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

NCT02054715 | Completed Results DMC

• 4 other identifiers: URCC12107NCI-2013-02237URCC-12107U10CA037420
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The Decision Regret Scale (DRS)

  Day 49-56

• The Decisional Conflict Scale (DCS)

  Day 49-56

Other Outcomes (1)

• To Explore the Effects of Intervention Assignment on Clinical Trial Participation.

  Day 49-56

Study Arms (2)

Arm I (print educational)

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.

Behavioral: print educational intervention

Arm II (multimedia psychoeducational)

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.

Behavioral: multimedia psychoeducational intervention

Interventions

print educational intervention BEHAVIORAL

print educational intervention

Also known as: intervention, educational

Arm I (print educational)

multimedia psychoeducational intervention BEHAVIORAL

multimedia psychoeducational intervention

Also known as: intervention, educational

Arm II (multimedia psychoeducational)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gary Morrow: lead
• National Cancer Institute (NCI): collaborator

Study Sites (18)

San Diego State University

San Diego, California, 92182, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Hawaii MU-NCORP

Honolulu, Hawaii, 96813, United States

Location

Heartland NCORP

Decatur, Illinois, 62526, United States

Location

Kansas City Clinical Oncology Program

Prairie Village, Kansas, 66208, United States

Location

Gulf South MU-NCORP

New Orleans, Louisiana, 70112, United States

Location

Cancer Research Consortium of West Michigan

Grand Rapids, Michigan, 49503, United States

Location

Metro MN NCORP

Minneapolis, Minnesota, 55426, United States

Location

Nevada Cancer Research Foundation NCORP

Las Vegas, Nevada, 89106, United States

Location

Nevada NCORP

Las Vegas, Nevada, 89106, United States

Location

URCC / University of Rochester NCORP Research Base

Rochester, New York, 14642, United States

Location

Southeast Clinical Oncology Research Consortium

Winston-Salem, North Carolina, 27104, United States

Location

Columbus NCORP

Columbus, Ohio, 43215, United States

Location

Dayton Community Oncology Program

Dayton, Ohio, 45420, United States

Location

Geisinger Cancer Institute NCORP

Danville, Pennsylvania, 17822, United States

Location

Greenville Health System Cancer Instutite/Greenville NCORP

Greenville, South Carolina, 29615, United States

Location

Wisconsin NCORP

Marshfield, Wisconsin, 54449, United States

Location

Aurora NCORP

Milwaukee, Wisconsin, 53226, United States

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Gary R. Morrow, PhD, MS; Deans Professor of Oncology
• Organization: University of Rochester Medical Center

Gary_Morrow@urmc.rochester.edu

585-275-9961

Study Officials

• Paul Jacobsen

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 4, 2014
• Study Start: May 1, 2014
• Primary Completion: August 31, 2016
• Study Completion: November 1, 2016
• Last Updated: January 27, 2021
• Results First Posted: August 11, 2017

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)