Locally Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm
Conditions
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.
Interventions
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
PROCEDURESupportive Care
Receive Uber rides
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of unplanned emergency department (ED) visits | 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. |
| Rate of unplanned hospital admissions | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in functional domain scores on the EORTC-QLQ-C30 | 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 |
| Percentage of participants who completed total treatment | Up to 3 years | Measured by the number of patients who complete treatment in the total sample of participants. |
| Median days of treatment delays | Up to 3 years | Will be tabulated. A Mann-Whitney test will be used to compare the two groups. |
| Number of participants with a reported treatment delay | 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 . |
| Change in mean pain score on the European Organization for Research and Treatment of Cancer quality of life questionnaire 30 (EORTC-QLQ-C30) | 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. |
| Number of participants with grade >= 3 chronic radiation related adverse events | 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. |
| Percentage of participant requiring re-treatment | 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. |
| Overall survival (OS) | 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 |
| Number of participants with grade >= 3 acute radiation related adverse events | 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. |
| Change in mean overall global health status score on the EORTC-QLQ-C30 | 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. |
Outcome results
None listed