An interventional study of Quality-of-Life Assessment and Questionnaire Administration in Locally Advanced Malignant Neoplasm and Metastatic Malignant Neoplasm, sponsored by University of California, San Francisco. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-14.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Health services research
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.
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.
3,564 studies on the registry are indexed under Neoplasm Metastasis; 875 are open to participants now.
Browse Neoplasm Metastasis studies →University of California, San Francisco is the lead sponsor of 2,164 studies on the registry; 368 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 199 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
If patient answers yes to >= 1/4 of the questions below:
Exclusion Criteria:
Patients receive Uber rides to and from scheduled radiotherapy appointments for up to 6 months.
Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Procedure: Supportive Care
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Receive Uber rides
Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive
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.
Time frame: Up to 6 months
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.
Time frame: Up to 6 months
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.
Time frame: Up to 3 years
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.
Time frame: Up to 3 years
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
Time frame: Up to 3 years
Percentage of participants who completed total treatment
Measured by the number of patients who complete treatment in the total sample of participants.
Time frame: Up to 3 years
Median days of treatment delays
Will be tabulated. A Mann-Whitney test will be used to compare the two groups.
Time frame: Up to 3 years
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 .
Time frame: Up to 3 years
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.
Time frame: Up to 3 years
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.
Time frame: Up to 3 years
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.
Time frame: Up to 3 years
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
Time frame: Up to 3 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, San Francisco →