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Palliative Radiation Oncology Chief's Clinic (PROCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995927
Recruitment Status : Active, not recruiting
First Posted : June 24, 2019
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Malignant Disease Metastasis Other: Data collection and analysis Other: Quality of Life Questionnaire

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.

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Palliative Radiation Oncology Chief's Clinic (PROCC): Assessing the Impact of a Dedicated Clinic on the Timeliness of Palliative Radiotherapy
Actual Study Start Date : July 15, 2019
Actual Primary Completion Date : January 28, 2020
Estimated Study Completion Date : July 2020

Group/Cohort Intervention/treatment
Data collection/questionnaire
Data collection for patient medical charts and patient fill out questionnaires first visit and post-treatment visits
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.

Other: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Mean Time from Referral for Consultation [ Time Frame: 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.

  2. Mean Time from Consultation to CT Simulation [ Time Frame: 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.

  3. Mean Time from CT Simulation to Palliative Radiation Start [ Time Frame: 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.

  4. Quality of Life Changes [ Time Frame: 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.

  5. Overall Survival [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will be comprised of patients referred to radiation oncology for consideration of palliative radiation therapy
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995927


Locations
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United States, North Carolina
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Doris Brown, MD, PhD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03995927    
Other Study ID Numbers: IRB00058996
WFBCCC 03419 ( Other Identifier: Wake Forest Baptist Comprehensive Cancer Center )
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Difficult to treat cancers
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes