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

NCT ID: NCT01760941

Last Updated: 2016-02-29

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Symptomatic Osseous Bone Lesions From Any Malignancy

Keywords

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Urology Prostate Breast Lung Chest

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Radiation Therapy

Intervention Type RADIATION

Undergo standard of care radiation therapy

Quality-of-Life Assessment

Intervention Type OTHER

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

Survey Administration

Intervention Type OTHER

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

Interventions

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Radiation Therapy

Undergo standard of care radiation therapy

Intervention Type RADIATION

Quality-of-Life Assessment

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

Intervention Type OTHER

Survey Administration

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

Intervention Type OTHER

Other Intervention Names

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RT Irradiation

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Drew Moghanaki, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2012-03117

Identifier Type: REGISTRY

Identifier Source: secondary_id

MCC-14596

Identifier Type: -

Identifier Source: org_study_id