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

Intervention / Treatment

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

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

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
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.
Behavioral: questionnaires
Other: personalized medication log
Behavioral: Cognitive Interview
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.
Behavioral: questionnaires
Other: standard of care

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
as identified qualitatively through the process of cognitive interviewing and further measured with the satisfaction question on the Patient Satisfaction and Treatment Data Sheet
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in quality of life
Time Frame: 1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

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.

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