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

NCT01760941 | Terminated Results DMC

• 2 other identifiers: MCC-14596NCI-2012-03117
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptomatic Osseous Bone Lesions From Any Malignancy

Keywords

Urology; Prostate; Breast; Lung; Chest

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Evaluate the Treatment Influence on the Rate of Pain Stabilization and/or Reduction

  2 weeks

• Evaluate the Treatment Influence on Patient Quality of Life

  2 weeks

Other Outcomes (1)

• Quantify the Percentage of Patients Receiving the Treatment Who Believe That the Treatment Was Worthwhile

  6 months

Study Arms (1)

Treatment (radiation therapy)

EXPERIMENTAL

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; Other: Quality-of-Life Assessment; Other: Survey Administration

Interventions

Radiation Therapy RADIATION

Undergo standard of care radiation therapy

Also known as: RT, Irradiation

Treatment (radiation therapy)

Quality-of-Life Assessment OTHER

The patient quality of life as measured by the ESAS-r; Edmonton Symptom Assessment System revised.

Treatment (radiation therapy)

Survey Administration OTHER

The surveys consists of Radiation Therapy Worthfullness survey; BPI: brief pain inventory; NUS: narcotics usage survey.

Treatment (radiation therapy)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Interventions

Radiotherapy; Radiation

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

Limitations and Caveats

No data analysis or outcome measures for one participant enrolled and zero participants analyzed. Early suspension and termination due to slow accrual from Protocol Review and Monitoring Committee.

Results Point of Contact

• Title: Drew Moghanaki, MD, MPH
• Organization: Virginia Commonwealth University/Massey Cancer Center

Drew.moghanaki@vcuhealth.org

804-765-5850

Study Officials

• Drew Moghanaki, MD, MPH

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: January 4, 2013
• Study Start: March 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 29, 2016
• Results First Posted: February 29, 2016

Record last verified: 2016-01

Locations

US (1)