Clinical trial NCT01269645: Facts and Attitudes About Clinical Trials
Official title: Evaluating Educational Materials About Cancer Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Neoplasm
Keywords: Cancer
Clinical trials
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2011-01-04
Enrollment: 471
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to follow-up in attitudes towards clinical trial participation
timeFrame: 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:
measure: Impact of information on knowledge, self-efficacy, receptivity, and likelihood of participating
timeFrame: 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)
measure: Impact of information on participation in clinical trials
timeFrame: Medical record review (6 weeks after completion of baseline survey)
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida, Gainesville
state: Florida
city: Lakeland
country: United States
facility: Center for Cancer Care & Research/Watson
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Titusville
country: United States
facility: Space Coast Medical Associates
state: Florida
city: Billings
country: United States
facility: Billings Clinic
state: Montana
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Paul B Jacobsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: