Facts and Attitudes About Clinical Trials (FACT)

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Neoplasm; Cancer

Treatments: Behavioral: Clinical Trial educational materials

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01269645

MCC-15820

Details and patient eligibility

About

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.

Enrollment: 471 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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471 participants in 2 patient groups

Usual care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Clinical Trial educational materials

Clinical Trial educational materials

Experimental group

Description:

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.

Treatment:

Behavioral: Clinical Trial educational materials