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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-00171 | Registry Identifier | NCI Clinical Trials Reporting Program |
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Accrual for Feasibility Met
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| Name | Class |
|---|---|
| Lazarex Cancer Foundation | UNKNOWN |
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This trial studies how well a follow-up phone call regarding financial reimbursement program (FRP) works in improving cancer patients' access to therapeutic cancer clinical trials. Follow-up phone call intervention regarding FRP may improve recruitment of cancer patients to cancer therapeutic clinical trials.
There are limited financial models that address the economic hardship associated with clinical research participation and how it might restrict clinical research access. The Lazarex Foundation offers a financial reimbursement program (FRP) to help patients and caregivers cover the out-of-pocket costs associated with clinical trial participation for almost ten years.
iMPACT is a pilot study to assess the overall feasibility of conducting a multi-center trial of the Lazarex sliding scale FRP among sociodemographically diverse patients of all cancer types enrolling/potentially enrolling in therapeutic clinical trials (TCTs). The study will formalize informing patients or parents/legal guardians of patients about the Lazarex sliding-scale FRP in order to evaluate whether operationalizing intensive follow-up about the Lazarex FRP improves recruitment to cancer TCTs.
All patients or parents/legal guardians of patients will be offered information about the FRP at initial time of TCT discussion/consent for the iMPACT study, however, participants will be randomized 1:1 to receive an additional follow-up call about the FRP or no follow-up call (usual care). Participants who are randomized to usual care will be provided a phone number for the Lazarex Foundation that they or their parent or legal guardian may contact directly. Therefore all patients or parents/legal guardians of patients in the study have access to FRP eligibility assessment through the Lazarex Foundation.
Participants or parents/legal guardians of participants will be surveyed at baseline (time of consent to iMPACT) and interviewed 30 days after consent to iMPACT. If a participant enrolls in a therapeutic clinical trial, he/she will also be given an additional survey after TCT participation and interviewed up to 90 days after TCT participation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A : Usual Care (FRP Only) | Active Comparator | Patients or parents/legal guardians of patients receive FRP brochure at the time of iMPACT consent. |
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| Cohort A: Usual Care + Intervention (FRP + Follow-up) | Experimental | Patients or parents/legal guardians of patients receive FRP brochure at the time of iMPACT consent and a follow-up phone call on day 3 after iMPACT consent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cancer Educational Materials | Behavioral | Receive FRP brochure |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who sign consent to improving Patient Access to Cancer Clinical Trials (iMPACT) study among patients who are offered enrollment | The point estimate and 95% confidence interval (CI) of the proportion will be obtained within each site, furthermore, by cancer type and by phase of the clinical trial within each site. | Up to 90 days after therapeutic clinical trial (TCT) participation |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who sign consent for cancer TCT as well as by cancer type and phase of clinical trial within each arm | Two-sample proportion test between two arms will be used between two arms within each site. The point estimate and 95% confidence interval (CI) of the proportion will be obtained within each site by cancer type and by phase of the clinical trial. | At day 30 |
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Inclusion Criteria:
COHORT A:
Eligible patients to be randomized for the iMPACT study must:
Eligible patients to receive FRP (these documents will be requested by Lazarex Foundation, however research coordinator at site can help patient collect documents):
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| Name | Affiliation | Role |
|---|---|---|
| Hala Borno, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States | ||
| University of California, San Francisco |
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| Follow-Up Care | Other | Receive follow-up phone call |
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| Questionnaire | Behavioral | Ancillary studies |
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|
| San Francisco |
| California |
| 94143 |
| United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000359 | Aftercare |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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