Clinical trial NCT03995927: Palliative Radiation Oncology Chief's Clinic
Official title: Palliative Radiation Oncology Chief's Clinic (PROCC): Assessing the Impact of a Dedicated Clinic on the Timeliness of Palliative Radiotherapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Malignant Disease
Metastasis
Keywords: Difficult to treat cancers
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be comprised of patients referred to radiation oncology for consideration of palliative radiation therapy

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Days Between Referral and Start of Treatment
timeFrame: 3 months
Secondary outcomes:
measure: Mean Time from Referral for Consultation
timeFrame: 3 months
measure: Mean Time from Consultation to CT Simulation
timeFrame: 3 months
measure: Mean Time from CT Simulation to Palliative Radiation Start
timeFrame: 3 months
measure: Quality of Life Changes
timeFrame: 1 and 3 months after treatment completion
measure: Overall Survival
timeFrame: 6 months after treatment completion
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Doris Brown, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: