Palliative Radiation Oncology Chief's Clinic
- Conditions
- Malignant DiseaseMetastasis
- Interventions
- Other: Data collection and analysisOther: Quality of Life Questionnaire
- Registration Number
- NCT03995927
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
- Age 18 years or older
- Clinically or pathologically-defined malignant disease amenable to palliative radiotherapy.
- Pregnancy. A verbal pregnancy denial will suffice.
- No intention to treat with palliative radiation therapy following initial referral and consult.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Data collection/questionnaire Quality of Life Questionnaire Data collection for patient medical charts and patient fill out questionnaires first visit and post-treatment visits Data collection/questionnaire Data collection and analysis Data collection for patient medical charts and patient fill out questionnaires first visit and post-treatment visits
- Primary Outcome Measures
Name Time Method Number of Days Between Referral and Start of Treatment 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.
- Secondary Outcome Measures
Name Time Method Mean Time from Consultation to CT Simulation 3 months Mean time from consultation to CT simulation will be computed for our sample and compared to the historical control mean of 3.8 days.
Mean Time from CT Simulation to Palliative Radiation Start 3 months 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.
Mean Time from Referral for Consultation 3 months Mean time from referral to consultation will be computed for our sample and compared to the historical control mean of 3.6 days.
Quality of Life Changes 1 and 3 months after treatment completion 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.
Overall Survival 6 months after treatment completion 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.
Trial Locations
- Locations (1)
Wake Forest Baptist Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States