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NCT Number: NCT06582849

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.

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Key information

Conditions

Bone Cancer Adnexal Diseases Anal Cancer Anus Diseases Anus Neoplasms Blood Cancer Bone Diseases Bone Neoplasms Brain Cancer Brain Diseases Brain Neoplasms Breast Cancer Breast Diseases Breast Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cervical Cancer Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Esophagus Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Cancer Head and Neck Neoplasms Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Kidney Cancer Kidney Diseases Kidney Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Male Urogenital Diseases Mouth Diseases Mouth Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Penile Cancer Penile Diseases Penile Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Rectal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Salivary Gland Cancer Salivary Gland Diseases Salivary Gland Neoplasms Skin Cancer Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Small Intestine Cancer Stomach Cancer Stomach Diseases Stomach Neoplasms Stomatognathic Diseases Testicular Cancer Testicular Diseases Testicular Neoplasms Thoracic Neoplasms Thyroid Cancer Thyroid Diseases Thyroid Neoplasms Urinary Bladder Cancer Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cancer Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Cancer Vaginal Diseases Vaginal Neoplasms Vulvar Cancer Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard assistance

Other

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

Enhanced assistance

Other

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

Primary outcomes

  1. Delay-free completion of radiotherapy

    Time frame: Through completion of radiotherapy (estimated to be 4 months)

    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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • American Society of Clinical Oncology

Registry information

Official study title

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

Acronym: EARN

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 3, 2024
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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