Overview

This trial is active, not recruiting.

Condition malignant neoplasm
Treatments educational intervention, questionnaire administration
Sponsor University of Rochester
Collaborator National Cancer Institute (NCI)
Start date May 2014
End date August 2016
Trial size 418 participants
Trial identifier NCT02054715, NCI-2013-02237, U10CA037420, URCC-12107, URCC12107

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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.
educational intervention intervention, educational
Undergo print educational intervention
questionnaire administration
Ancillary studies
(Experimental)
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.
educational intervention intervention, educational
Undergo multimedia psychoeducational intervention
questionnaire administration
Ancillary studies

Primary Outcomes

Measure
Preparedness for decision making about clinical trial participation, measured using scores from the Preparation for Decision Making Scale
time frame: Up to day 56

Secondary Outcomes

Measure
Quality of decision making based on decisional conflict and decisional regret measured using total scores on the decisional conflict scale
time frame: Up to day 56
Attitudes regarding clinical trial participation
time frame: Up to day 56
Self-efficacy regarding clinical trial participation
time frame: Up to day 56

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Evaluation of Psychoeducation for Cancer Patients Eligible for Clinical Trials
Principal investigator Paul Jacobsen
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Rochester.
Location data was received from the National Cancer Institute and was last updated in April 2016.