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

Malignant Neoplasm Clinical Trial

Official title:

Evaluation of Psychoeducation for Cancer Patients Eligible for Clinical Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02054715
• Other study ID #: URCC12107
• Secondary ID: NCI-2013-02237UR
• Status: Completed
• Phase: N/A
• Start date: May 1, 2014
• Est. completion date: November 2016

Study information

• Verified date: January 2021
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: November 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Behavioral:
• print educational intervention
print educational intervention
• multimedia psychoeducational intervention
multimedia psychoeducational intervention

Locations

Country	Name	City	State
United States	Columbus NCORP	Columbus	Ohio
United States	Geisinger Cancer Institute NCORP	Danville	Pennsylvania
United States	Dayton Community Oncology Program	Dayton	Ohio
United States	Heartland NCORP	Decatur	Illinois
United States	Cancer Research Consortium of West Michigan	Grand Rapids	Michigan
United States	Greenville Health System Cancer Instutite/Greenville NCORP	Greenville	South Carolina
United States	Hawaii MU-NCORP	Honolulu	Hawaii
United States	Nevada Cancer Research Foundation NCORP	Las Vegas	Nevada
United States	Nevada NCORP	Las Vegas	Nevada
United States	Wisconsin NCORP	Marshfield	Wisconsin
United States	Aurora NCORP	Milwaukee	Wisconsin
United States	Metro MN NCORP	Minneapolis	Minnesota
United States	Gulf South MU-NCORP	New Orleans	Louisiana
United States	Kansas City Clinical Oncology Program	Prairie Village	Kansas
United States	URCC / University of Rochester NCORP Research Base	Rochester	New York
United States	San Diego State University	San Diego	California
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Southeast Clinical Oncology Research Consortium	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Gary Morrow	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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

External Links

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