NCT01490983

Brief Summary

This study is being conducted in a population of patients with chronic phase Chronic Myeloid Leukemia (CML) to learn more about how patients follow prescribed regimens for taking oral cancer drugs.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

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, 2009

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 13, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 13, 2018

Status Verified

April 1, 2016

Enrollment Period

5.5 years

First QC Date

December 8, 2011

Last Update Submit

August 9, 2018

Conditions

Chronic Myeloid Leukemia

Keywords

Chronic Myeloid LeukemiaChronic Phase CML

Outcome Measures

Primary Outcomes (1)

  • eMedonline will be used to measure non-compliance in taking oral drug regimens.

    Patients are stratified to one of two groups: Group 1 is patients on Gleevec or Tasigna who have been on drug less than 6 months; Group 2 is patients on Gleevec or Tasigna who have been on drug for equal to or more than 6 months. Group 1 is then divided into 2 groups: one using eMedonline for 3 months and the other not using eMedonline for 3 months. A crossover survey and pill counts will be done at the 3 month timepoint and then the groups will switch their access status to eMedonline.

    at 6 months, non-compliance will be measured in each arm of study

Study Arms (2)

eMedonline access

EXPERIMENTAL

patients will have access to eMedonline access for 3 months

Behavioral: eMedonline access

no access to eMedonline

OTHER

patients will be followed for 3 months with no access to eMedonline

Behavioral: no access to eMedonline

Interventions

no access to eMedonlineBEHAVIORAL

patients will be followed for 3 months but will not use eMedonline

Also known as: Telemonitoring system, e-diary, electronic diary
no access to eMedonline
eMedonline accessBEHAVIORAL

patients will be given access to eMedonline use for 3 months

Also known as: Telemonitoring system, e-diary, electronic diary
eMedonline access

Eligibility Criteria

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

You may qualify if:

  • Patients 18 years of age or older.
  • Pathologically documented diagnosis of Chronic Phase CML (Ph+) in whom treating physician has determined that treatment with imatinib or nilotinib is appropriate
  • Patients currently receiving Gleevec (imatinib) 300-600 mg daily or Tasigna (nilotinib) 300-400 mg twice daily
  • ECOG Performance status 0, 1, or 2
  • Adequate end organ function, defined as:
  • Total bilirubin \< 1.5 xULN
  • SGOT and SGPT \<2.5 x ULN
  • Creatinine \< 1.5 x ULN
  • ANC \> 1.5
  • Platelets \> 100,000
  • Female patients of child bearing potential must have a negative urine or serum pregnancy test at screening.
  • Patient is able to read and speak English
  • Patient is willing and able to use a cell phone
  • Written, voluntary informed consent

You may not qualify if:

  • Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UNC Healthcare

Chapel Hill, North Carolina, 27599, United States

Location

Rex Cancer Center

Raleigh, North Carolina, 27607, United States

Location

Rex Cancer Center - Wakefield

Raleigh, North Carolina, 27614, United States

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Chronic-Phase

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Robert Wehbie, MD

    Rex Cancer Center - Wakefield

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2011

First Posted

December 13, 2011

Study Start

April 1, 2009

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

August 13, 2018

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

US(3)