Facts and Attitudes About Clinical Trials

NCT01269645 | Completed

• 1 other identifier: MCC-15820
• Study Type: interventional
• Target: 471
• Locations: 1 country
• Sites: 7

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.

Conditions

Cancer; Neoplasm

Keywords

Cancer; Clinical trials

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Impact of information on knowledge, self-efficacy, receptivity, and likelihood of participating

  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)

• Impact of information on participation in clinical trials

  Medical record review (6 weeks after completion of baseline survey)

Study Arms (2)

Usual care

ACTIVE COMPARATOR

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

Clinical Trial educational materials

EXPERIMENTAL

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

Interventions

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.

Also known as: Clinical Trials: Are They Right for You?

Clinical Trial educational materials; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Pfizer: collaborator

Study Sites (7)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

University of Florida, Gainesville

Gainesville, Florida, 32610, United States

Location

Center for Cancer Care & Research/Watson

Lakeland, Florida, 33805, United States

Location

Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Space Coast Medical Associates

Titusville, Florida, 32796, United States

Location

Billings Clinic

Billings, Montana, 59101, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Paul B Jacobsen, PhD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: January 4, 2011
• Study Start: July 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: July 1, 2014
• Last Updated: June 8, 2016

Record last verified: 2016-06

Locations

US (7)