Promoting INformed Approaches in Precision Oncology and ImmuNoTherapy

NCT ID: NCT05034289

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-12

Study Completion Date

2023-05-19

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Clinical Trials Immunotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PINPOINT Digital Educational Tool

Intervention Type 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).

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Anita Y. Kinney, PhD, RN

Study Principal Investigator; Associate Director for Cancer Health Equity

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anita Y Kinney, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute

Locations

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The Rutgers Cancer Institute

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Pro2021000072

Identifier Type: OTHER

Identifier Source: secondary_id

132101

Identifier Type: -

Identifier Source: org_study_id

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