Palliative Radiation Oncology Chief's Clinic

Metastasis Clinical Trial

— PROCC  

Official title:

Palliative Radiation Oncology Chief's Clinic (PROCC): Assessing the Impact of a Dedicated Clinic on the Timeliness of Palliative Radiotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03995927
• Other study ID #: IRB00058996
• Secondary ID: WFBCCC 03419
• Status: Terminated
• Start date: July 15, 2019
• Est. completion date: April 5, 2020

Study information

• Verified date: June 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The aim of this study is to evaluate the impact of this clinic on time to palliative radiation therapy following referral.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: April 5, 2020
• Est. primary completion date: January 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Clinically or pathologically-defined malignant disease amenable to palliative radiotherapy.

Exclusion Criteria:

• Pregnancy. A verbal pregnancy denial will suffice.

• No intention to treat with palliative radiation therapy following initial referral and consult.

Related Conditions & MeSH terms

• Malignant Disease
• Metastasis
• Neoplasm Metastasis

Intervention

Other:
• Data collection and analysis
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 Questionnaire
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.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	1 and 3 months after treatment completion
Secondary	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.	6 months after treatment completion