Enhanced Assistance During Radiotherapy for Unmet Essential Needs

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06582849
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Washington University School of Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Joanna Yang, M.D.
Principal Investigator Affiliation	Washington University School of Medicine
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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 Website:	View Trial Website

Arms & Interventions

Arms

Experimental: 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.

Interventions

Other: - Standard assistance

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

Other: - Enhanced assistance

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Site Contact

Joanna Yang, M.D.

[email protected]

314-362-9700

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