Enhanced Assistance During Radiotherapy for Unmet Essential Needs (EARN): a Single Center Hybrid Type 1 Efficacy-implementation Study

INTRODUCTION

  • Org Study ID: 202408150
  • Secondary ID: N/A
  • NCT ID: NCT06582849
  • Sponsor: Washington University School of Medicine

BRIEF SUMMARY

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.

  • Overall Status
    Recruiting
  • Start Date
    October 4, 2024
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • 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

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Joanna Yang, M.D.

Role: Principal Investigator

Affiliation: Washington University School of Medicine

Overall Contact

Name: Joanna Yang, M.D.

Phone: 314-362-9700

Email: jcyang@wustl.edu

LOCATION

Facility Status Contact
Facility: Washington University School of Medicine
Saint Louis, Missouri 63110
United States
Status: Recruiting Contact: Contact
Joanna Yang, M.D.
314-362-9700
jcyang@wustl.edu

Principal Investigator
Joanna Yang, M.D.

Sub-Investigator
Justin Barnes, M.D.

Sub-Investigator
Kimberly Johnson, MPH, Ph.D.