Priming Survey for Cancer

(Prime GOC Trial)

Overseen By Lauren Reed-Guy, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Non-English speakers

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

Compensation: Varies

Number of Visits: 1

80 Participants Needed

Trial Summary

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 effectiveness of the Bidirectional Priming Intervention treatment for cancer?

The research highlights the importance of patient engagement and making informed decisions in cancer treatment, which can lead to better outcomes. This suggests that treatments like the Bidirectional Priming Intervention, which may involve patient engagement, could be effective in improving cancer care. ^{1 2 3 4 5}

How does the Priming Survey for Cancer treatment differ from other cancer treatments?

This treatment uses a 'prime and boost' strategy with dendritic cell vaccines to enhance the immune system's response against cancer. It is unique because it involves a personalized approach, using tumor-specific antigens to prime the immune system and then boosting it with synthetic vaccines, which is different from standard cancer treatments that do not typically use this method. ^{6 7 8 9 10}

What is the purpose of this trial?

This pilot study will evaluate whether an intervention aimed at hospitalized patients with advanced lung and gastrointestinal cancers can help facilitate goals-of-care (GOC) communication with their oncologists after discharge. While GOC communication is a recommended component of routine oncology care, many patients with solid cancers do not have the opportunity to talk with their oncologist about their goals and end-of-life preferences. Prior research has shown that a systematic method of prompting GOC communication with at-risk patients would address a key barrier to timely GOC communication and ensure that patients receive care that is in line with their personal preferences. This trial will enroll 80 participants, who will be randomized 1:1 to either an intervention or a control group. Participants in the intervention group will complete a short survey regarding their goals, preferences, and disease understanding. Survey responses will be shared with each participant's outpatient oncology team. Oncologists will subsequently receive a nudge in the electronic medical record reminding them of key survey responses and encouraging them to discuss them at the patient's first clinic visit after hospital discharge. The primary feasibility outcome is intervention completion rate and the primary clinical outcome is GOC documentation within 30 days of discharge in the intervention group compared to the control group.

Eligibility Criteria

This trial is for hospitalized patients with advanced lung and gastrointestinal cancers. It aims to help them communicate their end-of-life care preferences with oncologists after leaving the hospital. Participants must be willing to complete a survey and have their responses shared with their cancer care team.

Inclusion Criteria

Family member/caregiver of a patient meeting the above 4 criteria

Unplanned admission to the HUP Solid Oncology service

Anticipated discharge within the next 72h

Exclusion Criteria

I cannot complete a survey in English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention group complete a survey regarding their goals, preferences, and disease understanding. Survey responses are shared with the outpatient oncology team.

Up to 30 days

1 visit (in-person) for survey completion

Follow-up

Participants are monitored for goals-of-care documentation in the electronic medical record within 30 days of hospital discharge.

30 days

Treatment Details

Interventions

• Bidirectional Priming Intervention

Trial Overview The study tests if a 'priming' survey can improve discussions about goals of care between patients and doctors. Half the participants will take this survey, which prompts them to think about treatment goals, while the other half won't. Doctors get reminders in their records to talk about these topics during follow-up visits.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Participants in the intervention arm will complete a survey prior to hospital discharge. Their responses will be shared with each participant's outpatient oncology team.

Group II: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Conquer Cancer Foundation

Collaborator

Trials

22

Recruited

4,000+

Findings from Research

In a study of 577 cancer patients, breast cancer patients showed significantly higher rates of non-adherence to adjuvant chemotherapy guidelines compared to colon cancer patients, with rates of 69% for primary non-adherence and 89% for non-persistence at 6 months.

Patient-centered communication (PCCM) was found to be a critical factor influencing adherence, with lower communication scores linked to higher non-adherence, particularly among older patients and those diagnosed with breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy non-adherence, patient-centered communication, and patient-level factors in elderly breast and colon cancer patients. Mitchell, KR., Boyle, JR., Juricekova, L., et al.[2023]

References

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

Social and Clinical Correlates of Neoadjuvant Chemotherapy in Medicare Beneficiaries With Muscle Invasive Bladder Cancer From 2004-2015. [2022]

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

Closing Knowledge Gaps to Optimize Patient Outcomes and Advance Precision Medicine. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Does biomarker information impact breast cancer patients' preferences and physician recommendation for adjuvant chemotherapy? [2019]

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

Understanding how breast cancer patients use risk information from genomic tests. [2021]

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

Adjuvant chemotherapy non-adherence, patient-centered communication, and patient-level factors in elderly breast and colon cancer patients. [2023]

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

Antitumour dendritic cell vaccination in a priming and boosting approach. [2021]

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

Booster vaccinations against cancer are critical in prophylactic but detrimental in therapeutic settings. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effective tumor immunotherapy: start the engine, release the brakes, step on the gas pedal,...and get ready to face autoimmunity. [2017]

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

Minimal costimulatory requirements for T cell priming and TH1 differentiation: activation of naive human T lymphocytes by tumor cells armed with bifunctional antibody constructs. [2017]

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

Cell membrane-camouflaged liposomes and neopeptide-loaded liposomes with TLR agonist R848 provides a prime and boost strategy for efficient personalized cancer vaccine therapy. [2023]