NCT02370446

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

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

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

February 18, 2015

Last Update Submit

January 10, 2017

Conditions

Lymphoma

Keywords

Medication Log15-008

Outcome Measures

Primary Outcomes (1)

  • 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)

    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 Outcomes (1)

  • changes in quality of life

    1 year

Study Arms (2)

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.

Other: personalized medication logBehavioral: questionnairesBehavioral: 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.

Other: standard of careBehavioral: questionnaires

Interventions

personalized medication logOTHER
patient gets personalized medication log
standard of careOTHER
patient gets standard of care
questionnairesBEHAVIORAL
patient gets personalized medication logpatient gets standard of care
Cognitive InterviewBEHAVIORAL
patient gets personalized medication log

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Documented major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Lymphoma

Interventions

Standard of CareSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Officials

  • Kimberly Anselmi, RN

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2015

First Posted

February 25, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 11, 2017

Record last verified: 2017-01

Locations

US(1)