Enhanced Assistance During Radiotherapy for Unmet Essential Needs (EARN)

The Washington University

Status: Completed

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

Treatments: Other: Standard assistance; Other: Enhanced assistance

Study type: Interventional

Funder types: Other

Identifiers

NCT06582849

202408150

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Standard Assistance + Enhanced Assistance

Experimental group

Description:

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

Treatment:

Other: Enhanced assistance

Other: Standard assistance