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

NCT03943082 | Terminated

• 2 other identifiers: 189819NCI-2019-00171
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 2

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.

Conditions

Malignant Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Proportion of patients who sign consent for cancer TCT as well as by cancer type and phase of clinical trial within each arm

  At day 30

Study Arms (2)

Cohort A : Usual Care (FRP Only)

ACTIVE COMPARATOR

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

Behavioral: Cancer Educational Materials; Behavioral: Questionnaire

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.

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

Interventions

Cancer Educational Materials BEHAVIORAL

Receive FRP brochure

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

Follow-Up Care OTHER

Receive follow-up phone call

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

Questionnaire BEHAVIORAL

Ancillary studies

Also known as: Questionnaires

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

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• COHORT A:
• Eligible patients to be randomized for the iMPACT study must:
• Carry a diagnosis of cancer
• 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):
• Have a household income =\< 700% of the 2018 Health and Human Services (HHS) Poverty Guidelines
• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Lazarex Cancer Foundation: collaborator

Study Sites (2)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms

Interventions

Aftercare; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Hala Borno, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: April 8, 2019
• Primary Completion: October 26, 2021
• Study Completion: October 26, 2021
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)