Multimedia Psychoeducation or Print Education in Preparing Cancer Patients for Decision Making About Clinical Trials

Gary Morrow

Status: Completed

Conditions: Malignant Neoplasm

Treatments: Behavioral: print educational intervention; Behavioral: multimedia psychoeducational intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02054715

NCI-2013-02237 (Registry Identifier)

U10CA037420 (U.S. NIH Grant/Contract)

URCC-12107 (Other Identifier)

URCC12107 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 418 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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418 participants in 2 patient groups

Arm I (print educational)

Experimental group

Description:

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.

Treatment:

Behavioral: print educational intervention

Arm II (multimedia psychoeducational)

Experimental group

Description:

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.

Treatment:

Behavioral: multimedia psychoeducational intervention