NCT00750009

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
583

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

4.7 years

First QC Date

September 9, 2008

Last Update Submit

July 23, 2020

Conditions

Brain and Central Nervous System TumorsChronic Myeloproliferative DisordersLeukemiaLymphomaLymphoproliferative DisorderMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificaccelerated phase chronic myelogenous leukemiaacute undifferentiated leukemiaadult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult 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 negativeblastic phase chronic myelogenous leukemiachildhood acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionchildhood chronic myelogenous leukemiachronic myelomonocytic leukemiachronic phase chronic myelogenous leukemiajuvenile myelomonocytic leukemiamast cell leukemiameningeal chronic myelogenous leukemiaprogressive hairy cell leukemia, initial treatmentprolymphocytic leukemiarecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarecurrent adult T-cell leukemia/lymphomarecurrent childhood acute lymphoblastic leukemiarecurrent childhood acute myeloid leukemiarefractory chronic lymphocytic leukemiarefractory hairy cell leukemiarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiastage 0 chronic lymphocytic leukemiastage I adult T-cell leukemia/lymphomastage I chronic lymphocytic leukemiastage II adult T-cell leukemia/lymphomastage II chronic lymphocytic leukemiastage III adult T-cell leukemia/lymphomastage III chronic lymphocytic leukemiastage IV adult T-cell leukemia/lymphomastage IV chronic lymphocytic leukemiaT-cell large granular lymphocyte leukemiauntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemiauntreated childhood acute lymphoblastic leukemiauntreated childhood acute myeloid leukemia and other myeloid malignanciesuntreated hairy cell leukemiaAIDS-related diffuse large cell lymphomaAIDS-related diffuse mixed cell lymphomaAIDS-related diffuse small cleaved cell lymphomaAIDS-related immunoblastic large cell lymphomaAIDS-related lymphoblastic lymphomaAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomaAIDS-related small noncleaved cell lymphomaHIV-associated Hodgkin lymphomarecurrent adult Hodgkin lymphomarecurrent/refractory childhood Hodgkin lymphomastage I adult Hodgkin lymphomastage I childhood Hodgkin lymphomastage II adult Hodgkin lymphomastage II childhood Hodgkin lymphomastage III adult Hodgkin lymphomastage III childhood Hodgkin lymphomastage IV adult Hodgkin lymphomastage IV childhood Hodgkin lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomacutaneous B-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomastage I cutaneous T-cell non-Hodgkin lymphomastage II cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent mycosis fungoides/Sezary syndromestage I mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromeadult grade III lymphomatoid granulomatosisadult nasal type extranodal NK/T-cell lymphomaWaldenstrom macroglobulinemiaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomacontiguous stage II adult Burkitt lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II adult immunoblastic large cell lymphomacontiguous stage II adult lymphoblastic lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II mantle cell lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomastage I adult Burkitt lymphomastage I adult diffuse large cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse small cleaved cell lymphomastage I adult immunoblastic large cell lymphomastage I adult lymphoblastic lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage I mantle cell lymphomastage I marginal zone lymphomastage I small lymphocytic lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomastage I childhood large cell lymphomastage I childhood lymphoblastic lymphomastage I childhood small noncleaved cell lymphomastage II childhood large cell lymphomastage II childhood lymphoblastic lymphomastage II childhood small noncleaved cell lymphomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III childhood large cell lymphomastage III childhood lymphoblastic lymphomastage III childhood small noncleaved cell lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III small lymphocytic lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV childhood large cell lymphomastage IV childhood lymphoblastic lymphomastage IV childhood small noncleaved cell lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV small lymphocytic lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult grade III lymphomatoid granulomatosisrecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent childhood grade III lymphomatoid granulomatosisrecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood small noncleaved cell lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaBurkitt lymphomachildhood diffuse large cell lymphomachildhood grade III lymphomatoid granulomatosischildhood immunoblastic large cell lymphomachildhood nasal type extranodal NK/T-cell lymphomaintraocular lymphomaprimary central nervous system non-Hodgkin lymphomaprimary central nervous system Hodgkin lymphomapost-transplant lymphoproliferative disorderchronic eosinophilic leukemiachronic neutrophilic leukemiaprimary myelofibrosisessential thrombocythemiapolycythemia veraextramedullary plasmacytomaisolated plasmacytoma of bonestage I multiple myelomastage II multiple myelomastage III multiple myelomaprimary systemic amyloidosisrefractory multiple myelomade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesmyelodysplastic/myeloproliferative neoplasm, unclassifiablechildhood myelodysplastic syndromesrecurrent childhood anaplastic large cell lymphomastage I childhood anaplastic large cell lymphomastage II childhood anaplastic large cell lymphomastage III childhood anaplastic large cell lymphomastage IV childhood anaplastic large cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • Improvement in preparation for consideration of clinical trials

    after pts.complete all survey measures

Secondary Outcomes (5)

  • 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

Study Arms (2)

Arm I (PRE-ACT)

EXPERIMENTAL

Patients receive tailored feedback and video content to address clinical trial barriers following baseline assessment.

Other: educational intervention

Arm II (control)

ACTIVE COMPARATOR

Patients receive generic clinical trials educational feedback taken from NCI publications following baseline assessment.

Other: educational intervention

Interventions

educational interventionOTHER

Patients receive a tailored intervention or generic information

Arm I (PRE-ACT)Arm II (control)

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Related Publications (2)

  • Meropol NJ, Wong YN, Albrecht T, Manne S, Miller SM, Flamm AL, Benson AB 3rd, Buzaglo J, Collins M, Egleston B, Fleisher L, Katz M, Kinzy TG, Liu TM, Margevicius S, Miller DM, Poole D, Roach N, Ross E, Schluchter MD. Randomized Trial of a Web-Based Intervention to Address Barriers to Clinical Trials. J Clin Oncol. 2016 Feb 10;34(5):469-78. doi: 10.1200/JCO.2015.63.2257. Epub 2015 Dec 23.

    PMID: 26700123DERIVED

  • Wong YN, Schluchter MD, Albrecht TL, Benson AB 3rd, Buzaglo J, Collins M, Flamm AL, Fleisher L, Katz M, Kinzy TG, Liu TM, Manne S, Margevicius S, Miller DM, Miller SM, Poole D, Raivitch S, Roach N, Ross E, Meropol NJ. Financial Concerns About Participation in Clinical Trials Among Patients With Cancer. J Clin Oncol. 2016 Feb 10;34(5):479-87. doi: 10.1200/JCO.2015.63.2463. Epub 2015 Dec 23.

    PMID: 26700120DERIVED

MeSH Terms

Conditions

Central Nervous System NeoplasmsMyeloproliferative DisordersLeukemiaLymphomaLymphoproliferative DisordersMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesLeukemia, Myeloid, Accelerated PhaseLeukemia, Biphenotypic, AcuteCongenital AbnormalitiesLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Chronic-PhaseLeukemia, Myelomonocytic, JuvenileLeukemia, Mast-CellLeukemia, ProlymphocyticPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcutePrecursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellLeukemia, Large Granular LymphocyticHodgkin DiseaseRecurrenceLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeLymphoma, Extranodal NK-T-CellWaldenstrom MacroglobulinemiaLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticLymphoma, FollicularLymphoma, Mantle-CellDendritic Cell Sarcoma, InterdigitatingIntraocular LymphomaPdgfra-Associated Chronic Eosinophilic LeukemiaLeukemia, Neutrophilic, ChronicPrimary MyelofibrosisThrombocythemia, EssentialPolycythemia VeraImmunoglobulin Light-chain Amyloidosis

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMastocytosis, SystemicMastocytosisMast Cell Activation DisordersLeukemia, B-CellLeukemia, T-CellLymphoma, T-CellLymphadenopathyLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsHistiocytic Disorders, MalignantHistiocytosisEye NeoplasmsBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersBone Marrow NeoplasmsHematologic NeoplasmsAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Neal J. Meropol, MD

    Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2008

First Posted

September 10, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 27, 2020

Record last verified: 2020-07

Locations

US(4)