Use of a Video Decision Tool to Improve Informed Decision-Making in Hospitalized Patients Considering Palliative Radiation Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01667965
First received: August 15, 2012
Last updated: July 21, 2014
Last verified: July 2014
  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 2015
Estimated Primary Completion Date: August 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667965

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
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: July 21, 2014
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 July 29, 2014