Enhanced support for cancer patients during radiotherapy
Enhanced Assistance During Radiotherapy for Unmet Essential Needs (EARN): a Single Center Hybrid Type 1 Efficacy-implementation Study
NA · Washington University School of Medicine · NCT06582849
This study is testing whether extra support for cancer patients during their radiation treatment can help them finish their therapy on time by addressing important needs like food, transportation, and housing.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine (other) |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT06582849 on ClinicalTrials.gov |
What this trial studies
This study evaluates an enhanced assistance intervention for cancer patients with unmet essential needs who are undergoing more than 10 fractions of radiotherapy. Participants will receive additional support beyond standard assistance to address issues such as food insecurity, transportation, and housing instability. The effectiveness of this intervention will be assessed by comparing the timely completion of radiotherapy among participants to historical control data. The study aims to improve patient outcomes by ensuring that essential needs are met during treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are receiving or scheduled to receive curative-intent radiotherapy and have at least one unmet essential need.
Not a fit: Patients who do not have any unmet essential needs or those who are not undergoing a protracted course of radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the completion rates of radiotherapy for cancer patients facing essential needs.
How similar studies have performed: While similar studies addressing social determinants of health in cancer care are emerging, this specific approach of enhanced assistance during radiotherapy is relatively novel.
Eligibility criteria
Show full 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.
Where this trial is running
Saint Louis, Missouri
- Washington University School of Medicine — Saint Louis, Missouri, United States (RECRUITING)
Study contacts
- Principal investigator: Joanna Yang, M.D. — Washington University School of Medicine
- Study coordinator: Joanna Yang, M.D.
- Email: jcyang@wustl.edu
- Phone: 314-362-9700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bone Cancer, Brain Cancer, Colorectal Cancer, Esophagus Cancer, Lymphoma, Salivary Gland Cancer, Head and Neck Cancer, Liver Cancer