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| Name | Class |
|---|---|
| American Society of Clinical Oncology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Assistance + Enhanced Assistance | Experimental | In the time period that patients are receiving radiotherapy, study participants will receive standard plus enhanced financial assistance for unmet essential needs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard assistance | Other | Standard assistance includes all community and institutional resources currently available for which the participant qualifies. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delay-free completion of radiotherapy | 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. | Through completion of radiotherapy (estimated to be 4 months) |
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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.
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:
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| Name | Affiliation | Role |
|---|---|---|
| Joanna Yang, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| Enhanced assistance | Other | Enhanced assistance includes gift cards and checks to support food, housing, utilities, transportation, pharmacy, and other non-medical costs |
|
| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| D001932 | Brain Neoplasms |
| D015179 | Colorectal Neoplasms |
| D004938 | Esophageal Neoplasms |
| D008223 | Lymphoma |
| D012468 | Salivary Gland Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D008113 | Liver Neoplasms |
| D010051 | Ovarian Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D011471 | Prostatic Neoplasms |
| D013274 | Stomach Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D001005 | Anus Neoplasms |
| D019337 | Hematologic Neoplasms |
| D001943 | Breast Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D008175 | Lung Neoplasms |
| D007680 | Kidney Neoplasms |
| D010412 | Penile Neoplasms |
| D012878 | Skin Neoplasms |
| D013736 | Testicular Neoplasms |
| D013964 | Thyroid Neoplasms |
| D014594 | Uterine Neoplasms |
| D014625 | Vaginal Neoplasms |
| D014846 | Vulvar Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004935 | Esophageal Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009062 | Mouth Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012466 | Salivary Gland Diseases |
| D008107 | Liver Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D010182 | Pancreatic Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D013272 | Stomach Diseases |
| D014571 | Urologic Neoplasms |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D012004 | Rectal Neoplasms |
| D001004 | Anus Diseases |
| D006402 | Hematologic Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007674 | Kidney Diseases |
| D010409 | Penile Diseases |
| D013733 | Testicular Diseases |
| D013959 | Thyroid Diseases |
| D014623 | Vaginal Diseases |
| D014845 | Vulvar Diseases |
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