Facts and Attitudes About Clinical Trials

NCT01269645

Last updated date
Study Location
Hartford Hospital
Hartford, Connecticut, 06102, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cancer, Neoplasm
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Are under the age of 18


2. Do not speak and read standard English


3. Are unable to provide informed consent

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

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[email protected]

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Cancer, NeoplasmFacts and Attitudes About Clinical Trials
NCT01269645
  1. Hartford, Connecticut
  2. Gainesville, Florida
  3. Lakeland, Florida
  4. Ocala, Florida
  5. Tampa, Florida
  6. Titusville, Florida
  7. Billings, Montana
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Facts and Attitudes About Clinical Trials
Official Title  ICMJE Evaluating Educational Materials About Cancer Clinical Trials
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cancer
  • Neoplasm
Intervention  ICMJE 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?
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Clinical Trial educational materials
  • 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.
    Intervention: Behavioral: Clinical Trial educational materials
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2014)
471
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2011)
420
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01269645
Other Study ID Numbers  ICMJE MCC-15820
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor  ICMJE H. Lee Moffitt Cancer Center and Research Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Paul B Jacobsen, PhDH. Lee Moffitt Cancer Center and Research Institute
PRS Account H. Lee Moffitt Cancer Center and Research Institute
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP