NCT02054715

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

Evaluation of Psychoeducation for Cancer Patients Eligible for Clinical Trials

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 418 (actual)
• Sponsor: Gary Morrow · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
BEHAVIORAL	print educational intervention	print educational intervention
BEHAVIORAL	multimedia psychoeducational intervention	multimedia psychoeducational intervention

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-08-31
• Completion: 2016-11-01
• First posted: 2014-02-04
• Last updated: 2021-01-27
• Results posted: 2017-08-11

Locations

18 sites across 1 country: United States