Ride to Care - Quality of Life With Transportation for RT

• ClinicalTrials.gov Identifier: NCT03849742
• Recruitment Status: Withdrawn
• First Posted: February 21, 2019
• Last Update Posted: May 14, 2021
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 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, 2022
• Estimated Study Completion Date: December 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Rate of unplanned emergency department (ED) visits [ Time Frame: Up to 6 months ]
   For each enrolled patient, any unplanned ED visit over the six months from consultation/enrollment will be documented as an event.
2. Rate of unplanned hospital admissions [ Time Frame: Up to 6 months ]
   For each enrolled patient, any unplanned hospital admission the six months from consultation/enrollment will be documented as an event.

Secondary Outcome Measures :

1. Change in mean pain score on the European Organization for Research and Treatment of Cancer quality of life questionnaire 30 (EORTC-QLQ-C30) [ Time Frame: Up to 3 years ]
   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.
2. Change in mean overall global health status score on the EORTC-QLQ-C30 [ Time Frame: Up to 3 years ]
   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.
3. Change in functional domain scores on the EORTC-QLQ-C30 [ Time Frame: Up to 3 years ]
   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
4. Percentage of participants who completed total treatment [ Time Frame: Up to 3 years ]
   Measured by the number of patients who complete treatment in the total sample of participants.
5. Median days of treatment delays [ Time Frame: Up to 3 years ]
   Will be tabulated. A Mann-Whitney test will be used to compare the two groups.
6. Number of participants with a reported treatment delay [ Time Frame: Up to 3 years ]
   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 .
7. Number of participants with grade >= 3 acute radiation related adverse events [ Time Frame: Up to 3 years ]
   Treatment-related acute adverse events will be classified using the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and tabulated.
8. Number of participants with grade >= 3 chronic radiation related adverse events [ Time Frame: Up to 3 years ]
   Treatment-related chronic adverse events will be classified using the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and tabulated.
9. Percentage of participant requiring re-treatment [ Time Frame: Up to 3 years ]
   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.
10. Overall survival (OS) [ Time Frame: Up to 3 years ]
    Participants will be followed from enrollment until end of study or death, whichever occurs first. OS will be assessed using Cox-proportional Hazard models

Eligibility Criteria

• 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 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

Contacts and Locations

Sponsors and Collaborators

University of California, San Francisco

Investigators

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

More 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
• Last Update Posted: May 14, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Neoplasms