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

Symptomatic Osseous Bone Lesions From Any Malignancy Clinical Trial

Official title:

Feasibility of a Compassionate Same-Day Evaluation and Delivery of Single Fraction Radiotherapy for Palliation of Symptomatic Bony Metastasis in Hospice Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01760941
• Other study ID #: MCC-14596
• Secondary ID: NCI-2012-03117
• Status: Terminated
• Phase: N/A
• First received: December 20, 2012
• Last updated: January 29, 2016
• Start date: March 2013
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Symptomatic Osseous Bone Lesions From Any Malignancy

Intervention

Radiation:
• Radiation Therapy
Undergo standard of care radiation therapy

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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quantify the Percentage of Patients Receiving the Treatment Who Believe That the Treatment Was Worthwhile	Quantify the percentage of patients receiving the treatment who believe that the treatment was worthwhile	6 months	No
Primary	Feasibility of Treatment Delivery in the Same Day as Initial Evaluation	Patient evaluation will consist of surveys conducted at the time of treatment measured by the Radiation Oncologist Evaluation and Feasibility Assessments survey	Up to 6 months	No
Secondary	Evaluate the Treatment Influence on the Rate of Pain Stabilization and/or Reduction	Evaluate the treatment influence on the rate of pain stabilization and/or reduction as measured by the validated BPI patient questionnaire.	2 weeks	No
Secondary	Evaluate the Treatment Influence on Patient Quality of Life	Evaluate the treatment influence on patient quality of life as measured by the ESAS.	2 weeks	No