Facts and Attitudes About Clinical Trials

Cancer Clinical Trial

— FACT  

Official title:

Evaluating Educational Materials About Cancer Clinical Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269645
• Other study ID #: MCC-15820
• Status: Completed
• Phase: N/A
• First received: December 22, 2010
• Last updated: June 6, 2016
• Start date: July 2009
• Est. completion date: July 2014

Study information

• Verified date: June 2016
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 471
• Est. completion date: July 2014
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Neoplasm

Intervention

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.

Locations

Country	Name	City	State
United States	Billings Clinic	Billings	Montana
United States	University of Florida, Gainesville	Gainesville	Florida
United States	Hartford Hospital	Hartford	Connecticut
United States	Center for Cancer Care & Research/Watson	Lakeland	Florida
United States	Ocala Oncology Center	Ocala	Florida
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida
United States	Space Coast Medical Associates	Titusville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to follow-up in attitudes towards clinical trial participation	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)	No
Secondary	Impact of information on knowledge, self-efficacy, receptivity, and likelihood of participating	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)	No
Secondary	Impact of information on participation in clinical trials	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)	No