NCT01667965

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 15, 2015

Status Verified

July 1, 2015

Enrollment Period

2.9 years

First QC Date

August 15, 2012

Last Update Submit

July 13, 2015

Conditions

Keywords

palliative radiation12-172

Outcome Measures

Primary Outcomes (1)

  • create an effective video decision aid

    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

Study Arms (1)

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

Interventions

questionnairesBEHAVIORAL

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.

pts receiving palliative radiation therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Those who have seen the video beforehand

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Beryl McCormack, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2012

First Posted

August 17, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 15, 2015

Record last verified: 2015-07

Locations