Ride to Care - Quality of Life With Transportation for RT

NCT ID: NCT03849742

Last Updated: 2021-05-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-15
• Study Completion Date: 2024-12-31

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.

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.

Conditions

Locally Advanced Malignant Neoplasm; Metastatic Malignant Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Heath services research (Uber rides)

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

Group Type: EXPERIMENTAL

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Supportive Care

Intervention Type: PROCEDURE

Receive Uber rides

Interventions

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Supportive Care

Receive Uber rides

Intervention Type: PROCEDURE

Other Intervention Names

Quality of Life Assessment; Supportive Therapy; Symptom Management; Therapy, Supportive

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve Braunstein, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Other Identifiers

NCI-2019-00448

Identifier Type: REGISTRY

Identifier Source: secondary_id

189820

Identifier Type: -

Identifier Source: org_study_id