Clinical trial NCT06582849: Enhanced Assistance During Radiotherapy for Unmet Essential Needs
Official title: Enhanced Assistance During Radiotherapy for Unmet Essential Needs (EARN): a Single Center Hybrid Type 1 Efficacy-implementation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Keywords: Financial assistance
Health-related social needs
Social determinants of health
Radiotherapy
Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: American Society of Clinical Oncology
First posted: 2024-09-03
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Delay-free completion of radiotherapy
timeFrame: Through completion of radiotherapy (estimated to be 4 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Joanna Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: