Testing a Personalize Medication Log for Patients With Lymphoma
January 10, 2017 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to see if using the MedLog is helpful to patients.
Since the investigators do not yet know if this MedLog is helpful, some patients will receive it and some will receive our standard of care.
The investigators want to know whether providing patients with this additional information is helpful and if having this additional information about their treatment schedule has an effect on their quality of life.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
5
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC).
Description
Inclusion Criteria:
- Diagnosis of lymphoma
- No prior treatment for lymphoma
- Scheduled to receive CHOP14 +/- Rituximab, CEOP 21, CHOPE or EPOCH +/- Rituximab
- Age 18 or older
- Able to speak and read English
Exclusion Criteria:
- Documented major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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patient gets personalized medication log
Patients in the intervention group will receive a personalized medication log that includes all treatment medications (IV and oral), days of treatment and medication specific information such as timing or diet restrictions.
The personalized medication log and patient education materials (fact cards) will be placed in a clear plastic envelope that the patient can carry with them throughout treatment.
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patient gets standard of care
Current MSKCC standards of professional nursing practice require the professional nurse to develop a plan of care that includes teaching the patient and support system the prescribed prescriptions / regimen and all doses, route, length of treatment, side effects and safety precautions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
patient satisfaction with medication log ( identified qualitatively through the process of cognitive interviewing and further measured with the satisfaction question on the Patient Satisfaction and Treatment Data Sheet)
Time Frame: 1 year
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as identified qualitatively through the process of cognitive interviewing and further measured with the satisfaction question on the Patient Satisfaction and Treatment Data Sheet
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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changes in quality of life
Time Frame: 1 year
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before and during therapy, as measured by PROMIS, Distress Thermometer and FACT scores, and to evaluate adherence with oral treatment medications, as measured by the MMAS-8.
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kimberly Anselmi, RN, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
February 18, 2015
First Submitted That Met QC Criteria
February 24, 2015
First Posted (Estimate)
February 25, 2015
Study Record Updates
Last Update Posted (Estimate)
January 11, 2017
Last Update Submitted That Met QC Criteria
January 10, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.