Facts and Attitudes About Clinical Trials (FACT)

June 6, 2016 updated by: H. Lee Moffitt Cancer Center and Research Institute

Evaluating Educational Materials About Cancer Clinical Trials

The primary objective of this project is to examine the impact of providing cancer patients with audiovisual information about clinical trials on attitudes towards clinical trial participation. It is hypothesized that patients provided these materials will have more favorable attitudes toward clinical trial participation compared to patients not provided these materials.

Participants will be randomized to either: (1) an intervention condition in which they will be asked to view a short video and read an accompanying brochure about clinical trials developed by the investigative team; or (2) a control condition in which they will be asked to read the National Cancer Institute's brochure entitled "Taking Part in Cancer Treatment Research Studies." Self-report data will be collected at two timepoints: 1) in person following study enrollment, but before receipt of material related to intervention assignment (baseline/Time 1), and 2) by telephone interview between 7 and 28 days following study enrollment (follow-up/Time 2). In addition, data will also be collected from medical records six weeks after study enrollment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

471

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida, Gainesville
      • Lakeland, Florida, United States, 33805
        • Center for Cancer Care & Research/Watson
      • Ocala, Florida, United States, 34474
        • Ocala Oncology Center
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute
      • Titusville, Florida, United States, 32796
        • Space Coast Medical Associates
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  1. Be diagnosed with cancer
  2. Have not been asked previously to participate in a clinical trial of a treatment for cancer
  3. Be scheduled for a visit with a medical oncologist at the time of recruitment

Exclusion Criteria:

  1. Are under the age of 18
  2. Do not speak and read standard English
  3. Are unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care
Usual care and provision of National Cancer Institute brochure "Taking Part in Cancer Treatment Research Studies." Participants will be asked to read this brochure after completion of the baseline surveys and will be given a copy to take home with them.
Behavioral: Clinical Trial educational materials
Usual care and (1) a 10-minute clinical trials educational video; and (2) a 12-page educational booklet to accompany the educational video. Content includes basic information about clinical trials and patient testimonials about the value and benefits of participating in clinical trials. The video also addresses common misperceptions about clinical trials using patient and physician testimonials. After watching the video, participants will be provided a copy of the video for home viewing, along with the educational booklet to be reviewed at home.
Other Names:
  • Clinical Trials: Are They Right for You?
Experimental: Clinical Trial educational materials
Usual care and (1) a 10-minute clinical trials educational video; and (2) a 12-page educational booklet to accompany the educational video. Content includes basic information about clinical trials and patient testimonials about the value and benefits of participating in clinical trials. The video also addresses common misperceptions about clinical trials using patient and physician testimonials. After watching the video, participants will be provided a copy of the video for home viewing, along with the educational booklet to be reviewed at home.
Behavioral: Clinical Trial educational materials
Usual care and (1) a 10-minute clinical trials educational video; and (2) a 12-page educational booklet to accompany the educational video. Content includes basic information about clinical trials and patient testimonials about the value and benefits of participating in clinical trials. The video also addresses common misperceptions about clinical trials using patient and physician testimonials. After watching the video, participants will be provided a copy of the video for home viewing, along with the educational booklet to be reviewed at home.
Other Names:
  • Clinical Trials: Are They Right for You?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to follow-up in attitudes towards clinical trial participation
Time Frame: Baseline (before first med onc visit; after first med onc visit; or before second med onc visit) and Follow-up (7-28 days after baseline)
The primary objective of this project is to examine the impact of providing cancer patients with audiovisual information about clinical trials on attitudes towards clinical trial participation. It is hypothesized that patients provided these materials will have more favorable attitudes toward clinical trial participation compared to patients not provided these materials.
Baseline (before first med onc visit; after first med onc visit; or before second med onc visit) and Follow-up (7-28 days after baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of information on knowledge, self-efficacy, receptivity, and likelihood of participating
Time Frame: Baseline (before first med onc visit; after first med onc visit; or before second med onc visit) and Follow-up (7-28 days after baseline)
The secondary objectives are to examine the impact of audiovisual information about clinical trials on knowledge, self-efficacy, receptivity, and likelihood of participating in a clinical trial. It is hypothesized that patients provided audiovisual materials will be more knowledgeable about clinical trials, will believe themselves to be more capable of participating in a clinical trial, will be more receptive to learning more about a clinical trial, and will report greater likelihood of participating in a clinical trial if asked compared to patients not provided these materials.
Baseline (before first med onc visit; after first med onc visit; or before second med onc visit) and Follow-up (7-28 days after baseline)
Impact of information on participation in clinical trials
Time Frame: Medical record review (6 weeks after completion of baseline survey)
The tertiary objective is to explore the impact of providing cancer patients with audiovisual information about clinical trials on actual participation in clinical trials. Since this aim is exploratory, no hypothesis is offered.
Medical record review (6 weeks after completion of baseline survey)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Pfizer

Investigators

  • Principal Investigator: Paul B Jacobsen, PhD, H. Lee Moffitt Cancer Center and Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

December 22, 2010

First Submitted That Met QC Criteria

January 3, 2011

First Posted (Estimate)

January 4, 2011

Study Record Updates

Last Update Posted (Estimate)

June 8, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MCC-15820

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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