Promoting INformed Approaches in Precision Oncology and ImmuNoTherapy

Immunotherapy Clinical Trial

— PINPOINT  

Official title:

Promoting INformed Approaches in Precision Oncology and ImmuNoTherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05034289
• Other study ID #: 132101
• Secondary ID: Pro2021000072
• Status: Completed
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: April 24, 2023

Study information

• Verified date: December 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the research is to: develop an educational website to empower Black and African American cancer patients to make informed decisions about personalized cancer treatment and clinical trials.

Description:

The website offers tools for discussing innovative treatments with their clinicians, finding clinical trials, and locating support groups. We are conducting key informant interviews, testing the website with pilot tester and asking volunteers from our Community Advisory Board to review our website prototype to further improve its design and features.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: April 24, 2023
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Patient Key Informant:

• Age 18 and older
• Self-identify as Black/African American
• Diagnosed with solid tumor
• Able to read and speak English fluently
• Able to provide electronic informed consent
• Able to complete 2 surveys and an in-depth interview

Inclusion Criteria for Relative Key Informant:

• Age 18 and older
• Spouse, blood relative, or caregiver of a cancer patient who identifies as Black/African American
• Able to read and speak English fluently
• Able to provide electronic informed consent
• Able to complete 2 surveys and an in-depth interview

Inclusion Criteria for Provider Key Informant:

• Age 18 and older
• Physician, nurse, social worker, patient navigator, or financial counselor
• Work in oncology setting
• Able to read and speak English fluently
• Able to provide electronic informed consent
• Able to complete 1 survey and an in-depth interview

Related Conditions & MeSH terms

• Clinical Trials
• Immunotherapy

Intervention

Behavioral:
• PINPOINT Digital Educational Tool
The intervention prototype called the PINPOINT Digital Educational Tool will be comprised of four main sections that include information about: 1) precision oncology; 2) clinical trials; 3) "Learn More" screens; and 4) discussion points and questions for the treating clinician. The intervention prototype will also include a search function, short videos of patient testimonials, patient-provider interaction about immunotherapy and clinical trials, as well as a list of questions/concerns that the patient could print (or save electronically) and take with them to their provider visit. An optional chatbot will be available in the corner of the screen. Users can ask the chatbot questions about any of the material on the website or request additional information. The chatbot will also be able to help patients search for molecularly targeted and immunotherapy clinical trials and offer additional resources (such as websites and online support groups).

Locations

Country	Name	City	State
United States	The Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	American Cancer Society, Inc., Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Community Advisory Board, Key Informants and Pilot Testers	Employ a community-engaged approach, including a Community Advisory Board and key informant interviews, to a) assess knowledge, attitudes, beliefs, and sociocultural, clinical, and system-level factors (e.g., barriers) that may explain disparities in decisions about use of precision oncology in Black cancer patients	June 2021-June 2022
Primary	Website Development	Utilize this information to guide the iterative development and pilot testing of an innovative, patient-centered and culturally tailored internet-based education and decision support intervention, "Promoting INformed approaches in Precision Oncology and ImmuNoTherapy (PINPOINT)," to reduce racial disparities in access to and use of guideline-based therapy.	June 2021-June 2023