Facts and Attitudes About Clinical Trials (FACT)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Paul Jacobsen, H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01269645
First received: December 22, 2010
Last updated: September 11, 2012
Last verified: August 2011
  Purpose

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.


Condition Intervention
Cancer
Neoplasm
Behavioral: Clinical Trial educational materials

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluating Educational Materials About Cancer Clinical Trials

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • Impact of information on participation in clinical trials [ Time Frame: Medical record review (6 weeks after completion of baseline survey) ] [ Designated as safety issue: No ]
    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.


Enrollment: 473
Study Start Date: July 2009
Study Completion Date: August 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Clinical Trials: Are They Right for You?

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269645

Locations
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Pfizer
Investigators
Principal Investigator: Paul B Jacobsen, PhD H. Lee Moffitt Cancer Center and Research Institute
  More Information

No publications provided

Responsible Party: Paul Jacobsen, Division Chief, Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01269645     History of Changes
Other Study ID Numbers: MCC# 15820
Study First Received: December 22, 2010
Last Updated: September 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Cancer
Clinical trials

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 20, 2014