Enhanced Assistance During Radiotherapy For Unmet Essential Needs

Study Overview

Enhanced Assistance During Radiotherapy for Unmet Essential Needs

This is a prospective single-arm study of an enhanced assistance intervention for patients with unmet essential needs undergoing >10 fractions of radiotherapy comparing delay-free completion of radiotherapy in study participants to historic controls.

N/A

Bone Cancer
Brain Cancer
Colorectal Cancer
Esophagus Cancer
Lymphoma
Salivary Gland Cancer
Head and Neck Cancer
Liver Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Small Intestine Cancer
Stomach Cancer
Urinary Bladder Cancer
Anal Cancer
Blood Cancer
Breast Cancer
Cervical Cancer
Lung Cancer
Kidney Cancer
Penile Cancer
Skin Cancer
Testicular Cancer
Thyroid Cancer
Uterine Cancer
Vaginal Cancer
Vulvar Cancer

OTHER: Standard assistance
OTHER: Enhanced assistance

202408150

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-08-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-25
First Submitted that Met QC Criteria 2024-08-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2025-08-26
First Posted (ESTIMATED) 2024-09-03	Results First Posted N/A	Last Verified 2025-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Standard Assistance + Enhanced Assistance In the time period that patients are receiving radiotherapy, study participants will receive standard plus enhanced financial assistance for unmet essential needs.	OTHER: Standard assistance Standard assistance includes all community and institutional resources currently available for which the participant qualifies. OTHER: Enhanced assistance Enhanced assistance includes gift cards and checks to support food, housing, utilities, transportation, pharmacy, and other non-medical costs

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Standard Assistance + Enhanced Assistance

In the time period that patients are receiving radiotherapy, study participants will receive standard plus enhanced financial assistance for unmet essential needs.

OTHER: Standard assistance

Standard assistance includes all community and institutional resources currently available for which the participant qualifies.

OTHER: Enhanced assistance

Enhanced assistance includes gift cards and checks to support food, housing, utilities, transportation, pharmacy, and other non-medical costs

Primary Outcome Measures	Measure Description	Time Frame
Delay-free completion of radiotherapy	Defined as: (1) completing all fractions of radiotherapy AND (2) delaying fewer than 5 fractions. Patients who do not initiate a recommended course of radiotherapy will be considered as not completing radiotherapy; however, in the rare case where the patient's radiotherapy treatment recommendation changes by their physician(s) to no longer include radiotherapy, such patients will be dropped from the study and excluded from analyses.	Through completion of radiotherapy (estimated to be 4 months)

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

At least 18 years of age.
Planned to receive or currently receiving a protracted course of curative-intent (neoadjuvant, definitive, or postoperative) radiotherapy.

For the purposes of this study, radiotherapy must consist of >10 fractions (if radiotherapy not yet initiated) or >15 additional fractions after the date of consent (if radiotherapy initiated prior to study consent).
Be willing to undergo radiotherapy at the Barnes-Jewish Hospital location.
Indicate at least 1 unmet essential need, including food insecurity, transportation insecurity, housing instability, utility needs, childcare needs, or other financial insecurity.
Accept a referral to and meet with a social worker.
Have unmet essential needs that will not be able to be fully addressed by standard assistance. This determination can be made by the assigned social worker or by the patient after they meet with the social worker.
Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Planned or scheduled to undergo radiotherapy simulation more than 28 days from the date of consent.
Admitted to the hospital and not expected to undergo >10 fractions of radiotherapy as an outpatient.
Undergoing treatment for anaplastic thyroid cancer. Patients with anaplastic thyroid cancer have a relatively low likelihood of completing radiotherapy due to the aggressive disease course.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

American Society of Clinical Oncology

Investigators

PRINCIPAL_INVESTIGATOR: Joanna Yang, M.D., Washington University School of Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record