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Completed

NCT Number: NCT05034289

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).

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Key information

Conditions

Clinical Trials Immunotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Rutgers Cancer Institute

New Brunswick, New Jersey, 08901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Acceptability of Intervention

    Time frame: 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).

    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.

  2. Appropriateness of Intervention

    Time frame: 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).

    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.

Secondary outcomes

  1. Knowledge About Precision Oncology

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

    Assessed using two researcher-developed items based on the intervention content. Scores ranged from 0 to 2, with higher scores indicating greater knowledge.

  2. Knowledge About Clinical Trials

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

    Assessed using 4 researcher-developed items based on the intervention content. Scores ranged from 0 to 4, with higher scores indicating greater knowledge.

  3. Decision Self-efficacy for Tumor Genomic Sequencing.

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

    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.

  4. Decision Self-efficacy for Targeted/Immune Therapy

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

    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.

  5. Patient Empowerment

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

    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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • American Cancer Society, Inc.
  • Pfizer

Registry information

Official study title

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

Acronym: PINPOINT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2021
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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