Symptomatic Osseous Bone Lesions From Any MalignancyNCT01760941
Compassionate Same-Day Evaluation & Delivery of XRT for Bony Metastasis in Hospice Patients
A study testing Radiation Therapy, Quality-of-Life Assessment and Survey Administration in people with Symptomatic Osseous Bone Lesions From Any Malignancy, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Osseous Bone Lesions From Any Malignancy
- What is being tested?
- Radiation Therapy, Quality-of-Life Assessment and Survey Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy.
- Unable to understand English.
- Unable to complete forms with assistance.
- Concurrent enrollment in a study of pain management involving medications or devices.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
About this study
Official title: Feasibility of a Compassionate Same-Day Evaluation and Delivery of Single Fraction Radiotherapy for Palliation of Symptomatic Bony Metastasis in Hospice Patients
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.
- Being tested
- Radiation Therapy, Quality-of-Life Assessment, Survey Administration
- Keywords
- Urology, Prostate, Breast, Lung, Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Also called RT, Irradiation
Undergo standard of care radiation therapy
Quality-of-Life AssessmentOther
The patient quality of life as measured by the ESAS-r; Edmonton Symptom Assessment System revised.
Survey AdministrationOther
The surveys consists of Radiation Therapy Worthfullness survey; BPI: brief pain inventory; NUS: narcotics usage survey.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Radiation Therapy; Other: Quality-of-Life Assessment; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 6 months
Secondary outcomes (2)
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.
Measured: 2 weeks
Evaluate the Treatment Influence on Patient Quality of Life
Evaluate the treatment influence on patient quality of life as measured by the ESAS.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2015
- Study completionJun 2015
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Symptomatic Osseous Bone Lesions From Any MalignancyStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Drew Moghanaki, MD, MPH, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760941
- Sponsor's protocol ID
- MCC-14596
- Other IDs
- NCI-2012-03117
- Status last verified
- Jan 2016
- First submitted
- 20 Dec 2012
- Last updated
- 29 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Compassionate Same-Day Evaluation and Delivery of Single Fraction Radiotherapy for Palliation of Symptomatic Bony Metastasis in Hospice Patients
- ClinicalTrials.gov ID
- NCT01760941
- Acronym / sponsor ID
- MCC-14596
- Keywords
- Urology, Prostate, Breast, Lung, Chest
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Posted 29 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (radiation therapy) | Experimental | Radiation: Radiation Therapy, Other: Quality-of-Life Assessment, Other: Survey AdministrationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy.
- Unable to understand English.
- Unable to complete forms with assistance.
- Concurrent enrollment in a study of pain management involving medications or devices.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation TherapyAlso: RT, IrradiationUndergo standard of care radiation therapy | Radiation | Treatment (radiation therapy) |
| Quality-of-Life AssessmentThe patient quality of life as measured by the ESAS-r; Edmonton Symptom Assessment System revised. | Other | Treatment (radiation therapy) |
| Survey AdministrationThe surveys consists of Radiation Therapy Worthfullness survey; BPI: brief pain inventory; NUS: narcotics usage survey. | Other | Treatment (radiation therapy) |
Primary outcome
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
2 secondary outcomes
Evaluate the Treatment Influence on the Rate of Pain Stabilization and/or Reduction
Time frame: 2 weeks
Evaluate the Treatment Influence on Patient Quality of Life
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Drew Moghanaki, MD, MPH principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation Therapy, Quality-of-Life Assessment and Survey Administration in people with Symptomatic Osseous Bone Lesions From Any Malignancy, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Treatment Delivery in the Same Day as Initial Evaluation (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2016.