Multimedia Psychoeducation or Print Education in Preparing Cancer Patients for Decision Making About Clinical Trials
NCT ID: NCT02054715
Last Updated: 2021-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
418 participants
INTERVENTIONAL
2014-05-01
2016-11-30
Brief Summary
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Detailed Description
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I. To determine the effect of intervention assignment on patients' preparedness for decision making about clinical trial participation.
SECONDARY OBJECTIVES:
I. To determine the effect of intervention assignment on indicators of the quality of patients' decision making about clinical trial participation.
II. To examine mechanisms by which multimedia psychoeducation (MP) exerts its expected positive effects on preparedness for decision making.
TERTIARY OBJECTIVES:
I. To explore the effects of intervention assignment on clinical trial participation.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the National Cancer Institute (NCI) booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.
ARM II: Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a digital video disk (DVD) and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.
After completion of study, patients are followed up at 3-7 and 49-56 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Arm I (print educational)
Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.
print educational intervention
print educational intervention
Arm II (multimedia psychoeducational)
Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.
multimedia psychoeducational intervention
multimedia psychoeducational intervention
Interventions
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print educational intervention
print educational intervention
multimedia psychoeducational intervention
multimedia psychoeducational intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be diagnosed with cancer
* Have been informed of their eligibility for a specific phase II or III therapeutic clinical trial open for enrollment at the participating NCI Community Oncology Research Program (NCORP) site
* Have already met one or more eligibility criteria and have a reasonable expectation of meeting any remaining eligibility criteria for the therapeutic clinical trial
* Be capable of providing written informed consent for study participation
Exclusion Criteria
* Participants must not have already made a decision to participate in the phase II or III therapeutic clinical trial for which they were informed of their eligibility
* Participants must not have documented or observable visual, auditory, psychiatric, or neurological disorders that would interfere with study participation (e.g., blindness, deafness, psychosis, or dementia)
* Participants must not be eligible only for phase I trial; these patients are excluded because few of these trials are offered at NCORP sites and because their design and goals differ considerably from those of phase II and III trials
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gary Morrow
OTHER
Responsible Party
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Gary Morrow
Director
Principal Investigators
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Paul Jacobsen
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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San Diego State University
San Diego, California, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Hawaii MU-NCORP
Honolulu, Hawaii, United States
Heartland NCORP
Decatur, Illinois, United States
Kansas City Clinical Oncology Program
Prairie Village, Kansas, United States
Gulf South MU-NCORP
New Orleans, Louisiana, United States
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, United States
Metro MN NCORP
Minneapolis, Minnesota, United States
Nevada Cancer Research Foundation NCORP
Las Vegas, Nevada, United States
Nevada NCORP
Las Vegas, Nevada, United States
URCC / University of Rochester NCORP Research Base
Rochester, New York, United States
Southeast Clinical Oncology Research Consortium
Winston-Salem, North Carolina, United States
Columbus NCORP
Columbus, Ohio, United States
Dayton Community Oncology Program
Dayton, Ohio, United States
Geisinger Cancer Institute NCORP
Danville, Pennsylvania, United States
Greenville Health System Cancer Instutite/Greenville NCORP
Greenville, South Carolina, United States
Wisconsin NCORP
Marshfield, Wisconsin, United States
Aurora NCORP
Milwaukee, Wisconsin, United States
Countries
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Related Links
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Description: Clinical trial summary from the National Cancer Institute's PDQ® database
Other Identifiers
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NCI-2013-02237
Identifier Type: REGISTRY
Identifier Source: secondary_id
URCC12107
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-12107
Identifier Type: OTHER
Identifier Source: secondary_id
URCC12107
Identifier Type: -
Identifier Source: org_study_id
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