Clinical trial NCT02054715: Multimedia Psychoeducation or Print Education in Preparing Cancer Patients for Decision Making About Clinical Trials
Official title: Evaluation of Psychoeducation for Cancer Patients Eligible for Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-02-04
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized clinical trial compares multimedia psychoeducation to print education in preparing patients with cancer for decision making about clinical trial participation. Multimedia psychoeducation includes a digital video disc (DVD) and written materials with a combined focus on knowledge and attitude change, and may be an effective method to help patients prepare for decision making about clinical trial participation. It is not yet known whether a multimedia psychoeducation is more effective than print education in preparing patients for decision making about clinical trials.

Detailed description: PRIMARY OBJECTIVES:

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.

Eligibility criteria: Inclusion Criteria:

* Be able to speak and read English
* 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 been asked previously to participate in another therapeutic cancer clinical trial
* 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

Primary outcomes:
measure: Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale
timeFrame: Day 3 to 7
Secondary outcomes:
measure: The Decision Regret Scale (DRS)
timeFrame: Day 49-56
measure: The Decisional Conflict Scale (DCS)
timeFrame: Day 49-56
Other outcomes:
measure: To Explore the Effects of Intervention Assignment on Clinical Trial Participation.
timeFrame: Day 49-56
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Honolulu
country: United States
facility: Hawaii MU-NCORP
state: Hawaii
city: Decatur
country: United States
facility: Heartland NCORP
state: Illinois
city: Prairie Village
country: United States
facility: Kansas City Clinical Oncology Program
state: Kansas
city: New Orleans
country: United States
facility: Gulf South MU-NCORP
state: Louisiana
city: Grand Rapids
country: United States
facility: Cancer Research Consortium of West Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Metro MN NCORP
state: Minnesota
city: Las Vegas
country: United States
facility: Nevada Cancer Research Foundation NCORP
state: Nevada
city: Las Vegas
country: United States
facility: Nevada NCORP
state: Nevada
city: Rochester
country: United States
facility: URCC / University of Rochester NCORP Research Base
state: New York
city: Winston-Salem
country: United States
facility: Southeast Clinical Oncology Research Consortium
state: North Carolina
city: Columbus
country: United States
facility: Columbus NCORP
state: Ohio
city: Dayton
country: United States
facility: Dayton Community Oncology Program
state: Ohio
city: Danville
country: United States
facility: Geisinger Cancer Institute NCORP
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Health System Cancer Instutite/Greenville NCORP
state: South Carolina
city: Marshfield
country: United States
facility: Wisconsin NCORP
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora NCORP
state: Wisconsin
Study officials:
affiliation: University of Rochester
name: Paul Jacobsen
role: PRINCIPAL_INVESTIGATOR
References: