Clinical Trials, Immunotherapy
Conditions
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).
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.
Interventions
BEHAVIORALPINPOINT 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).
Sponsors
Rutgers, The State University of New Jersey
American Cancer Society, Inc.
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention | 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. |
| Appropriateness of Intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
| 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. | Assessed using 4 researcher-developed items based on the intervention content. Scores ranged from 0 to 4, with higher scores indicating greater knowledge. |
| 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. | Assessed using two researcher-developed items based on the intervention content. Scores ranged from 0 to 2, with higher scores indicating greater knowledge. |
| 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. | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnita Y Kinney, PhD, RN
Rutgers Cancer Institute
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 12 |
| Cancer Diagnosis Breast | 12 Participants |
| Cancer Diagnosis Other/multiple cancers | 10 Participants |
| Cancer Diagnosis Ovarian | 1 Participants |
| Cancer Diagnosis Prostate | 8 Participants |
| Cancer Stage Stage I | 11 Participants |
| Cancer Stage Stage II | 16 Participants |
| Cancer Stage Stage III | 8 Participants |
| Cancer Stage Stage IV | 2 Participants |
| Employment Status Employed | 31 Participants |
| Employment Status Missing | 1 Participants |
| Employment Status Other (e.g., student) | 6 Participants |
| Employment Status Unemployed | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Health Care System Distrust | 26.6 Score (rang 9-45) STANDARD_DEVIATION 5.1 |
| Health Literacy A little bit/not at all | 5 Participants |
| Health Literacy Extremely/quite a bit | 23 Participants |
| Health Literacy Somewhat | 5 Participants |
| Highest Education College graduate or higher | 13 Participants |
| Highest Education High school grad/GED | 15 Participants |
| Highest Education Less than high school | 1 Participants |
| Household Income <20,000 | 17 Participants |
| Household Income 20,001-50,000 | 11 Participants |
| Household Income >50,001 | 11 Participants |
| Household Income Missing | 1 Participants |
| Marital Status Married/civil union/living together | 16 Participants |
| Marital Status Separated/divorced/widowed | 7 Participants |
| Marital Status Single | 23 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 69 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex/Gender, Customized Female | 4 Participants |
| Sex/Gender, Customized Male | 9 Participants |
| Sex/Gender, Customized Transgender | 0 Participants |
| Specialty of Providers Nurse | 7 Participants |
| Specialty of Providers Physician | 4 Participants |
| Specialty of Providers Social Workers | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 15 | 0 / 13 | 0 / 33 |
| other Total, other adverse events | 0 / 20 | 0 / 15 | 0 / 13 | 0 / 33 |
| serious Total, serious adverse events | 0 / 20 | 0 / 15 | 0 / 13 | 0 / 33 |
Outcome results
None listed