Enhanced Assistance During Radiotherapy for Unmet Essential Needs

Trial Title: Enhanced Assistance During Radiotherapy for Unmet Essential Needs

NCT ID: NCT06582849

Condition: 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

Conditions: Official terms:
Urinary Bladder Neoplasms
Salivary Gland Neoplasms
Anus Neoplasms
Vulvar Neoplasms
Brain Neoplasms
Stomach Neoplasms
Vaginal Neoplasms
Uterine Neoplasms
Testicular Neoplasms
Esophageal Neoplasms
Hematologic Neoplasms
Intestinal Neoplasms
Penile Neoplasms
Bone Neoplasms

Conditions: Keywords:
Financial assistance
Health-related social needs
Social determinants of health
Radiotherapy
Cancer

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Standard assistance
Description: Standard assistance includes all community and institutional resources currently available for which the participant qualifies.
Arm group label: Standard Assistance + Enhanced Assistance

Intervention type: Other
Intervention name: Enhanced assistance
Description: Enhanced assistance includes gift cards and checks to support food, housing, utilities, transportation, pharmacy, and other non-medical costs
Arm group label: Standard Assistance + Enhanced Assistance

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Washington University School of Medicine

Address:
City: Saint Louis
Zip: 63110
Country: United States

Status: Recruiting

Contact:
Last name: Joanna Yang, M.D.

Phone: 314-362-9700
Email: jcyang@wustl.edu

Investigator:
Last name: Joanna Yang, M.D.
Email: Principal Investigator

Investigator:
Last name: Justin Barnes, M.D.
Email: Sub-Investigator

Investigator:
Last name: Kimberly Johnson, MPH, Ph.D.
Email: Sub-Investigator

Start date: October 4, 2024

Completion date: December 31, 2025

Lead sponsor:
Agency: Washington University School of Medicine
Agency class: Other

Collaborator:
Agency: American Society of Clinical Oncology
Agency class: Other

Source: Washington University School of Medicine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06582849
http://www.siteman.wustl.edu