Anal Cancer, Blood Cancer, Bone Cancer, Brain Cancer, Breast Cancer, Cervical Cancer, Colorectal Cancer, Esophagus Cancer, Head and Neck Cancer, Kidney Cancer, Liver Cancer, Lung Cancer, Lymphoma, Ovarian Cancer, Pancreatic Cancer, Penile Cancer, Prostate Cancer, Salivary Gland Cancer, Skin Cancer, Small Intestine Cancer, Stomach Cancer, Testicular Cancer, Thyroid Cancer, Urinary Bladder Cancer, Uterine Cancer, Vaginal Cancer, Vulvar Cancer
Conditions
Keywords
Financial assistance, Health-related social needs, Social determinants of health, Radiotherapy, Cancer
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.
Interventions
OTHEREnhanced assistance
Enhanced assistance includes gift cards and checks to support food, housing, utilities, transportation, pharmacy, and other non-medical costs
OTHERStandard assistance
Standard assistance includes all community and institutional resources currently available for which the participant qualifies.
Sponsors
American Society of Clinical Oncology
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed