Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ride to Care - Quality of Life With Transportation for RT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03849742
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Locally Advanced Malignant Neoplasm Metastatic Malignant Neoplasm Other: Quality-of-Life Assessment Other: Questionnaire Administration Procedure: Supportive Care Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To test whether eliminating transportation barriers for disadvantaged cancer patients can reduce the 6-month rate of unplanned emergency department (ED) visits.

SECONDARY OBJECTIVES:

I. To test whether eliminating transportation barriers for disadvantaged cancer patients for the duration of a palliative radiotherapy course will improve prescribed treatment completion rates and reduce treatment delays and overall time to treatment completion.

II. To test whether eliminating transportation barriers for disadvantaged cancer patients for the duration of a palliative radiotherapy course will have an impact on physician choice for therapeutic modality, [3-dimensional conformal radiation therapy (3D CRT) versus intensity-modulated radiation therapy (IMRT) versus stereotactic body radiation therapy (SBRT)] and the fractionation schedules to minimize patient inconvenience.

III. To test whether eliminating transportation barriers for disadvantaged cancer patients for the duration of a palliative radiotherapy course can reduce the short-term (6- months) rate of grade >= 3 radiation related adverse events as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.

IV. To test whether eliminating transportation barriers for disadvantaged cancer patients for the duration of a palliative radiotherapy course can improve the patient?s experience, functional outcome, and overall quality of life as measured by the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)30.

V. To test whether eliminating transportation barriers for disadvantaged cancer patients for the duration of a palliative radiotherapy course can reduce re-treatment rates, improve the progression free survival rates, and overall survival.

VI. To determine if living within San Francisco County versus the surrounding counties (Alameda, Contra Costa, Marin, San Mateo) within the San Francisco Bay Area has an impact on outcomes.

OUTLINE:

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

After completion of study, patients are followed up every 3 months for up to 3 years.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Ride to Care - A Pilot Study to Investigate the Clinical and Quality of Life Benefit of Eliminating Transportation Barriers for Disadvantaged Cancer Patients Undergoing Ambulatory Palliative Radiotherapy
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : February 4, 2021
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: Heath services research (Uber rides)
Patients receive Uber rides to and from scheduled radiotherapy appointments for up to 6 months.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Procedure: Supportive Care
Receive Uber rides
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive




Primary Outcome Measures :
  1. Rate of unplanned emergency department (ED) visits [ Time Frame: Up to 6 months ]
    Perform a student's t-test to compare the number of visits to the ED per individual

  2. Rate of unplanned emergency department (ED) visits [ Time Frame: Up to 6 months ]
    A chi-sq test to evaluate a binary (yes or no) outcome for ED visit.

  3. Rate of unplanned hospital admissions [ Time Frame: Up to 6 months ]
    Perform a student's t-test to compare the number of hospital admissions per individual

  4. Rate of unplanned hospital admissions [ Time Frame: Up to 6 months ]
    A chi-sq test to evaluate a binary (yes or no) outcome for hospital admissions.


Secondary Outcome Measures :
  1. Quantitative change in pain score [ Time Frame: Baseline up to 3 years post study ]
    Measured by the European Organization for Research and Treatment of Cancer [EORTC] quality of life questionnaire [QLQ]30. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

  2. Quantitative change in overall quality of life [ Time Frame: Baseline up to 3 years post study ]
    Will be measured by the European Organization for Research and Treatment of Cancer [EORTC] quality of life questionnaire [QLQ]30. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

  3. Quantitative change in functional domains [ Time Frame: Baseline up to 3 years post study ]
    Will be measured by the European Organization for Research and Treatment of Cancer [EORTC] quality of life questionnaire [QLQ]30. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

  4. Total treatment completion rates [ Time Frame: Up to 3 years post study ]
    Measured by the number of patients who complete treatment

  5. Total treatment completion rates [ Time Frame: Up to 3 years post study ]
    A chi-square test will be used to assess differences

  6. Average/median days of treatment delays [ Time Frame: Up to 3 years post study ]
    Will be tabulated. A Mann-Whitney test will be used to compare the two groups.

  7. Overall treatment delay [ Time Frame: Up to 3 years post study ]
    Will be measured by the ratio of time elapsed to time expected. Patients are assumed to require 2 business days between referral and consult and 3 business days between consult and treatment start. T1/T0, such that time elapsed (T1) = total days between initial referral and treatment completion. Time expected (T0) = 5 + total days of radiation prescribed .

  8. Incidence of any acute grade >= 3 radiation related adverse events [ Time Frame: Up to 3 years post study ]
    Will be measured by the Common Terminology Criteria for Adverse Events CTCAE version 5 and tabulated.

  9. Incidence of any chronic grade >= 3 radiation related adverse events [ Time Frame: Up to 3 years post study ]
    Will be measured by the Common Terminology Criteria for Adverse Events CTCAE version 5 and tabulated.

  10. Re-treatment rates [ Time Frame: Up to 3 years post study ]
    Defined by the number of patients who needed to undergo re-irradiation due to recurrence or progression at the treatment site.

  11. Overall survival (OS) [ Time Frame: Up to 3 years post study ]
    OS will be assessed using Kaplan Meier models

  12. Overall survival (OS) [ Time Frame: Up to 3 years post study ]
    OS will be assessed using Cox-proportional Hazard models



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent (and assent when applicable) obtained from patient or patient?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 >= 2/4 of the questions below:

    • In the last six months, have you ever had to go without health care because you didn?t have a way to get there?
    • Do you put off or neglect going to the doctor because of distance or transportation?
    • Does lack of money for transportation expenses (parking, taxi, bus) make it difficult to get to the doctor?
    • Would it be difficult to find a friend or relative to take you to a doctor?s appointment, if you could not drive/transport yourself?

Exclusion Criteria:

  • 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
  • Patients who are wheel-chair bound or require special assistance in order to under radiation treatment ineligible

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849742


Contacts
Layout table for location contacts
Contact: Steve Braunstein, MD, PhD 415-502-6926 Steve.Braunstein@ucsf.edu
Contact: Jamese Johnson 415-476-8099 Jamese.Johnson@ucsf.edu

Locations
Layout table for location information
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Steve Braunstein, MD, PhD    415-502-6926    Steve.Braunstein@ucsf.edu   
Contact: Jamese Johnson    415-476-8099    jamese.johnson@ucsf.edu   
Principal Investigator: Steve Braunstein, MD, PhD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Steve Braunstein, MD, PhD University of California, San Francisco
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03849742    
Other Study ID Numbers: 189820
NCI-2019-00448 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms