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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Psychoeducation for Cancer Patients Eligible for Clinical Trials

Conditions
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Malignant Neoplasm

Intervention / Treatment
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* Behavioral: print educational intervention
* Behavioral: multimedia psychoeducational intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (print educational)<br>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. | Behavioral: print educational intervention<br>* print educational intervention<br>* Other names: intervention, educational;|
| Experimental: Arm II (multimedia psychoeducational)<br>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. | Behavioral: multimedia psychoeducational intervention<br>* multimedia psychoeducational intervention<br>* Other names: intervention, educational;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale | Preparation for Decision Making Scale (PDMS) is a valid and reliable 10-item self-report measure for which respondents rate the usefulness of materials they were provided in preparing them to communicate with their health care provider and make a health care decision. Each item is scored 1 to 5 where 1=Not at All, 2=A Little, 3=Somewhat, 4=Quite a Bit, 5=A Great Deal. Larger number is better. All 10 scores are summed, then divided by 10; The result - 1 is then multiplied by 25 and we have a range from 0 (less prepared) - 100 (most prepared). | Day 3 to 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Decision Regret Scale (DRS) | The Decision Regret Scale (DRS) is a five-item paper and pencil self-report measure that asks subjects to reflect on a particular decision and then rate each item on a Likert scale from 1 (strongly agree) to 5 (strongly disagree). A mean score for the DRS is calculated by reverse scoring the two negatively phrased items and dividing by five. The mean scores are converted to a score ranging from 0 to 100 by subtracting 1 and multiplying by 25 and higher scores represent increases in the severity of decision regret. Higher scores are worse. | Day 49-56 | 
| The Decisional Conflict Scale (DCS) | The Decisional Conflict Scale (DCS) is a valid and reliable 16-item self-report measure that assesses the extent to which respondents experience certainty, satisfaction, and confidence following a health care decision. In the present study, it will be keyed to the decision about therapeutic clinical trial participation. Instructions given to respondents include asking them to reflect on the decisions have just made or are about to make and to respond to statements in the DCS using a five-point Likert scale. Responses to each statement are scored from 1 (strongly agree) to 5 (strongly disagree), with negative statements having reverse scoring; thus high scores indicate higher decisional conflict. | Day 49-56 |