollment of underrepresented minorities in early phase cancer clinical trials. Participants will either receive these novel outreach methods or no intervention.

How Is the Trial Designed?

Group I: Arm 3 (Digital Intervention + Community Outreach) Experimental Treatment 2 Interventions

Patient participants in this arm will receive digital messages (email, text, etc.) which include general educational information about clinical trials and available resources. They will also be invited to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial. Provider participants will also receive digital messages with educational materials and will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys.

Group II: Arm 2 (Digital Intervention) Experimental Treatment 1 Intervention

Patient participants in this arm will receive digital messages (email, text, etc.) which include general educational information about clinical trials and available resources. Provider participants will also receive digital messages with educational materials and will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys.

Group III: Arm 1 (No Intervention) Active Control 1 Intervention

Patient participants in this arm will receive no intervention but will be approached by their providers for participation in treatment clinical trials as per the usual methods. Provider participants will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Stand Up To Cancer

Collaborator

Trials

53

Recruited

40,100+

Published Research Related to This Trial

In a study of 253 breast cancer patients, those from more socioeconomically disadvantaged backgrounds were significantly more likely to drop out of a clinical trial, with a dropout rate of 21.7% by 3 years and 36.7% by 5 years.

The analysis revealed that patients who dropped out had a higher area deprivation index (ADI), indicating greater socioeconomic disadvantage, and were more likely to require assistance for practical needs, highlighting the need for targeted interventions to improve trial retention among these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Socioeconomic Barriers to Randomized Clinical Trial Retention in Patients Treated With Adjuvant Radiation for Early-Stage Breast Cancer. Shi, JJ., Lei, X., Chen, YS., et al.[2023]

A survey of 17 young adult cancer patients revealed that while most understood their treatment, 24% did not receive guidance on what to do if they missed a dose, indicating a gap in medication education.

Common barriers to adherence included side effects (59%), forgetfulness (47%), and depressive symptoms (35%), highlighting the need for improved support systems and education involving family and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the need for improved strategies and medication-related education to increase adherence for oral anticancer medications in the young adult oncology population. Divakaruni, A., Saylor, E., Duffy, AP.[2018]

A study involving 14 clinicians revealed that motivations for reporting serious oncology-associated adverse drug reactions included scientific curiosity and public health concerns, but feedback from pharmaceutical manufacturers was predominantly negative.

The research highlights the need for improved pharmacovigilance mechanisms, such as big data and registries, to enhance the reporting and documentation of adverse drug events, addressing barriers like complacency and indifference among clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions. Bennett, CL., Schooley, B., Taylor, MA., et al.[2020]

In a review of 19 studies involving 27,129 patients with multiple myeloma, the overall adherence to oral oncolytic treatments (OOTs) was found to be 67.9%, indicating that a significant number of patients struggle to consistently take their medications as prescribed.

Factors such as increasing age, higher comorbidity, polypharmacy, and lack of social support were associated with lower adherence rates, highlighting the need for targeted interventions to improve treatment compliance and persistence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real World Adherence to and Persistence With Oral Oncolytics in Multiple Myeloma: A Systematic Review and Meta-analysis. Naser, AY., Ofori-Asenso, R., Awawdeh, SA., et al.[2022]

The clinical trial navigation service increased patient awareness of available cancer trials, but this did not translate into higher enrollment rates due to timing issues, as many patients learned about trials only after starting treatment, which often disqualified them.

The study highlighted the importance of physician involvement in discussing clinical trial options with patients early in their treatment process, as well as the need for more comprehensive and accurate trial listings in government databases to improve accessibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statewide cancer clinical trial navigation service. Moffitt, K., Brogan, F., Brown, C., et al.[2022]

In a study of 891 new cancer patients at a community cancer care center, only 9% were enrolled in clinical trials, primarily due to a lack of relevant protocols or restrictive inclusion criteria.

Despite low overall enrollment, the participation rate was about three times higher than national averages, and targeted patient navigation programs helped increase enrollment among American Indian patients to 10%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Involving American Indians and medically underserved rural populations in cancer clinical trials. Guadagnolo, BA., Petereit, DG., Helbig, P., et al.[2022]

Adjuvant endocrine hormonal therapy (EHT) is crucial for nearly all breast cancer patients with hormone receptor-positive tumors, significantly reducing recurrence rates and the risk of death, yet about 33% of patients do not adhere to their prescribed medication.

This study aims to improve adherence to EHT through a bilingual, culturally tailored smartphone app and support from a patient navigator, with the goal of enhancing patient education, self-management, and ultimately improving survival and quality of life for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving adherence to endocrine hormonal therapy among breast cancer patients: Study protocol for a randomized controlled trial. Chalela, P., Munoz, E., Inupakutika, D., et al.[2020]

A randomized controlled trial involving 1,554 underserved 2-1-1 callers in Texas showed that adding telephone navigation to cancer control referrals significantly increased the completion of necessary services, such as Pap tests and smoking cessation counseling.

The intervention led to a 38% higher likelihood of completing any needed service compared to those who only received a referral, demonstrating that personalized navigation can effectively enhance access to cancer control services among low-income populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a 2-1-1 Telephone Navigation Program to Increase Cancer Control Behaviors: Results From a Randomized Controlled Trial. Fernandez, ME., Savas, LS., Atkinson, JS., et al.[2022]

The Cancer Information Service (CIS), American Cancer Society (ACS), and the Dr. Susan Love Research Foundation's Army of Women (AOW) were the most effective outreach strategies, contributing to 89% of the 2,134 participants recruited for psychoeducational trials over 33 months.

While these cancer information programs are valuable for recruitment, they may not provide a representative sample of the broader cancer patient population, which could affect the generalizability of trial results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responding to a significant recruitment challenge within three nationwide psychoeducational trials for cancer patients. Stanton, AL., Morra, ME., Diefenbach, MA., et al.[2023]

A smartphone self-management program was developed to improve adherence to oral chemotherapy in cancer patients, addressing key issues like forgetfulness, side effects, and lack of knowledge about treatment.

The program includes features like medication reminders and tailored information delivery, primarily through simple text messages, based on feedback from end-users, which may enhance its effectiveness in supporting patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Smartphone Program to Support Adherence to Oral Chemotherapy in People with Cancer. Skrabal Ross, X., Gunn, KM., Patterson, P., et al.[2022]

In a study involving 75 adult cancer patients, daily text messages aimed at improving adherence to oral anticancer medications showed high acceptability, with 90% of participants satisfied with the intervention.

While the text message intervention led to improved adherence and perceived social support, the differences in symptom severity and interference between the experimental and control groups were not statistically significant, indicating the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proof of Concept of a Mobile Health Short Message Service Text Message Intervention That Promotes Adherence to Oral Anticancer Agent Medications: A Randomized Controlled Trial. Spoelstra, SL., Given, CW., Sikorskii, A., et al.[2023]

Out of 2,569 eligible women, only 995 (38.7%) participated in the trial, indicating a significant gap in engagement despite efforts to communicate risk using plain language materials.

Participation was influenced by education level, with women who had some college education or a college degree being more likely to participate, while race/ethnicity also played a role, highlighting the need for targeted outreach to ensure equitable representation in breast cancer prevention trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics Associated with Participation in ENGAGED 2 - A Web-based Breast Cancer Risk Communication and Decision Support Trial. Wernli, KJ., Bowles, EA., Knerr, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10524586/

a target trial emulation using electronic health records - PMC We emulated target trials of metformin therapy and cancer risk using population-based linked electronic health records from the UK (2009–2016).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03618472

Comparison of the Effectiveness Metformin for Deceasing ... The investigators tested the hypothesis that short-term presurgical metformin reduces cellular proliferation in endometrial cancer. However, no good quality of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9594974/

Efficacy of metformin therapy in patients with cancer To investigate whether metformin monotherapy or adjunctive therapy improves the prognosis in patients with any type of cancer compared to non-metformin users.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05925257

Study Details | NCT05925257 | Digital Health Intervention ... Design and Evaluation of the Effectiveness of a Digital Health Intervention to Improve Health Care and Outcomes for Cancer Patients. Conditions. Breast Cancer.

5. ascopubs.org ascopubs.org/doi/10.1200/CCI.17.00044

Telemedicine-Enabled Clinical Trial of Metformin in ... This interventional oncology clinical trial is the first to be conducted through telemedicine. Telemedicine-enabled trials are feasible and may overcome ...

6. withpower.com withpower.com/trial/phase-neoplasms-6-2023-2e29b

Outreach Methods for Cancer Trial Enrollment Is the treatment generally safe for humans? The research articles provided do not contain specific safety data for the treatment under the names Community ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05237960

Metformin for the Prevention of Oral Cancer in Patients ... This phase IIb trial tests whether metformin works in preventing oral cancer in patients with oral leukoplakia (white patches) or erythroplakia (red patches).

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10837926/

Cancer Precision-Prevention trial of Metformin in adults ... Data monitoring. An independent Data and Safety Monitoring committee will be formed for this trial. This committee will assess the trial data ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01101438

NCT01101438 | A Phase III Randomized Trial of Metformin ... This study is looking at whether Metformin, an agent that is commonly used to treat diabetes, can decrease or affect the ability of breast cancer cells to grow.