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Completed

NCT Number: NCT02054715

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

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Key information

Conditions

Malignant Neoplasm Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Diego State University, San Diego, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Print educational intervention

Behavioral

print educational intervention

Other names: intervention, educational

Multimedia Psychoeducational Intervention

Behavioral

multimedia psychoeducational intervention

Other names: intervention, educational

Primary outcomes

  1. Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale

    Time frame: 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 outcomes

  1. The Decision Regret Scale (DRS)

    Time frame: 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.

  2. The Decisional Conflict Scale (DCS)

    Time frame: 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.

Other outcomes

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

    Time frame: Day 49-56

    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.

Sponsors and collaborators

Lead sponsor

Gary Morrow

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Evaluation of Psychoeducation for Cancer Patients Eligible for Clinical Trials

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 4, 2014
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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