- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01667965
Use of a Video Decision Tool to Improve Informed Decision-Making in Hospitalized Patients Considering Palliative Radiation Therapy
July 13, 2015 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to assess the effectiveness and acceptability of a recently created informative video geared for patients who have been evaluated by a radiation oncologist for palliative radiation therapy during a hospitalization at Memorial Sloan-Kettering Cancer Center.
Palliative radiation therapy is radiation therapy that is given to patients with the purpose of easing symptoms from cancer.
It is not given with the intent to cure the cancer.
The video presents basic information about palliative radiation and palliative care.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
43
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Inpatients will be approached regarding study enrollment at the time that they are evaluated by the inpatient radiation oncology team for palliative radiation therapy.
Description
Inclusion Criteria:
- Age ≥18 years
- Eligible for palliative radiation to the brain, spine, chest, abdomen, pelvis, skin, or bone as per the judgment of the radiation oncologist or nurse practitioner
- Patient is English-speaking and able to give informed consent and fill out study questionnaires
- Hospitalized at MSKCC
- Pathologically confirmed malignancy
- Cancer is metastatic or locally advanced, and is not curable
- Patients who may undergo radiation at a satellite facility are still eligible for protocol enrollment
Exclusion Criteria:
- Those who have seen the video beforehand
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
pts receiving palliative radiation therapy
The design of the study will be a prospective non-randomized cohort study with structured questionnaires administered to all enrolled patients at two or three time-points.
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Questionnaires will be given before the patient watches a video educational tool to aid informed consent about palliative radiation therapy; and (2) after the patient watches the video educational tool.
(3) If the patient receives PRT, a final questionnaire that assesses the patient's impression of the video will also be administered at the conclusion of radiation therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
create an effective video decision aid
Time Frame: 1 year
|
Effectiveness of the video tool will be assessed by the following measures before and after watching the video.
The pre- and post-assessment design comparing uncertainty, knowledge and preference scores of a video explaining palliative radiation and palliative care.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Beryl McCormack, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
August 15, 2012
First Submitted That Met QC Criteria
August 15, 2012
First Posted (Estimate)
August 17, 2012
Study Record Updates
Last Update Posted (Estimate)
July 15, 2015
Last Update Submitted That Met QC Criteria
July 13, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-172
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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