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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Behavioral: print educational intervention; Behavioral: multimedia psychoeducational intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 418
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92182
      • San Diego State University
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Hawaii MU-NCORP
  • Illinois
    • Decatur, Illinois, United States, 62526
      • Heartland NCORP
  • Kansas
    • Prairie Village, Kansas, United States, 66208
      • Kansas City Clinical Oncology Program
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Gulf South MU-NCORP
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Cancer Research Consortium of West Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55426
      • Metro MN NCORP
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Nevada Cancer Research Foundation NCORP
    • Las Vegas, Nevada, United States, 89106
      • Nevada NCORP
  • New York
    • Rochester, New York, United States, 14642
      • URCC / University of Rochester NCORP Research Base
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27104
      • Southeast Clinical Oncology Research Consortium
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Columbus NCORP
    • Dayton, Ohio, United States, 45420
      • Dayton Community Oncology Program
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Cancer Institute NCORP
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Greenville Health System Cancer Instutite/Greenville NCORP
  • Wisconsin
    • Marshfield, Wisconsin, United States, 54449
      • Wisconsin NCORP
    • Milwaukee, Wisconsin, United States, 53226
      • Aurora NCORP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (print educational); 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; print educational intervention; Other Names: intervention, educational
Experimental: Arm II (multimedia psychoeducational); 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; multimedia psychoeducational intervention; Other Names: intervention, educational

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Explore the Effects of Intervention Assignment on Clinical Trial Participation.	Given the ethical perspective that patients have a right to make autonomous decisions about clinical trial participation, no hypothesis is offered about the effect of intervention assignment on clinical trial participation rates. To conduct the exploratory analysis regarding the effects of intervention assignment on clinical trial participation, data for all patients offered participation in a therapeutic clinical trial will be entered into a 2 (Intervention: MP or PE) x 2 (Clinical Trial Participation: Yes or No/Still Deciding) contingency table and analyzed using either a Fisher exact test or chi-square test as appropriate.	Day 49-56

Collaborators and Investigators

• Sponsor: Gary Morrow
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Paul Jacobsen, University of Rochester

Publications and helpful links

Helpful Links

• Description: Clinical trial summary from the National Cancer Institute's PDQ® database

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): August 31, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: January 31, 2014
• First Submitted That Met QC Criteria: January 31, 2014
• First Posted (Estimate): February 4, 2014

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: URCC12107 (Other Identifier: University of Rochester); U10CA037420 (U.S. NIH Grant/Contract); NCI-2013-02237 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); URCC-12107 (Other Identifier: DCP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO