Locally Advanced Malignant NeoplasmNCT03849742
Ride to Care - Quality of Life With Transportation for RT
A study testing Quality-of-Life Assessment, Questionnaire Administration and Supportive Care in people with Locally Advanced Malignant Neoplasm and Metastatic Malignant Neoplasm, run by University of California, San Francisco.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm
- What is being tested?
- Quality-of-Life Assessment, Questionnaire Administration and Supportive Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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?
Show all 9Show fewer
- 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?"
Who cannot join
- 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
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To test whether eliminating transportation barriers for disadvantaged cancer patients can reduce the 6-month rate of unplanned emergency department (ED) visits.
SECONDARY OBJECTIVES:
- 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.
- 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.
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration, Supportive Care
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Supportive CareProcedure or surgery
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Receive Uber rides
| Study group | Role | What they receive |
|---|---|---|
| Heath services research (Uber rides) | Experimental | Patients receive Uber rides to and from scheduled radiotherapy appointments for up to 6 months. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 6 months
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Up to 3 years
Median days of treatment delays
Will be tabulated. A Mann-Whitney test will be used to compare the two groups.
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start15 May 2019
- Primary completion4 Feb 2022 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: Low Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve Braunstein, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849742
- Sponsor's protocol ID
- 189820
- Other IDs
- NCI-2019-00448
- Status last verified
- May 2021
- First submitted
- 12 Feb 2019
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03849742
- Acronym / sponsor ID
- 189820
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low Accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 4 Feb 2022 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To test whether eliminating transportation barriers for disadvantaged cancer patients can reduce the 6-month rate of unplanned emergency department (ED) visits.
SECONDARY OBJECTIVES:
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heath services research (Uber rides) | Experimental | Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Supportive CarePatients receive Uber rides to and from scheduled radiotherapy appointments for up to 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Heath services research (Uber rides) |
| Questionnaire AdministrationAncillary studies | Other | Heath services research (Uber rides) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveReceive Uber rides | Procedure or surgery | Heath services research (Uber rides) |
Primary outcome
Rate of unplanned emergency department (ED) visits
Time frame: 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
Time frame: Up to 6 months
For each enrolled patient, any unplanned hospital admission the six months from consultation/enrollment will be documented as an event.
10 secondary outcomes
Change in mean pain score on the European Organization for Research and Treatment of Cancer quality of life questionnaire 30 (EORTC-QLQ-C30)
Time frame: Up to 3 years
Change in mean overall global health status score on the EORTC-QLQ-C30
Time frame: Up to 3 years
Change in functional domain scores on the EORTC-QLQ-C30
Time frame: Up to 3 years
Percentage of participants who completed total treatment
Time frame: Up to 3 years
Median days of treatment delays
Time frame: Up to 3 years
Number of participants with a reported treatment delay
Time frame: Up to 3 years
Number of participants with grade >= 3 acute radiation related adverse events
Time frame: Up to 3 years
Number of participants with grade >= 3 chronic radiation related adverse events
Time frame: Up to 3 years
Percentage of participant requiring re-treatment
Time frame: Up to 3 years
Overall survival (OS)
Time frame: Up to 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Braunstein, MD, PhD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing Quality-of-Life Assessment, Questionnaire Administration and Supportive Care in people with Locally Advanced Malignant Neoplasm and Metastatic Malignant Neoplasm, run by University of California, San Francisco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of unplanned emergency department (ED) visits (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.