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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00750009
First received: September 9, 2008
Last updated: August 20, 2013
Last verified: August 2013

September 9, 2008
August 20, 2013
April 2008
December 2012   (final data collection date for primary outcome measure)
Improvement in preparation for consideration of clinical trials [ Time Frame: after pts.complete all survey measures ] [ Designated as safety issue: No ]
Improvement in preparation for consideration of clinical trials [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00750009 on ClinicalTrials.gov Archive Site
  • Development and pilot testing of a tailored interactive preparatory aid (PRE-ACT) [ Time Frame: after pts.complete all survey measures ] [ Designated as safety issue: No ]
  • Efficacy of PRE-ACT [ Time Frame: after pts.complete all survey measures ] [ Designated as safety issue: No ]
  • Comparison of PRE-ACT and genomic clinical trial information with text [ Time Frame: after pts.complete all survey measures ] [ Designated as safety issue: No ]
  • Relevant background and psychosocial variables that are associated with preparedness, barriers, and treatment outcomes [ Time Frame: after pts.complete all survey measures ] [ Designated as safety issue: No ]
  • Impact of PRE-ACT on patient [ Time Frame: after pts.complete all survey measures ] [ Designated as safety issue: No ]
    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)
  • Development and pilot testing of a tailored interactive preparatory aid (PRE-ACT) [ Designated as safety issue: No ]
  • Efficacy of PRE-ACT [ Designated as safety issue: No ]
  • Comparison of PRE-ACT and genomic clinical trial information with text [ Designated as safety issue: No ]
  • Relevant background and psychosocial variables that are associated with preparedness, barriers, and treatment outcomes [ Designated as safety issue: No ]
  • 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 ... [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Personalized Information or Basic Information in Helping Patients Make Decisions About Participating in a Clinical Trial
Preparatory Aid to Improve Decision Making About Cancer Clinical Trials (PRE-ACT)

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.

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.
  • Arm II (control): Patients receive generic clinical trials educational feedback taken from NCI publications following baseline assessment.

All patients complete a baseline assessment to assess demographics, personal characteristics, preparedness, and barriers to clinical trials. All patients also undergo a post-intervention assessment and complete a survey to measure preparedness for consideration of clinical trials, and impact of the intervention on clinical trials barriers. A brief patient post-consultation assessment is completed by patients within two weeks of the physician consultation to determine whether clinical trials were discussed, patient satisfaction with discussion about clinical trials, treatment options, treatment selection, decisional conflict, and satisfaction with treatment decision. Quality of informed consent is also assessed for patients participating in a clinical trial and completing the consent process during their initial physician consultation. Each patient's physician completes a brief Physician Post-Consultation Assessment to define cancer stage, treatment goal, and to determine whether clinical trials were offered and accepted and if not, why not. For patients who have not made a treatment decision after consultation, a brief follow-up phone survey or medical chart review is used to identify the patient's treatment choice.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
  • Brain and Central Nervous System Tumors
  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Unspecified Adult Solid Tumor, Protocol Specific
Other: educational intervention
Patients receive a tailored intervention or generic information
  • Experimental: Arm I (PRE-ACT)
    Patients receive tailored feedback and video content to address clinical trial barriers following baseline assessment.
    Intervention: Other: educational intervention
  • Active Comparator: Arm II (control)
    Patients receive generic clinical trials educational feedback taken from NCI publications following baseline assessment.
    Intervention: Other: educational intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
583
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00750009
CASE18Z09, R01CA127655, P30CA006927, FCCC-08808
Yes
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Neal J. Meropol, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP