Promoting INformed Approaches in Precision Oncology and ImmuNoTherapy (PINPOINT)

Reducing Racial Disparities in Cancer Care With PINPOINT (Promoting INformed Approaches in Precision Oncology and ImmuNoTherapy)

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. The sample size for the qualitative interviews was (n=48) when saturation was achieved. With a goal of (n=33) for the pilot trial, the overall target sample size for the study is (n=81).

Study Overview

• Status: Completed
• Conditions: Immunotherapy; Clinical Trials
• Intervention / Treatment: Behavioral: PINPOINT Digital Educational Tool

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • The Rutgers Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Study Population

Black/African American cancer patients, blood relatives or spouse of Black/African American cancer patients or health providers to Black/African American cancer patients

Description

Inclusion Criteria

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 informed consent
• Able to complete 1 survey and an in-depth interview

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 informed consent
• Able to complete 1 survey and an in-depth interview

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 informed consent
• Able to complete 1 survey and an in-depth interview

Pilot Tester:

• Age 18 and older
• Self-identify as Black/African American
• Able to read and speak English fluently
• Able to provide informed consent
• Newly diagnosed with solid tumor cancer (Stage I-IV)
• Have not yet consulted with an oncologist regarding treatment
• Able to complete 2 surveys and an in-depth interview

Exclusion Criteria

Key informants will be excluded from the study if they do not meet the inclusion criteria. Pilot testers will be excluded from the study if they previously participated as key informants and do not meet inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PINPOINT Digital Educational Tool; Newly diagnosed Black cancer patients will be asked to access and engage with the educational website/intervention prototype before their clinic visit or in the clinic immediately before their appointment with their treating oncologist.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention	Measured using the 4-item Acceptability of Intervention Measure (AIM). Scores range from 1 to 5, with higher scores indicating greater acceptability. Cronbach's α = .85.	Immediately following completion of the PINPOINT intervention during the pilot testing session (same day; intervention and exit survey completed within approximately 30-40 minutes total).
Appropriateness of Intervention	Measured using the 4-item Intervention Appropriateness Measure (IAM). Scores range from 1 to 5, with higher scores indicating greater appropriateness. Cronbach's α = .91.	Immediately following completion of the PINPOINT intervention during the pilot testing session (same day; intervention and exit survey completed within approximately 30-40 minutes total).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge About Precision Oncology	Assessed using two researcher-developed items based on the intervention content. Scores ranged from 0 to 2, with higher scores indicating greater knowledge.	Baseline assessed before exposure to the PINPOINT intervention; follow-up assessed by survey within approximately 1 week after the participant's oncology consultation.
Knowledge About Clinical Trials	Assessed using 4 researcher-developed items based on the intervention content. Scores ranged from 0 to 4, with higher scores indicating greater knowledge.	Baseline assessed before exposure to the PINPOINT intervention; follow-up assessed by survey within approximately 1 week after the participant's oncology consultation.
Decision Self-efficacy for Tumor Genomic Sequencing.	Assessed using the 11-item Decision Self-Efficacy Scale. Scores ranged from 0 to 100, with higher scores indicating greater confidence in participants' ability to make informed decisions about tumor genomic sequencing.	Baseline assessed before exposure to the PINPOINT intervention; follow-up assessed by survey within approximately 1 week after the participant's oncology consultation.
Decision Self-efficacy for Targeted/Immune Therapy	Assessed using the 11-item Decision Self Efficacy Scale. Scored ranged from 0 to 100, with higher scored indicating greater confidence in participants' ability to make informed decisions about receiving targeted or immune therapies.	Baseline assessed before exposure to the PINPOINT intervention; follow-up assessed by survey within approximately 1 week after the participant's oncology consultation.
Patient Empowerment	Assessed using the 13-item Patient Activation Measure (PAM). Scores ranged from 0 to 100, with higher scores indicating greater levels of patient activation and empowerment in managing one's health and health care.	Baseline assessed before exposure to the PINPOINT intervention; follow-up assessed by survey within approximately 1 week after the participant's oncology consultation.

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Pfizer; American Cancer Society, Inc.
• Investigators: Principal Investigator: Anita Y Kinney, PhD, RN, Rutgers Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2021
• Primary Completion (Actual): May 19, 2023
• Study Completion (Actual): May 19, 2023

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 132101; Pro2021000072 (Other Identifier: Rutgers, The State University of New Jersey)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No