mHealth Application for Increasing Engagement with Clinical Trials for Black Patients with Pancreatic Cancer, PROCLAIM Trial

PRIMARY OBJECTIVE:

I. To determine the clinical trial education and communication needs of Black people with pancreatic cancer and develop an mHealth application for clinical trial education and communication tailored to subject needs. (Part 1)

II. To determine whether use of the mHealth application increases Black pancreatic cancer subjects’ likelihood of discussing clinical trials with provider. (Part 2)

SECONDARY OBJECTIVE:

I. To determine the impact of implementing the mHealth application within the pancreatic cancer clinical workflow based on clinic staff perceptions.

EXPLORATORY OBJECTIVES:

I. To determine whether clinical trial knowledge, preparedness for decision-making, and confidence in decision-making is impacted by the use of the mHealth app.

II. To determine the quality and ease of clinical trial discussions, and whether subjects were offered a therapeutic trial.

III. To determine whether using the mHealth application increases participation in clinical trials amongst Black pancreatic cancer subjects.

OUTLINE: Patients in part 1 are assigned to arm A or B, patients in part 2 are randomized to arm C or D, and heath care providers are assigned to arm E.

PART 1:

ARM A: Patients complete an interview on study.

ARM B: Patients view the mHealth application and complete surveys on study.

PART 2:

ARM C: Patients receive access to the mHealth educational application and receive standard of care written educational materials regarding disease education and available resources on study.

ARM D: Patients receive standard of care written educational materials regarding disease education and available resources on study.

ARM E: Health care providers complete an interview on study.

After completion of intervention, patients in arms C and D are followed up at 1, 3 and 6 months.