Promoting INformed Approaches in Precision Oncology and ImmuNoTherapy

NCT05034289 | Completed Results

• 2 other identifiers: 132101Pro2021000072
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Clinical Trials; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Knowledge About Precision Oncology

  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

  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.

  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

  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

  Baseline assessed before exposure to the PINPOINT intervention; follow-up assessed by survey within approximately 1 week after the participant's oncology consultation.

Study Arms (1)

PINPOINT Digital Educational Tool

EXPERIMENTAL

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

Interventions

PINPOINT Digital Educational Tool BEHAVIORAL

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).

PINPOINT Digital Educational Tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• American Cancer Society, Inc.: collaborator
• Pfizer: collaborator

Study Sites (1)

The Rutgers Cancer Institute

New Brunswick, New Jersey, 08901, United States

Location

Results Point of Contact

• Title: Anita Y. Kinney, PhD
• Organization: Rutgers Cancer Institute

anita.kinney@rutgers.edu

(732) 865-3375

Study Officials

• Anita Y Kinney, PhD, RN

  Rutgers Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator; Associate Director for Cancer Health Equity

Model Details: A community-engaged approach, including a Community Advisory Board and two rounds of key informant interviews with Black patients with cancer, their relatives, and providers (n = 48) were used to develop and refine the multimedia digital intervention. Thematic analysis was conducted for qualitative data. The intervention was then pilot-tested with 33 Black patients with cancer to assess feasibility, acceptability, appropriateness, knowledge, decision self-efficacy, and patient empowerment; Wilcoxon matched-pairs signed-rank test was used to analyze quantitative data.

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 5, 2021
• Study Start: July 12, 2021
• Primary Completion: May 19, 2023
• Study Completion: May 19, 2023
• Last Updated: May 18, 2026
• Results First Posted: May 18, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)