Ride to Care - Quality of Life With Transportation for RT

Locally Advanced Malignant Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03849742
• Other study ID #: 189820
• Secondary ID: NCI-2019-00448
• Status: Withdrawn
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2024
• Est. primary completion date: February 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Malignant Neoplasm
• Metastatic Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Procedure:
• Supportive Care
Receive Uber rides

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Median days of treatment delays	Will be tabulated. A Mann-Whitney test will be used to compare the two groups.	Up to 3 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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