Clinical trial · Interventional

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)

NCT00750009CI-TRIAL-00046183completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (9)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Brain and Central Nervous System Tumors	—	UNRESOLVED	—
Chronic Myeloproliferative Disorders	Myeloproliferative Neoplasm	ALIAS	0.90
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90
Lymphoproliferative Disorder	—	UNRESOLVED	—
Multiple Myeloma and Plasma Cell Neoplasm	—	UNRESOLVED	—
Myelodysplastic/Myeloproliferative Neoplasms	Myelodysplastic/Myeloproliferative Neoplasm	CURATED_BROADER	0.80
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS	0.90
Unspecified Adult Solid Tumor, Protocol Specific	Adult Solid Neoplasm	ALIAS

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
educational intervention	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Arm I (PRE-ACT)
description
Patients receive tailored feedback and video content to address clinical trial barriers following baseline assessment.
interventionNames
1. Other: educational intervention
type
ACTIVE_COMPARATOR
label
Arm II (control)
description
Patients receive generic clinical trials educational feedback taken from NCI publications following baseline assessment.
interventionNames
1. Other: educational intervention

Primary outcomes (1)

measure
Improvement in preparation for consideration of clinical trials
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 120 Years

Show eligibility criteria text

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

References

Publications (2)

DERIVEDMeropol 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 26700123
DERIVEDWong 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 26700120

Registry

Dates and enrollment