Guiding Participation Toward Understanding, Inclusion, Diversity, and Equity for Cancer Clinical Trials (GUIDE) Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Participant perceptions of the intervention (acceptability, appropriateness, feasibility)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Food insecurity, housing instability, transportation challenges, or financial instability documented in the Supportive Cancer Care Questionnaire in Epic Electronic Medical Record (EPIC), OR
- •Concerns about insurance, cost of trial, additional trial visits, travel, transportation, childcare/eldercare, OR unable to take time off work, etc., as documented by clinical trial pre-screening (CTPS) or provider, OR
- •Medicaid insurance (including Medicaid pending) documented in EPIC, OR
- •Respond affirmatively (yes, maybe, possibly, I think so, etc.) to the social needs screening question asked by our Research Coordinator: "During your cancer treatment, are you interested in assistance with transportation, food, housing, financial resources, or other barriers to treatment?"
- •Able to speak English
排除标准
- •Unable to speak English
- •Children, adolescents, and teens under the age of 18 years
- •Patients participating on clinical trials providing financial navigation, such as clinicaltrials.gov identifier (CT ID): NCT04960787
- •Patients refusing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization
研究组 & 干预措施
Arm II (SOC)
Patients receive SOC supportive care services.
干预措施: Best Practice (Other)
ARM I (Clinical trial navigator, SOC)
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.
干预措施: Best Practice (Other)
ARM I (Clinical trial navigator, SOC)
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.
干预措施: Patient Navigation (Behavioral)
结局指标
主要结局
Participant perceptions of the intervention (acceptability, appropriateness, feasibility)
时间窗: At 6 months
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.
Proportion of patients in each arm that enroll in a clinical trial
时间窗: 6 months post-baseline
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.
Proportion of patients in each arm retained to a clinical trial
时间窗: 6 months post-baseline
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.
Patient trust
时间窗: 6 months post-baseline
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).
Health related quality of life
时间窗: 6 months post-baseline
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.
Resilience
时间窗: 6 months post-baseline
Will be assessed using the Brief Connor-Davidson Resilience Scale to assess the ability to recover or bounce back from stress.
Resolution of health-related social needs
时间窗: 6 months post-baseline
Will be measured by comparing the responses to the Health Related Social Needs (HRSN) questions (food insecurity, housing instability, transportation challenges, financial distress).
Financial burden
时间窗: 6 months post-baseline
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.
Participant perceptions of the intervention (acceptability, appropriateness, feasibility)
时间窗: At 6 months
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.
次要结局
- Staff time and effort to deliver intervention(At 6 months)
- Participant time costs(At 6 months)
- Amount of money provided to participants for reimbursement of trial-related expenses(At 6 months)
- Staff time and effort to deliver intervention(At 6 months)
- Participant time costs(At 6 months)
- Overhead(At 6 months)
- Amount of money provided to participants for reimbursement of trial-related expenses(At 6 months)