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OpenTrials
Completed

NCT Number: NCT01269645

Facts and Attitudes About 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.

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Key information

Conditions

Cancer Neoplasm Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hartford Hospital, Hartford, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Are under the age of 18
  • Do not speak and read standard English
  • Are unable to provide informed consent

Treatment and study plan

Clinical Trial educational materials

Behavioral

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?

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Pfizer

Registry information

Official study title

Evaluating Educational Materials About Cancer Clinical Trials

Acronym: FACT

Important dates

Study start
2009
Primary completion
2011
Study completion
2014
First posted
Jan 4, 2011
Registry last updated
Jun 8, 2016

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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