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

Not Applicable

Completed

• Conditions: Malignant Neoplasm
• Interventions: Behavioral: print educational intervention; Behavioral: multimedia psychoeducational intervention

• Registration Number: NCT02054715
• Lead Sponsor: Gary Morrow

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.

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 Timeline

• Study First Submitted: 2014-01-31
• Study First Submitted QC: 2014-01-31
• Study First Posted: 2014-02-04
• Study Start: 2014-05-01
• Primary Completion: 2016-08-31
• Study Completion: 2016-11
• Results First Submitted: 2017-07-05
• Results First Submitted QC: 2017-07-05
• Results First Posted: 2017-08-11
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 418

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (print educational)	print educational intervention	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.
Arm II (multimedia psychoeducational)	multimedia psychoeducational intervention	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.

Primary Outcome Measures

Name	Time	Method
Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale	Day 3 to 7	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).

Secondary Outcome Measures

Name	Time	Method
The Decisional Conflict Scale (DCS)	Day 49-56	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.
The Decision Regret Scale (DRS)	Day 49-56	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.

Trial Locations

Locations (18)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

URCC / University of Rochester NCORP Research Base; 🇺🇸 Rochester, New York, United States

Dayton Community Oncology Program; 🇺🇸 Dayton, Ohio, United States

Southeast Clinical Oncology Research Consortium; 🇺🇸 Winston-Salem, North Carolina, United States

Aurora NCORP; 🇺🇸 Milwaukee, Wisconsin, United States

San Diego State University; 🇺🇸 San Diego, California, United States

Heartland NCORP; 🇺🇸 Decatur, Illinois, United States

Metro MN NCORP; 🇺🇸 Minneapolis, Minnesota, United States

Nevada NCORP; 🇺🇸 Las Vegas, Nevada, United States

Columbus NCORP; 🇺🇸 Columbus, Ohio, United States

Geisinger Cancer Institute NCORP; 🇺🇸 Danville, Pennsylvania, United States

Wisconsin NCORP; 🇺🇸 Marshfield, Wisconsin, United States

Hawaii MU-NCORP; 🇺🇸 Honolulu, Hawaii, United States

Kansas City Clinical Oncology Program; 🇺🇸 Prairie Village, Kansas, United States

Gulf South MU-NCORP; 🇺🇸 New Orleans, Louisiana, United States

Cancer Research Consortium of West Michigan; 🇺🇸 Grand Rapids, Michigan, United States

Nevada Cancer Research Foundation NCORP; 🇺🇸 Las Vegas, Nevada, United States

Greenville Health System Cancer Instutite/Greenville NCORP; 🇺🇸 Greenville, South Carolina, United States