N/A
Completed N=418
Multimedia Psychoeducation or Print Education in Preparing Cancer Patients for Decision Making About Clinical Trials
Malignant Neoplasm
Source: ClinicalTrials.gov NCT02054715 ↗
Enrolled (actual)
418
Serious AEs
1.7%
Results posted
Aug 2017
Primary outcomePrimary: Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale — 71.3; 71.2 percentage of PDMS (0 - 100) — p=0.9621
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale |
71.3; 71.2 | 0.9621 |
| SECONDARY The Decision Regret Scale (DRS) |
18.1; 18.3 | 0.9065 |
| SECONDARY The Decisional Conflict Scale (DCS) |
18.0; 17.9 | 0.9709 |
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
Data sourced from ClinicalTrials.gov (NCT02054715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.