COMPLETED

Enhanced Assistance During Radiotherapy for Unmet Essential Needs

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-04

Study Completion:2025-08-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06582849

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Joanna Yang, M.D.

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine

St Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

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

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

Study Start Date2024-10-04

Study Completion Date2025-08-08

Study Record Updates