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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-04530 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Andy Hill Cancer Research Endowment (CARE) Fund | UNKNOWN |
| National Cancer Institute (NCI) | NIH |
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This clinical trial evaluates a clinical trial navigation intervention to help increase participation and diversity in cancer clinical trials. Cancer clinical trials are an important part of the development of treatments, and improved patient care and outcomes. Despite this, only a small number of cancer patients participate in clinical trials. There are many different items that contribute to low clinical trial participation, including health-related social needs (HRSN) and financial burden. Guiding participation toward understanding, inclusion, diversity, and equity for cancer clinical trials (GUIDE), is a program that uses a trained clinical trial navigator, or "Guide", to work with identified potential cancer clinical trial patients to help them recognize and remove HRSN and financial barriers preventing clinical trial participation. A clinical trial navigation intervention, like GUIDE, may help increase participation and diversity in cancer clinical trials.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients meet with a clinical trial navigator to understand activities involved with clinical trials, identify financial barriers to clinical trial participation, and review available financial resources. Patients receive ongoing access to the Guide for up to 6 months. Patients also receive standard of care (SOC) supportive care services.
ARM II: Patients receive SOC supportive care services.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM I (Clinical trial navigator, SOC) | Experimental | Patients meet with a clinical trial navigator to understand activities involved with clinical trials, identify financial barriers to clinical trial participation, and review available financial resources. Patients receive ongoing access to the Guide via a check in meeting once monthly for up to 6 months. Patients also receive SOC supportive care services. |
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| Arm II (SOC) | Active Comparator | Patients receive SOC supportive care services. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive SOC supportive care services |
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| Measure | Description | Time Frame |
|---|---|---|
| Participant perceptions of the intervention (acceptability, appropriateness, feasibility) | Acceptability, appropriateness, and feasibility of the intervention will be assessed as potential themes in the qualitative interviews with patients in the GUIDE intervention arm of the trial. | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Staff time and effort to deliver intervention | This is the time spent by the Guide with patients, preparing for patient visits, and delivering the intervention. | At 6 months |
| Participant time costs |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients in each arm that enroll in a clinical trial | Will use descriptive statistics to characterize and compare by pilot trial arm all patients enrolled versus not enrolled in clinical trials. Will be comparing X% of individuals enrolled in a cancer clinical trial (x/50) in the intervention arm and Y% of individuals enrolled in a cancer clinical trial (y/50) in the usual care arm. Information about trial enrollment and retention at 6 months will be abstracted from Online Collaborative Research Environment (OnCore) Clinical Management System. |
Inclusion Criteria:
Patients ≥ 18 years of age
Identified as potentially eligible for an open clinical trial by clinical trial pre-screening
Have ≥ 1 health related social need, defined by
Able to speak English
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Mendoza, MD, MPH | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 14, 2025 | Jul 16, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Patient Navigation | Behavioral | Receive clinical trial navigator guide services |
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This is the time spent by patients on all activities related to the cancer clinical trial and with the Guide.
| At 6 months |
| Overhead | Overhead costs are defined as the indirect expenses associated with delivering the GUIDE intervention. This includes the facility costs, measured using the facilities and administration rate, as well as non-clinical equipment and supplies needed to deliver the intervention. Observation-based costs accrued over the intervention delivery period will be averaged and standardized to US 2024 dollars. | At 6 months |
| Amount of money provided to participants for reimbursement of trial-related expenses | The amount of money provided to participants for reimbursement of trial-related expenses. | At 6 months |
| 6 months post-baseline |
| Proportion of patients in each arm retained to a clinical trial | Will use descriptive statistics to characterize and compare by pilot trial arm all patients retained versus not retained in clinical trials. Assessment of trial retention will be restricted to the denominator of patients who enroll in a cancer clinical trial. Information about trial enrollment and retention at 6 months will be abstracted from OnCore Clinical Management System. | 6 months post-baseline |
| Patient trust | Will be measured by the 12-item Trust in Medical Researchers scale. Each item will be answered on a 5-point Likert scale and scored accordingly (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree). | 6 months post-baseline |
| Health related quality of life | Will be measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Score. The PROMIS Global Health instruments generate scores that are converted to T-scores, with a mean of 50 and a standard deviation of 10 in the US general population, allowing for comparison to a reference group. Higher T-scores indicate better health outcomes. | 6 months post-baseline |
| Resilience | Will be assessed using the Brief Connor-Davidson Resilience Scale to assess the ability to recover or bounce back from stress. | 6 months post-baseline |
| Resolution of health-related social needs | Will be measured by comparing the responses to the Health Related Social Needs (HRSN) questions (food insecurity, housing instability, transportation challenges, financial distress). | 6 months post-baseline |
| Financial burden | Will be measured from the patient perspective using the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for financial Toxicity (FACIT-COST) scale. FACIT-COST Includes 12 items with responses on a 5-point Likert type scale. The maximum and minimum total scores range from 0-44 with higher scores representing better financial wellbeing. | 6 months post-baseline |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |