Impact of Phone Call About Financial Reimbursement Program on Access to Cancer Clinical Trials

University of California San Francisco (UCSF)

Status: Terminated

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Neoplasm

Treatments: Behavioral: Questionnaire; Other: Follow-Up Care; Behavioral: Cancer Educational Materials

Study type: Interventional

Funder types: Other

Identifiers

NCT03943082

189819

NCI-2019-00171 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 252 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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252 participants in 2 patient groups

Cohort A : Usual Care (FRP Only)

Active Comparator group

Description:

Patients or parents/legal guardians of patients receive FRP brochure at the time of iMPACT consent.

Treatment:

Behavioral: Questionnaire

Behavioral: Cancer Educational Materials

Cohort A: Usual Care + Intervention (FRP + Follow-up)

Experimental group

Description:

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.

Treatment:

Behavioral: Questionnaire

Behavioral: Cancer Educational Materials

Other: Follow-Up Care