Clinical trial NCT03943082: Impact of Phone Call About Financial Reimbursement Program on Access to Cancer Clinical Trials
Official title: A Pilot Feasibility Study for Improving Patient Access to Cancer Clinical Trials (iMPACT): A Financial Reimbursement Program for Patients in Cancer Therapeutic Clinical Trials
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Malignant Neoplasm
Hematopoietic and Lymphoid Cell Neoplasm
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Lazarex Cancer Foundation
First posted: 2019-05-09
Enrollment: 252
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

COHORT A:

* 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

Primary outcomes:
measure: Proportion of patients who sign consent to improving Patient Access to Cancer Clinical Trials (iMPACT) study among patients who are offered enrollment
timeFrame: Up to 90 days after therapeutic clinical trial (TCT) participation
Secondary outcomes:
measure: Proportion of patients who sign consent for cancer TCT as well as by cancer type and phase of clinical trial within each arm
timeFrame: At day 30
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Hala Borno, MD
role: PRINCIPAL_INVESTIGATOR
References: