Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00750009
Recruitment Status : Completed
First Posted : September 10, 2008
Last Update Posted : July 27, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.


Condition or disease Intervention/treatment Phase
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 Phase 3

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.

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 583 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Preparatory Aid to Improve Decision Making About Cancer Clinical Trials (PRE-ACT)
Study Start Date : April 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Diffuse Large B-Cell Lymphoma B-cell Lymphoma Lymphosarcoma Follicular Lymphoma Childhood Acute Lymphoblastic Leukemia Myeloid Leukemia Chronic Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Multiple Myeloma Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Marginal Zone Lymphoma Hairy Cell Leukemia Waldenstrom Macroglobulinemia Primary Myelofibrosis Hodgkin Lymphoma Post-transplant Lymphoproliferative Disease Extranodal Nasal NK/T Cell Lymphoma Polycythemia Vera Essential Thrombocythemia Primary Central Nervous System Lymphoma Burkitt Lymphoma Mycosis Fungoides Sezary Syndrome Chronic Myeloproliferative Disorders Anaplastic Large Cell Lymphoma AL Amyloidosis Myelodysplastic/myeloproliferative Disease Cutaneous T-cell Lymphoma Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Adult T-cell Leukemia/lymphoma Plasmacytoma Leukemia, T-cell, Chronic Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Chronic Neutrophilic Leukemia Aggressive NK Cell Leukemia Lymphomatoid Granulomatosis T-cell Large Granular Lymphocyte Leukemia

Arm Intervention/treatment
Experimental: Arm I (PRE-ACT)
Patients receive tailored feedback and video content to address clinical trial barriers following baseline assessment.
Other: educational intervention
Patients receive a tailored intervention or generic information

Active Comparator: Arm II (control)
Patients receive generic clinical trials educational feedback taken from NCI publications following baseline assessment.
Other: educational intervention
Patients receive a tailored intervention or generic information




Primary Outcome Measures :
  1. Improvement in preparation for consideration of clinical trials [ Time Frame: after pts.complete all survey measures ]

Secondary Outcome Measures :
  1. Development and pilot testing of a tailored interactive preparatory aid (PRE-ACT) [ Time Frame: after pts.complete all survey measures ]
  2. Efficacy of PRE-ACT [ Time Frame: after pts.complete all survey measures ]
  3. Comparison of PRE-ACT and genomic clinical trial information with text [ Time Frame: after pts.complete all survey measures ]
  4. Relevant background and psychosocial variables that are associated with preparedness, barriers, and treatment outcomes [ Time Frame: after pts.complete all survey measures ]
  5. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750009


Locations
Layout table for location information
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Neal J. Meropol, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00750009    
Other Study ID Numbers: CASE18Z09
R01CA127655 ( U.S. NIH Grant/Contract )
FCCC-08808 ( Other Identifier: Fox Chase Cancer Center )
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Keywords provided by Case Comprehensive Cancer Center:
unspecified adult solid tumor, protocol specific
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
atypical chronic myeloid leukemia, BCR-ABL1 negative
blastic phase chronic myelogenous leukemia
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
juvenile myelomonocytic leukemia
mast cell leukemia
meningeal chronic myelogenous leukemia
progressive hairy cell leukemia, initial treatment
prolymphocytic leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent adult T-cell leukemia/lymphoma
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
refractory chronic lymphocytic leukemia
refractory hairy cell leukemia
relapsing chronic myelogenous leukemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Neoplasms
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Preleukemia
Nervous System Neoplasms
Central Nervous System Neoplasms
Myelodysplastic Syndromes
Myeloproliferative Disorders
Lymphoproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Disease
Syndrome
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Neoplasms by Site
Nervous System Diseases