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| ID | Type | Description | Link |
|---|---|---|---|
| Pro2021000072 | Other Identifier | Rutgers, The State University of New Jersey |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
| Pfizer | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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). |
| 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. |
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Inclusion Criteria
Patient Key Informant:
Relative Key Informant:
Provider Key Informant:
Pilot Tester:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Anita Y Kinney, PhD, RN | Rutgers Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Rutgers Cancer Institute | New Brunswick | New Jersey | 08901 | United States |
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A total of 81 participants were enrolled across two phases of the study. In the Key Informant Interview Phase, 48 participants enrolled and completed their interviews. In the Pilot Intervention Phase, 33 participants enrolled. Of these, 30 were analyzed.
Participants were recruited between June 2021 and April 2022 through electronic medical record screening at the Rutgers Cancer Institute, University Hospital-Newark, and affiliated RWJBarnabas Health oncology sites. Additional recruitment occurred through Community Advisory Board (CAB) networks and community-based outreach.
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| ID | Title | Description |
|---|---|---|
| FG000 | Key Informant Patients | Black or African American adults with solid tumor cancers who completed a survey and an in-depth interview about experiences, knowledge, and attitudes related to precision oncology, immunotherapy, and clinical trials. |
| FG001 | Key Informant Relatives | Adult relatives, spouses, or caregivers of Black or African American cancer patients who completed a survey and an in-depth interview to share perspectives on cancer care, decision-making, and informational needs related to precision oncology and clinical trials. |
| FG002 | Key Informant Providers | Oncology health care professionals (including physicians, nurses, social workers, and patient navigators) who participated in an in-depth interview about barriers, facilitators, and cultural considerations impacting precision oncology and clinical trial participation among Black patients. |
| FG003 | PINPOINT Digital Education Tool (Pilot Test) | Newly diagnosed Black or African American adults with solid tumor cancers who used the PINPOINT digital education tool, a culturally tailored website providing information on precision oncology, clinical trials, and immunotherapy. The tool included interactive features such as videos, a chatbot, and downloadable communication aids. Participants completed pre- and post-intervention surveys |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants who completed follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Key Informant Patients | Black or African American adults with solid tumor cancers who completed a survey and an in-depth interview about experiences, knowledge, and attitudes related to precision oncology, immunotherapy, and clinical trials. |
| BG001 | Key Informant Relatives |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who completed both baseline and post-intervention surveys and remained eligible. | Posted | Mean | Standard Deviation | Score (1-5 scale) | 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). |
|
Time of enrollment to study completion, an average of 2 months
The study is of minimal risk to participants. Adverse events were self-reported through surveys and during communications with research personnel.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Key Informant Patients | Black or African American adults with solid tumor cancers who completed a survey and an in-depth interview about experiences, knowledge, and attitudes related to precision oncology, immunotherapy, and clinical trials. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anita Y. Kinney, PhD | Rutgers Cancer Institute | (732) 865-3375 | anita.kinney@rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 8, 2025 | Oct 9, 2025 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 8, 2025 | Oct 10, 2025 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 8, 2025 | Jan 20, 2026 | ICF_005.pdf |
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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.
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| 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. |
Adult relatives, spouses, or caregivers of Black or African American cancer patients who completed a survey and an in-depth interview to share perspectives on cancer care, decision-making, and informational needs related to precision oncology and clinical trials. |
| BG002 | Key Informant Providers | Oncology health care professionals (including physicians, nurses, social workers, and patient navigators) who participated in an in-depth interview about barriers, facilitators, and cultural considerations impacting precision oncology and clinical trial participation among Black patients. |
| BG003 | PINPOINT Digital Education Tool (Pilot Test) | Newly diagnosed Black or African American adults with solid tumor cancers who used the PINPOINT digital education tool, a culturally tailored website providing information on precision oncology, clinical trials, and immunotherapy. The tool included interactive features such as videos, a chatbot, and downloadable communication aids. Participants completed pre- and post-intervention surveys |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Household Income | Total income earned by all members of a household within a year. | Household Income data were not collected from Key Informant Providers. | Count of Participants | Participants |
|
| Highest Education | Participant highest completed level of education. | Count of Participants | Participants |
|
| Cancer Diagnosis | Specific location or organ in the body where participant cancer originates. | Cancer Diagnosis data were not collected from Key Informant Relatives or Key Informant Providers. | Count of Participants | Participants |
|
| Cancer Stage | Cancer stage was abstracted from the electronic medical record and reflects the clinically assigned stage at the time of diagnosis as documented by the treating oncology team, using standard staging practices appropriate to the participant's cancer type. Stage I indicates localized disease; Stage II indicates more advanced localized disease and/or limited regional spread; Stage III indicates locally advanced disease with regional lymph node involvement; and Stage IV indicates metastatic disease. | Cancer Stage data were not collected from Key Informant Relatives or Key Informant Providers. | Count of Participants | Participants |
|
| Marital Status | Participant current marital status at time of data collection. | Marital Status were not collected from Key Informant Providers. | Count of Participants | Participants |
|
| Employment Status | Current work situation of the participant. | Employment Status data were not collected from Key Informant Providers. | Count of Participants | Participants |
|
| Specialty of Providers | Type of professional training or role of the provider. | Specialty of Providers data were not collected from Key Informant Patients, Key Informant Relatives, or PINPOINT Digital Education Tool (Pilot Test). | Count of Participants | Participants |
|
| Health Care System Distrust | Health Care System Distrust was measured using a validated self-report scale assessing mistrust of the health care system. Scores range from 9 to 45, with higher scores indicating greater distrust of the health care system and lower scores indicating less distrust. | Household Income data were not collected from Key Informant Patients, Key Informant Relatives, or Key Informant Providers. | Mean | Standard Deviation | Score (rang 9-45) |
|
| Health Literacy | How confident are you in filling out medical forms by yourself? | Healthy Literacy data were not collected from Key Informant Patients, Key Informant Relatives, or Key Informant Providers. | Count of Participants | Participants |
|
|
|
| Primary | 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. | All participants who completed both baseline and post-intervention surveys and remained eligible. | Posted | Mean | Standard Deviation | Score (1-5 scale) | 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 | 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. | All participants who completed both baseline and post-intervention surveys and remained eligible. | Posted | Mean | Standard Deviation | Score (0-2) scale | Baseline assessed before exposure to the PINPOINT intervention; follow-up assessed by survey within approximately 1 week after the participant's oncology consultation. |
|
|
|
|
| Secondary | 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. | All participants who completed both baseline and post-intervention surveys and remained eligible. | Posted | Mean | Standard Deviation | Score (0-4) scale | Baseline assessed before exposure to the PINPOINT intervention; follow-up assessed by survey within approximately 1 week after the participant's oncology consultation. |
|
|
|
|
| Secondary | 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. | All participants who completed both baseline and post-intervention surveys and remained eligible. | Posted | Mean | Standard Deviation | Score (0-100 scale) | Baseline assessed before exposure to the PINPOINT intervention; follow-up assessed by survey within approximately 1 week after the participant's oncology consultation. |
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|
|
|
| Secondary | 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. | All participants who completed both baseline and post-intervention surveys and remained eligible. | Posted | Mean | Standard Deviation | Score (0-100) scale | Baseline assessed before exposure to the PINPOINT intervention; follow-up assessed by survey within approximately 1 week after the participant's oncology consultation. |
|
|
|
|
| Secondary | 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. | All participants who completed both baseline and post-intervention surveys and remained eligible. | Posted | Mean | Standard Deviation | Score (0-100) scale | Baseline assessed before exposure to the PINPOINT intervention; follow-up assessed by survey within approximately 1 week after the participant's oncology consultation. |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Key Informant Relatives | Adult relatives, spouses, or caregivers of Black or African American cancer patients who completed a survey and an in-depth interview to share perspectives on cancer care, decision-making, and informational needs related to precision oncology and clinical trials. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Key Informant Providers | Oncology health care professionals (including physicians, nurses, social workers, and patient navigators) who participated in an in-depth interview about barriers, facilitators, and cultural considerations impacting precision oncology and clinical trial participation among Black patients. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG003 | PINPOINT Digital Education Tool (Pilot Test) | Newly diagnosed Black or African American adults with solid tumor cancers who used the PINPOINT digital education tool, a culturally tailored website providing information on precision oncology, clinical trials, and immunotherapy. The tool included interactive features such as videos, a chatbot, and downloadable communication aids. Participants completed pre- and post-intervention surveys | 0 | 33 | 0 | 33 | 0 | 33 |
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|
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 20,001-50,000 |
|
| >50,001 |
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| Missing |
|
| High school grad/GED |
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| College graduate or higher |
|
| Ovarian |
|
| Other/multiple cancers |
|
| Stage III |
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| Stage IV |
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| Married/civil union/living together |
|
| Separated/divorced/widowed |
|
| Unemployed |
|
| Other (e.g., student) |
|
| Missing |
|
| Social Workers |
|
| A little bit/not at all |
|