Clinical trial NCT03849742: Ride to Care - Quality of Life With Transportation for RT
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Locally Advanced Malignant Neoplasm
Metastatic Malignant Neoplasm
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Rate of unplanned emergency department (ED) visits
timeFrame: Up to 6 months
measure: Rate of unplanned hospital admissions
timeFrame: Up to 6 months
Secondary outcomes:
measure: Change in mean pain score on the European Organization for Research and Treatment of Cancer quality of life questionnaire 30 (EORTC-QLQ-C30)
timeFrame: Up to 3 years
measure: Change in mean overall global health status score on the EORTC-QLQ-C30
timeFrame: Up to 3 years
measure: Change in functional domain scores on the EORTC-QLQ-C30
timeFrame: Up to 3 years
measure: Percentage of participants who completed total treatment
timeFrame: Up to 3 years
measure: Median days of treatment delays
timeFrame: Up to 3 years
measure: Number of participants with a reported treatment delay
timeFrame: Up to 3 years
measure: Number of participants with grade >= 3 acute radiation related adverse events
timeFrame: Up to 3 years
measure: Number of participants with grade >= 3 chronic radiation related adverse events
timeFrame: Up to 3 years
measure: Percentage of participant requiring re-treatment
timeFrame: Up to 3 years
measure: Overall survival (OS)
timeFrame: Up to 3 years
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Steve Braunstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: