NCT03849742

Brief Summary

This trial studies how well Uber health intervention works in eliminating transportation barriers for disadvantaged patients with cancer that has spread to nearby tissue, lymph nodes, or other places in the body, undergoing ambulatory palliative radiotherapy. Uber health intervention provides free transportation to disadvantaged patients and may reduce the amount of missed radiotherapy appointments, patient anxiety, and the amount of unplanned emergency department visits, as well as improve quality of life.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Status
withdrawn

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

February 12, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2022

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 14, 2021

Status Verified

May 1, 2021

Enrollment Period

2.7 years

First QC Date

February 12, 2019

Last Update Submit

May 12, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Rate of unplanned emergency department (ED) visits

    For each enrolled patient, any unplanned ED visit over the six months from consultation/enrollment will be documented as an event.

    Up to 6 months

  • Rate of unplanned hospital admissions

    For each enrolled patient, any unplanned hospital admission the six months from consultation/enrollment will be documented as an event.

    Up to 6 months

Secondary Outcomes (10)

  • Change in mean pain score on the European Organization for Research and Treatment of Cancer quality of life questionnaire 30 (EORTC-QLQ-C30)

    Up to 3 years

  • Change in mean overall global health status score on the EORTC-QLQ-C30

    Up to 3 years

  • Change in functional domain scores on the EORTC-QLQ-C30

    Up to 3 years

  • Percentage of participants who completed total treatment

    Up to 3 years

  • Median days of treatment delays

    Up to 3 years

  • +5 more secondary outcomes

Study Arms (1)

Heath services research (Uber rides)

EXPERIMENTAL

Patients receive Uber rides to and from scheduled radiotherapy appointments for up to 6 months.

Other: Quality-of-Life AssessmentOther: Questionnaire AdministrationProcedure: Supportive Care

Interventions

Ancillary studies

Also known as: Quality of Life Assessment
Heath services research (Uber rides)

Ancillary studies

Heath services research (Uber rides)

Receive Uber rides

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive
Heath services research (Uber rides)

Eligibility Criteria

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

You may qualify if:

  • Written informed consent (and assent when applicable) obtained from patient or patients's legal representative and ability for patient to comply with the requirements of the study
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Histologically confirmed locally advanced or metastatic cancer
  • Patients who have received prior courses of radiotherapy are eligible
  • If patient answers yes to \>= 1/4 of the questions below:
  • In the last six months, have you ever delayed seeing a doctor or getting care?
  • Do you anticipate having a hard time coming to University of California, San Francisco (UCSF) for radiation therapy due to transportation challenges?
  • Does lack of money for transportation expenses (parking, taxi, bus) make it difficult for you to get care quickly for medical problems?
  • Does arranging for transportation (driving yourself, getting neighbor or family to drive you) for your cancer treatments make you anxious or worried?"

You may not qualify if:

  • Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
  • Patients who are living at a facility such as a nursing home or skilled nursing facility
  • Patients who do not live within a 30-mile radius of one of the radiation oncology sites at University of California San Francisco (UCSF)
  • Patients who are currently receiving or expected to be receive UCSF affiliated transportation services prior to enrollment onto the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Steve Braunstein, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

February 12, 2019

First Posted

February 21, 2019

Study Start

May 15, 2019

Primary Completion

February 4, 2022

Study Completion

December 31, 2024

Last Updated

May 14, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share