Palliative Radiation Oncology Chief's Clinic

NCT03995927 | Terminated

• 2 other identifiers: IRB00058996WFBCCC 03419
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Disease; Metastasis

Keywords

Difficult to treat cancers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Mean Time from Referral for Consultation

  3 months

• Mean Time from Consultation to CT Simulation

  3 months

• Mean Time from CT Simulation to Palliative Radiation Start

  3 months

• Quality of Life Changes

  1 and 3 months after treatment completion

• Overall Survival

  6 months after treatment completion

Study Arms (1)

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; Other: Quality of Life Questionnaire

Interventions

Data collection and analysis OTHER

Only radiation oncology patients data from medical records regarding treatment, demographics and follow-up visits will be collected and logged by investigators.

Data collection/questionnaire

Quality of Life Questionnaire OTHER

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.

Data collection/questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will be comprised of patients referred to radiation oncology for consideration of palliative radiation therapy

You may qualify if:

• Age 18 years or older
• Clinically or pathologically-defined malignant disease amenable to palliative radiotherapy.

You may not qualify if:

• Pregnancy. A verbal pregnancy denial will suffice.
• No intention to treat with palliative radiation therapy following initial referral and consult.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Doris Brown, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 24, 2019
• Study Start: July 15, 2019
• Primary Completion: January 28, 2020
• Study Completion: April 5, 2020
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)