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

This study has suspended participant recruitment.
(focus on raising awareness in the community about the program then re-open study)
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01760941
First received: December 20, 2012
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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 Intervention
Symptomatic Osseous Bone Lesions From Any Malignancy
Radiation: Radiotherapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Feasibility of treatment delivery in the same day as initial evaluation [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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:
  • Evaluate the treatment influence on the rate of pain stabilization and/or reduction [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Evaluate the treatment influence on the rate of pain stabilization and/or reduction as measured by the validated BPI patient questionnaire.

  • Evaluate the treatment influence on patient quality of life [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Evaluate the treatment influence on patient quality of life as measured by the ESAS.


Other Outcome Measures:
  • Quantify the percentage of patients receiving the treatment who believe that the treatment was worthwhile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Quantify the percentage of patients receiving the treatment who believe that the treatment was worthwhile


Estimated Enrollment: 21
Study Start Date: March 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Radiotherapy
Single fraction radiotherapy
Radiation: Radiotherapy
Single fraction radiotherapy
Other Name: Single fraction radiotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760941

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

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01760941     History of Changes
Other Study ID Numbers: MCC-14596, NCI-2012-03117
Study First Received: December 20, 2012
Last Updated: December 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Urology
Prostate
Breast
Lung
Chest

ClinicalTrials.gov processed this record on September 18, 2014