Clinical Trial: Personalized Information or Basic Information in Helping Patients Make Decisions About Participating in a Clinical Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Preparatory Aid to Improve Decision Making About Cancer Clinical Trials (PRE-ACT)

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 Summary:

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.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I (PRE-ACT): Patients receive tailored feedback and video content to address clinical trial barriers following baseline assessment.
• Development and pilot testing of a tailored interactive preparatory aid (PRE-ACT) [ Time Frame: after pts.complete all survey measures ]
• Efficacy of PRE-ACT [ Time Frame: after pts.complete all survey measures ]
• Comparison of PRE-ACT and genomic clinical trial information with text [ Time Frame: after pts.complete all survey measures ]
• Relevant background and psychosocial variables that are associated with preparedness, barriers, and treatment outcomes [ Time Frame: after pts.complete all survey measures ]
• Impact of PRE-ACT on patient [ Time Frame: after pts.complete all survey measures ]
  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. (Exploratory Aim)

Original Secondary Outcome:

• Development and pilot testing of a tailored interactive preparatory aid (PRE-ACT)
• Efficacy of PRE-ACT
• Comparison of PRE-ACT and genomic clinical trial information with text
• Relevant background and psychosocial variables that are associated with preparedness, barriers, and treatment outcomes
• Impact of PRE-ACT on patient decisional conflict, satisfaction with information received, satisfaction with discussion about clinical trials with physician, satisfaction with treatment decision, clinical trials discussion, clinical trials participati ...

Dates:
Date Received: September 9, 2008
Date Started: April 2008
Date Completion:
Last Updated: August 20, 2013
Last Verified: August 2013