Compassionate Same-Day Evaluation & Delivery of XRT for Bony Metastasis in Hospice Patients

• ClinicalTrials.gov Identifier: NCT01760941
• Recruitment Status: Terminated
• First Posted: January 4, 2013
• Results First Posted: February 29, 2016
• Last Update Posted: February 29, 2016
• Sponsor: Virginia Commonwealth University
• Information provided by (Responsible Party): Virginia Commonwealth University

Study Description

Brief Summary:

This is a survey study to evaluate the feasibility and effectiveness of an affordable, $400 flat rate, same-day consultation, simulation, and delivery of a single fraction of palliative radiation therapy for patients with symptomatic bony metastatic disease who are currently enrolled in hospice. Treatment planning and delivery of palliative radiotherapy will utilize "standard of care" techniques.

Condition or disease	Intervention/treatment	Phase
Symptomatic Osseous Bone Lesions From Any Malignancy	Radiation: Radiation Therapy; Other: Quality-of-Life Assessment; Other: Survey Administration	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Feasibility of a Compassionate Same-Day Evaluation and Delivery of Single Fraction Radiotherapy for Palliation of Symptomatic Bony Metastasis in Hospice Patients
• Study Start Date: March 2013
• Actual Primary Completion Date: January 2015
• Actual Study Completion Date: June 2015

Arms and Interventions

Arm

Intervention/treatment

Experimental: Treatment (radiation therapy); This is a survey study to evaluate the feasibility and effectiveness of an affordable, $400 flat rate, same-day consultation, simulation, and delivery of a single fraction of palliative radiation therapy for patients with symptomatic bony metastatic disease who are currently enrolled in hospice. Treatment planning and delivery of palliative radiotherapy will utilize "standard of care" techniques. A physician survey of feasibility will be conducted on the treatment day. Patient surveys will conducted on the day of treatment and at 2 weeks, 4 weeks, 2 months, 3 months, 4 months, 5 months, and 6 months after treatment.

Radiation: Radiation Therapy; Undergo standard of care radiation therapy; Other Names: RT; Irradiation; Other: Quality-of-Life Assessment; The patient quality of life as measured by the ESAS-r; Edmonton Symptom Assessment System revised.; Other: Survey Administration; The surveys consists of Radiation Therapy Worthfullness survey; BPI: brief pain inventory; NUS: narcotics usage survey.

Outcome Measures

Primary Outcome Measures :

1. Feasibility of Treatment Delivery in the Same Day as Initial Evaluation [ Time Frame: Up to 6 months ]
   Patient evaluation will consist of surveys conducted at the time of treatment measured by the Radiation Oncologist Evaluation and Feasibility Assessments survey

Secondary Outcome Measures :

1. Evaluate the Treatment Influence on the Rate of Pain Stabilization and/or Reduction [ Time Frame: 2 weeks ]
   Evaluate the treatment influence on the rate of pain stabilization and/or reduction as measured by the validated BPI patient questionnaire.
2. Evaluate the Treatment Influence on Patient Quality of Life [ Time Frame: 2 weeks ]
   Evaluate the treatment influence on patient quality of life as measured by the ESAS.

Other Outcome Measures:

1. Quantify the Percentage of Patients Receiving the Treatment Who Believe That the Treatment Was Worthwhile [ Time Frame: 6 months ]
   Quantify the percentage of patients receiving the treatment who believe that the treatment was worthwhile

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Symptomatic osseous bone lesion(s) from any malignancy, whether primary of metastatic, with histological confirmation of malignancy.
• Currently enrolled in hospice and referred for single fraction palliative radiotherapy.
• Performance status (to be evaluated by the radiation oncologist), Karnofsky Performance Scale ≥ 20 or ECOG Performance Scale < 5 .
• Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

• Pregnancy.
• Unable to understand English.
• Unable to complete forms with assistance.
• Concurrent enrollment in a study of pain management involving medications or devices.

Contacts and Locations

Locations

United States, Virginia

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

• Principal Investigator: Drew Moghanaki, MD, MPH; Virginia Commonwealth University

More Information

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT01760941 History of Changes
• Other Study ID Numbers: MCC-14596; NCI-2012-03117 ( Registry Identifier: NCI CTRP )
• First Posted: January 4, 2013
• Results First Posted: February 29, 2016
• Last Update Posted: February 29, 2016
• Last Verified: January 2016

Keywords provided by Virginia Commonwealth University:

Urology; Prostate; Breast; Lung; Chest

Additional relevant MeSH terms:

Neoplasm Metastasis; Neoplasms; Neoplastic Processes; Pathologic Processes