NCT06582849

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

October 4, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2025

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

August 30, 2024

Last Update Submit

August 25, 2025

Conditions

Bone CancerBrain CancerColorectal CancerEsophagus CancerLymphomaSalivary Gland CancerHead and Neck CancerLiver CancerOvarian CancerPancreatic CancerProstate CancerSmall Intestine CancerStomach CancerUrinary Bladder CancerAnal CancerBlood CancerBreast CancerCervical CancerLung CancerKidney CancerPenile CancerSkin CancerTesticular CancerThyroid CancerUterine CancerVaginal CancerVulvar Cancer

Keywords

Financial assistanceHealth-related social needsSocial determinants of healthRadiotherapyCancer

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

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.

Other: Standard assistanceOther: Enhanced assistance

Interventions

Standard assistanceOTHER

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

Standard Assistance + Enhanced Assistance
Enhanced assistanceOTHER

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

Standard Assistance + Enhanced Assistance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

MeSH Terms

Conditions

Bone NeoplasmsBrain NeoplasmsColorectal NeoplasmsEsophageal NeoplasmsLymphomaSalivary Gland NeoplasmsHead and Neck NeoplasmsLiver NeoplasmsOvarian NeoplasmsPancreatic NeoplasmsProstatic NeoplasmsStomach NeoplasmsUrinary Bladder NeoplasmsAnus NeoplasmsHematologic NeoplasmsBreast NeoplasmsUterine Cervical NeoplasmsLung NeoplasmsKidney NeoplasmsPenile NeoplasmsSkin NeoplasmsTesticular NeoplasmsThyroid NeoplasmsUterine NeoplasmsVaginal NeoplasmsVulvar NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBone DiseasesMusculoskeletal DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEsophageal DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesLiver DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersPancreatic DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesStomach DiseasesUrologic NeoplasmsUrinary Bladder DiseasesUrologic DiseasesRectal NeoplasmsAnus DiseasesHematologic DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine Cervical DiseasesUterine DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesKidney DiseasesPenile DiseasesTesticular DiseasesThyroid DiseasesVaginal DiseasesVulvar Diseases

Study Officials

  • Joanna Yang, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2024

First Posted

September 3, 2024

Study Start

October 4, 2024

Primary Completion

August 8, 2025

Study Completion

August 8, 2025

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)