Impact of Phone Call About Financial Reimbursement Program on Access to Cancer Clinical Trials
NCT ID: NCT03943082
Last Updated: 2021-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
252 participants
INTERVENTIONAL
2019-04-08
2021-10-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Cohort A : Usual Care (FRP Only)
Patients or parents/legal guardians of patients receive FRP brochure at the time of iMPACT consent.
Cancer Educational Materials
Receive FRP brochure
Questionnaire
Ancillary studies
Cohort A: Usual Care + Intervention (FRP + Follow-up)
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.
Cancer Educational Materials
Receive FRP brochure
Follow-Up Care
Receive follow-up phone call
Questionnaire
Ancillary studies
Interventions
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Cancer Educational Materials
Receive FRP brochure
Follow-Up Care
Receive follow-up phone call
Questionnaire
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eligible patients to be randomized for the iMPACT study must:
1. Carry a diagnosis of cancer
2. Patient is considered potentially eligible for a cancer therapeutic clinical trial (TCT) and is being offered an opportunity to sign an informed consent document for the cancer TCT
* Eligible patients to receive FRP (these documents will be requested by Lazarex Foundation, however research coordinator at site can help patient collect documents):
1. Have a household income =\< 700% of the 2018 Health and Human Services (HHS) Poverty Guidelines
2. Willing to provide proof of household income. Acceptable proof of income documents are: first two pages of signed copy of income tax return, or if a return is not filed, a copy of the most recent pay stub, unemployment check, Supplemental Security Income (SSI), Social Security Disability (SSD), or public assistance benefit notification. If a patient is not employed, they must submit a signed letter stating their current financial situation
7 Years
ALL
No
Sponsors
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Lazarex Cancer Foundation
UNKNOWN
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Hala Borno, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Countries
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Other Identifiers
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NCI-2019-00171
Identifier Type: REGISTRY
Identifier Source: secondary_id
189819
Identifier Type: -
Identifier Source: org_study_id