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

Trial Summary

What is the purpose of this trial?

This trial will study different outreach methods to assess impact on enrollment of underrepresented minorities (specifically African Americans) to early phase cancer clinical treatment trials. Both patients and providers (those seeing enrolled patients) will be enrolled and receive the study interventions or no intervention (control arm).

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 data supports the effectiveness of the treatment Community Outreach, Digital Intervention, Glucophage, Fortamet, Glumetza, Riomet for cancer trial enrollment?

Research shows that digital interventions, like smartphone apps, can help patients stick to their cancer treatment plans by providing education and support, which may improve treatment outcomes. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The research articles provided do not contain specific safety data for the treatment under the names Community Outreach, Digital Intervention, Glucophage, Fortamet, Glumetza, or Riomet. Therefore, no relevant safety information is available from these sources. ^{2 6 7 8 9}

How does this treatment differ from other cancer treatments?

The treatment in this trial is unique because it focuses on improving patient adherence to endocrine hormonal therapy (EHT) for breast cancer through a personalized smartphone app and patient navigator support, which is not a standard approach in current cancer treatments. This method aims to enhance patient education, self-monitoring, and communication with healthcare providers, potentially improving survival rates and quality of life. ^{1 6 10 11 12}

Research Team

Walter Stadler, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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]

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]

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 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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Improving adherence to endocrine hormonal therapy among breast cancer patients: Study protocol for a randomized controlled trial. [2020]

2. England 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. [2018]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Development of a Smartphone Program to Support Adherence to Oral Chemotherapy in People with Cancer. [2022]

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

Real World Adherence to and Persistence With Oral Oncolytics in Multiple Myeloma: A Systematic Review and Meta-analysis. [2022]

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

Characteristics Associated with Participation in ENGAGED 2 - A Web-based Breast Cancer Risk Communication and Decision Support Trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Involving American Indians and medically underserved rural populations in cancer clinical trials. [2022]

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

Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions. [2020]

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

Socioeconomic Barriers to Randomized Clinical Trial Retention in Patients Treated With Adjuvant Radiation for Early-Stage Breast Cancer. [2023]

9. United States 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. [2023]

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

Statewide cancer clinical trial navigation service. [2022]

11. United States 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. [2022]

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

Responding to a significant recruitment challenge within three nationwide psychoeducational trials for cancer patients. [2023]