Ride to Care - Quality of Life With Transportation for RT

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Metastatic Malignant Neoplasm; Locally Advanced Malignant Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Supportive Care

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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?"

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Procedure: Supportive Care; Receive Uber rides; Other Names: Supportive Therapy; Symptom Management; Therapy, Supportive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean pain score on the European Organization for Research and Treatment of Cancer quality of life questionnaire 30 (EORTC-QLQ-C30)	The Pain score consists of responses to two items with responses ranging from 1="Not at all" to 4="Very Much". The raw score is calculated by estimating the mean of the two items that make up the pain scale with a resulting total range of 1-4. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score for the pain scale / item represents a high level of symptomatology / problems.	Up to 3 years
Change in mean overall global health status score on the EORTC-QLQ-C30	The global health status score consists of responses to two items with responses ranging from 1="very poor" to 4="excellent". The raw score is calculated by estimating the mean of the two items that make up the global health scale with a resulting total range of 1-7. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score for the global health status represents a higher quality of life.	Up to 3 years
Change in functional domain scores on the EORTC-QLQ-C30	The functional domains measure the quality of life in Physical functioning, Role functioning, Emotional functioning, Cognitive functioning, Social functioning. Scores consists of responses to items with responses ranging from 1="Not at all" to 4="Very Much". The raw score is calculated by estimating the mean of the items that make up each domains with a resulting total range of 1 - 4. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score for the functional domains represents a high level of functioning	Up to 3 years
Percentage of participants who completed total treatment	Measured by the number of patients who complete treatment in the total sample of participants.	Up to 3 years
Median days of treatment delays	Will be tabulated. A Mann-Whitney test will be used to compare the two groups.	Up to 3 years
Number of participants with a reported treatment delay	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 .	Up to 3 years
Number of participants with grade >= 3 acute radiation related adverse events	Treatment-related acute adverse events will be classified using the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and tabulated.	Up to 3 years
Number of participants with grade >= 3 chronic radiation related adverse events	Treatment-related chronic adverse events will be classified using the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and tabulated.	Up to 3 years
Percentage of participant requiring re-treatment	Defined as the number of participants who needed to undergo re-irradiation due to recurrence or progression at the treatment site in the total sample.	Up to 3 years
Overall survival (OS)	Participants will be followed from enrollment until end of study or death, whichever occurs first. OS will be assessed using Cox-proportional Hazard models	Up to 3 years

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Steve Braunstein, MD, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Anticipated): February 4, 2022
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 189820; NCI-2019-00448 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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