Enhanced Assistance During Radiotherapy for Unmet Essential Needs

Not Applicable

Recruiting

• Conditions: Bone Cancer; Brain Cancer; Colorectal Cancer; Esophagus Cancer; Lymphoma; Salivary Gland Cancer; Head and Neck Cancer; Liver Cancer; Ovarian Cancer; Pancreatic Cancer
• Interventions: Other: Standard assistance; Other: Enhanced assistance

• Registration Number: NCT06582849
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-30
• Study First Submitted QC: 2024-08-30
• Study First Posted: 2024-09-03
• Status Verified: 2024-10
• Study Start: 2024-10-04
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard Assistance + Enhanced Assistance	Standard assistance	In the time period that patients are receiving radiotherapy, study participants will receive standard plus enhanced financial assistance for unmet essential needs.
Standard Assistance + Enhanced Assistance	Enhanced assistance	In the time period that patients are receiving radiotherapy, study participants will receive standard plus enhanced financial assistance for unmet essential needs.

Primary Outcome Measures

Name	Time	Method
Delay-free completion of radiotherapy	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States