NCT00750009CompletedPhase 3
Preparatory Aid to Improve Decision Making About Cancer Clinical Trials (PRE-ACT)
Case Comprehensive Cancer Center4 sites in 1 country583 target enrollmentStarted: April 1, 2008Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 583
- Locations
- 4
- Primary Endpoint
- Improvement in preparation for consideration of clinical trials
Study Overview
Brief Summary
RATIONALE: Providing information that is tailored to answer patients' questions about clinical trials may help patients with cancer decide to enroll in a clinical trial. It is not known whether providing personalized information is more effective than basic information in helping patients make decisions about clinical trials.
PURPOSE: This randomized phase III trial is studying personalized information to see how well it works compared with basic information in helping patients make decisions about participating in a clinical trial.
Detailed Description
OBJECTIVES:
Primary
- To improve preparation for consideration of clinical trials by providing tailored information to address barriers related to knowledge, goals and values, and beliefs and expectancies before their physician visit in patients with advanced metastatic or early stage cancer.
Secondary
- To develop and pilot test a tailored interactive preparatory aid (PRE-ACT) to promote informed cancer treatment decision making by addressing barriers to considering clinical trials as a treatment option.
- To evaluate the efficacy of PRE-ACT in improving preparation for considering participation in clinical trials by conducting a randomized clinical trial to compare PRE-ACT vs generic clinical trial information with text (control condition).
- To investigate relevant background and psychosocial variables that are associated with preparedness, barriers, and treatment outcomes.
- To investigate the impact of PRE-ACT on patient decisional conflict, satisfaction with information received, satisfaction with discussion about clinical trials with the physician, satisfaction with the treatment decision, clinical trials discussion, clinical trials participation, and quality of informed consent.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following:
- •Advanced (metastatic) disease
- •Early stage (i.e., appropriate for adjuvant therapy) disease
- •Scheduled for first outpatient consultation with a medical oncologist at the Clinical Centers
- •PATIENT CHARACTERISTICS:
- •Able to read and verbally communicate in English
- •Patients who choose to complete the intervention at home rather than at the Clinical Center before their visit must have high-speed (i.e., DSL or cable) Internet access
- •PRIOR CONCURRENT THERAPY:
- •Not specified
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I (PRE-ACT)
Experimental
Patients receive tailored feedback and video content to address clinical trial barriers following baseline assessment.
Intervention: educational intervention (Other)
Arm II (control)
Active Comparator
Patients receive generic clinical trials educational feedback taken from NCI publications following baseline assessment.
Intervention: educational intervention (Other)
Outcomes
Primary Outcomes
Improvement in preparation for consideration of clinical trials
Time Frame: after pts.complete all survey measures
Secondary Outcomes
- Development and pilot testing of a tailored interactive preparatory aid (PRE-ACT)(after pts.complete all survey measures)
- Efficacy of PRE-ACT(after pts.complete all survey measures)
- Comparison of PRE-ACT and genomic clinical trial information with text(after pts.complete all survey measures)
- Relevant background and psychosocial variables that are associated with preparedness, barriers, and treatment outcomes(after pts.complete all survey measures)
- Impact of PRE-ACT on patient(after pts.complete all survey measures)
Investigators
Study Sites (4)
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