Clinical trial NCT05034289: Promoting INformed Approaches in Precision Oncology and ImmuNoTherapy
Official title: Reducing Racial Disparities in Cancer Care With PINPOINT (Promoting INformed Approaches in Precision Oncology and ImmuNoTherapy)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Trials
Immunotherapy
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Pfizer
First posted: 2021-09-05
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 30 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 purpose: HEALTH_SERVICES_RESEARCH

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=30) for the pilot trial, the overall target sample size for the study is (n=78).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Community Advisory Board, Key Informants and Pilot Testers
timeFrame: June 2021-June 2022
measure: Website Development
timeFrame: June 2021-June 2023
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: The Rutgers Cancer Institute
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute
name: Anita Y Kinney, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: