Use of a Video Decision Tool to Improve Informed Decision-Making in Hospitalized Patients Considering Palliative Radiation Therapy
This study is currently recruiting participants.
Verified December 2012 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01667965
First received: August 15, 2012
Last updated: December 12, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Metastatic Cancer or Locally Advanced Patients Receiving Palliative Radiation |
Behavioral: questionnaires |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Use of a Video Decision Tool to Improve Informed Decision-Making in Hospitalized Patients Considering Palliative Radiation Therapy |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- create an effective video decision aid [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 48 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Behavioral: questionnaires
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667965
Contacts
| Contact: Beryl McCormick, MD | 212-639-6828 | |
| Contact: Tomer Levin, MBBS | 646-888-0021 |
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Beryl McCormick, MD 212-639-6828 | |
| Contact: Tomer Levin, MBBS 646-888-0021 | |
| Principal Investigator: Beryl McCormick, MD | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Beryl McCormack, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01667965 History of Changes |
| Other Study ID Numbers: | 12-172 |
| Study First Received: | August 15, 2012 |
| Last Updated: | December 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
palliative radiation 12-172 |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013