Enhanced Assistance During Radiotherapy for Unmet Essential Needs

NCT ID: NCT06582849

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-04

Study Completion Date

2025-08-08

Brief Summary

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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

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Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard 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.

Group Type EXPERIMENTAL

Standard assistance

Intervention Type OTHER

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

Enhanced assistance

Intervention Type OTHER

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

Interventions

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Standard assistance

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

Intervention Type OTHER

Enhanced assistance

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Society of Clinical Oncology

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joanna Yang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Related Links

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http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

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202408150

Identifier Type: -

Identifier Source: org_study_id

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