Malignant DiseasePROCCNCT03995927
Palliative Radiation Oncology Chief's Clinic
An observational study of Malignant Disease and Metastasis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The proposed study represents a quality improvement study of a recently-developed dedicated radiation oncology subspecialty clinic with the goal of improving timeliness of palliative radiation therapy and improving resident training in palliative care topics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Disease, Metastasis
- What is being tested?
- Data collection and analysis and Quality of Life Questionnaire
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 5 Apr 2020
- Phase
- Observational
- 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
Study population: The study population will be comprised of patients referred to radiation oncology for consideration of palliative radiation therapy
Who may be able to join
- Age 18 years or older
- Clinically or pathologically-defined malignant disease amenable to palliative radiotherapy.
Who cannot join
- Pregnancy. A verbal pregnancy denial will suffice.
- No intention to treat with palliative radiation therapy following initial referral and consult.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Palliative Radiation Oncology Chief's Clinic (PROCC): Assessing the Impact of a Dedicated Clinic on the Timeliness of Palliative Radiotherapy
The proposed study represents a quality improvement study of a recently-developed dedicated radiation oncology subspecialty clinic with the goal of improving timeliness of palliative radiation therapy and improving resident training in palliative care topics. The aim of this study is to evaluate the impact of this clinic on time to palliative radiation therapy following referral.
Read the detailed description
Primary Objective:
- Determine whether interval between palliative radiation therapy referral and palliative radiation therapy initiation is shorter for participants treated in a dedicated palliative radiation oncology clinic compared to the same interval for participants treated in a general radiation oncology clinic (historical control). The investigators' hypothesis is that this interval will be significantly shorter among the Palliative Radiation Oncology Chief's Clinic participants compared to historical control.
Secondary Objectives:
- Determine whether each of the three component intervals within the overall interval from referral to treatment initiation (i.e., referral to consultation; consultation to simulation; simulation to treatment) is shorter for participants treated in a dedicated palliative radiation oncology clinic compared to the length of the same intervals for participants treated in a general radiation oncology clinic (historical control). The investigators' hypothesis is that each of these component intervals will be significantly shorter among the Palliative Radiation Oncology Chief's Clinic participants compared to historical control.
- Describe levels of and changes over time in patient-reported quality of life after palliative radiation therapy in the full sample, and in subgroups stratified by various radiation regimens. The investigators' hypothesis is that participants who receive a shorter course of palliative radiation (one day or five days) will have greater improvements in overall quality of life than participants who receive a ten-day course of palliative radiation.
- Determine median overall survival after palliative radiation therapy.
- Conditions
- Malignant Disease, Metastasis
- Being tested
- Data collection and analysis, Quality of Life Questionnaire
- Keywords
- Difficult to treat cancers
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection and analysisOther
Only radiation oncology patients data from medical records regarding treatment, demographics and follow-up visits will be collected and logged by investigators.
Quality of Life QuestionnaireOther
Participants will be asked to complete a set of short forms at first visit and post-treatment visits. If participant has a routine visit about 3 months after treatment, participant will be asked to complete a final form that is optional.
| Study group | Role | What they receive |
|---|---|---|
| Data collection/questionnaire | Data collection for patient medical charts and patient fill out questionnaires first visit and post-treatment visits Receives: Other: Data collection and analysis; Other: Quality of Life Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days Between Referral and Start of Treatment
Number of days between referral to palliative radiation therapy interval and start of palliative radiation therapy compared to historical control. Mean time from referral to the start of RT (measured in days) will be computed for our sample and compared to the historical control mean of 13.4 days using a two-sided one-sample t-test.
Measured: 3 months
Secondary outcomes (5)
Mean Time from Referral for Consultation
Mean time from referral to consultation will be computed for our sample and compared to the historical control mean of 3.6 days.
Measured: 3 months
Mean Time from Consultation to CT Simulation
Mean time from consultation to CT simulation will be computed for our sample and compared to the historical control mean of 3.8 days.
Measured: 3 months
Mean Time from CT Simulation to Palliative Radiation Start
Mean time from CT simulation to start of PRT will be computed for our sample and compared to the historical control mean of 6.1 days.
Measured: 3 months
Quality of Life Changes
Levels of and changes in patient-reported overall quality of life as measured by the EORTC QLQ-C15-PAL (14 questions) at baseline and at 1-month and 3-month intervals after end of palliative radiation therapy. Quality of life score scale consists of 1 = not at all to 4 = very much. The higher the QOL score the greater change in the participant's quality of life.
Measured: 1 and 3 months after treatment completion
Overall Survival
Median overall survival (number of days between start of radiation therapy and death from any cause) will be estimated using the Kaplan-Meier method and compared (with a one-sample logrank test and assuming a Weibull distribution parameter of 1.0) to the median overall survival of n=134 days in our historical control.
Measured: 6 months after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start15 Jul 2019
- Primary completion28 Jan 2020
- Study completion5 Apr 2020
Why it stopped: PI decision, technical events unrelated to study slowing down the process and ability to accrue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doris Brown, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995927
- Sponsor's protocol ID
- IRB00058996
- Other IDs
- WFBCCC 03419
- Acronym
- PROCC
- Status last verified
- Jun 2023
- First submitted
- 20 Jun 2019
- Last updated
- 29 Jun 2023
- Results posted
- 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 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Radiation Oncology Chief's Clinic (PROCC): Assessing the Impact of a Dedicated Clinic on the Timeliness of Palliative Radiotherapy
- ClinicalTrials.gov ID
- NCT03995927
- Acronym / sponsor ID
- PROCC / IRB00058996
- Conditions
- Malignant Disease, Metastasis
- Keywords
- Difficult to treat cancers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI decision, technical events unrelated to study slowing down the process and ability to accrue
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 5 Apr 2020 (actual)
- First posted
- 24 Jun 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.
The proposed study represents a quality improvement study of a recently-developed dedicated radiation oncology subspecialty clinic with the goal of improving timeliness of palliative radiation therapy and improving resident training in palliative care topics. The aim of this study is to evaluate the impact of this clinic on time to palliative radiation therapy following referral.
Detailed description
Primary Objective:
- Determine whether interval between palliative radiation therapy referral and palliative radiation therapy initiation is shorter for participants treated in a dedicated palliative radiation oncology clinic compared to the same interval for participants treated in a general radiation oncology clinic (historical control). The investigators' hypothesis is that this interval will be significantly shorter among the Palliative Radiation Oncology Chief's Clinic participants compared to historical control.
Secondary Objectives:
- Determine whether each of the three component intervals within the overall interval from referral to treatment initiation (i.e., referral to consultation; consultation to simulation; simulation to treatment) is shorter for participants treated in a dedicated palliative radiation oncology clinic compared to the length of the same intervals for participants treated in a general radiation oncology clinic (historical control). The investigators' hypothesis is that each of these component intervals will be significantly shorter among the Palliative Radiation Oncology Chief's Clinic participants compared to historical control.
- Describe levels of and changes over time in patient-reported quality of life after palliative radiation therapy in the full sample, and in subgroups stratified by various radiation regimens. The investigators' hypothesis is that participants who receive a shorter course of palliative radiation (one day or five days) will have greater improvements in overall quality of life than participants who receive a ten-day course of palliative radiation.
- Determine median overall survival after palliative radiation therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Data collection/questionnaire | – | Other: Data collection and analysis, Other: Quality of Life QuestionnaireData collection for patient medical charts and patient fill out questionnaires first visit and post-treatment visits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be comprised of patients referred to radiation oncology for consideration of palliative radiation therapy
Key inclusion criteria (2 listed)
- Age 18 years or older
- Clinically or pathologically-defined malignant disease amenable to palliative radiotherapy.
Key exclusion criteria (2 listed)
- Pregnancy. A verbal pregnancy denial will suffice.
- No intention to treat with palliative radiation therapy following initial referral and consult.
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 |
|---|---|---|
| Data collection and analysisOnly radiation oncology patients data from medical records regarding treatment, demographics and follow-up visits will be collected and logged by investigators. | Other | Data collection/questionnaire |
| Quality of Life QuestionnaireParticipants will be asked to complete a set of short forms at first visit and post-treatment visits. If participant has a routine visit about 3 months after treatment, participant will be asked to complete a final form that is optional. | Other | Data collection/questionnaire |
Primary outcome
Number of Days Between Referral and Start of Treatment
Time frame: 3 months
Number of days between referral to palliative radiation therapy interval and start of palliative radiation therapy compared to historical control. Mean time from referral to the start of RT (measured in days) will be computed for our sample and compared to the historical control mean of 13.4 days using a two-sided one-sample t-test.
5 secondary outcomes
Mean Time from Referral for Consultation
Time frame: 3 months
Mean Time from Consultation to CT Simulation
Time frame: 3 months
Mean Time from CT Simulation to Palliative Radiation Start
Time frame: 3 months
Quality of Life Changes
Time frame: 1 and 3 months after treatment completion
Overall Survival
Time frame: 6 months after treatment completion
Results and safety
The study was stopped early (reason given: PI decision, technical events unrelated to study slowing down the process and ability to accrue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- 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.
Doris Brown, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Disease and Metastasis, run by Wake Forest University Health Sciences at 1 site in United States.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: PI decision, technical events unrelated to study slowing down the process and ability to accrue). Results are not available in the source record.
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?
Number of Days Between Referral and Start of Treatment (time frame: 3 months). 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 29 Jun 2023.