Quality of Life in Cutaneous Lymphoma Patients Using the Skindex29
Assessment of Quality of Life in Cutaneous Lymphoma Patients Using the Skindex29
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To prospectively assess quality of life (QoL) in adult patients with cutaneous lymphoma (CL) via use of a validated questionnaire (Skindex-29) and identify the psychosocial needs of our patient population.
II. To prospectively evaluate the burden of pruritus in patients with CL via use of 10-point pruritus scale and compare to QoL.
III. To evaluate QoL for any correlation with demographic and clinical information, specifically, age, gender, race/ethnicity, type of CL, stage of mycosis fungoides (MF)/Sezary syndrome (SS), treatment regimen, and social work involvement.
IV. To track changes in QoL and burden of pruritus as they relate to therapeutic strategies used to manage disease, including social work involvement.
V. To prospectively assess patients' knowledge and understanding of their cancer diagnosis, prognosis, and overall survival; and to track changes in their knowledge and understanding, and assess for any correlation to QoL.
VI. To prospectively evaluate our patients' need for resources, and our ability to meet those needs; and to assess for any correlation to demographic or clinical category, or QoL.
OUTLINE:
Patients complete quality of life questionnaires over 10-20 minutes about symptoms, emotions, and functioning related to diagnosis of cutaneous lymphoma.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- Recruiting
- City of Hope Medical Center
-
Contact:
- Christiane Querfeld
- Phone Number: 626-218-9018
- Email: cquerfeld@coh.org
-
Principal Investigator:
- Christiane Querfeld
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Agreement to participate in the research study
- Presumed or confirmed diagnosis of CL
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational (quality of life questionnaire)
Patients complete quality of life questionnaires over 10-20 minutes about symptoms, emotions, and functioning related to diagnosis of cutaneous lymphoma.
|
Complete quality of life questionnaire
Other Names:
Complete quality of life questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skindex-29 domain (symptom, function, and emotion) scores
Time Frame: At completion of questionnaire
|
Skindex-29 domain (symptom, function, and emotion) scores will be summarized by diagnosis group, demographics, disease characteristics, treatment/intervention, and disease response/clinical outcome.
Cross-sectional and longitudinal summary of the data will be performed.
Descriptive statistics for continuous data (mean, standard deviation, median, range, etc.) will be used to summarize quality of life.
Descriptive and summary statistics or continuous and categorical data (counts and percentages) will be used to summarize continuous or categorical demographics or other patient/disease characteristics respectively.
Graphical representation of the data will be used when helpful.
Descriptive statistics for categorical data will be used to assess patients' understanding of their cancer diagnosis and need for resources based on the survey.
|
At completion of questionnaire
|
|
Burden of pruritus
Time Frame: At completion of questionnaire
|
Burden of pruritus as measured by pruritus scale will be summarized by diagnosis group, demographics, disease characteristics, treatment/intervention, and disease response/clinical outcome.
Cross-sectional and longitudinal summary of the data will be performed.
Descriptive statistics for continuous data (mean, standard deviation, median, range, etc.) will be used to summarize pruritus score.
Descriptive and summary statistics or continuous and categorical data (counts and percentages) will be used to summarize continuous or categorical demographics or other patient/disease characteristics respectively.
Graphical representation of the data will be used when helpful.
Descriptive statistics for categorical data will be used to assess patients' understanding of their cancer diagnosis and need for resources based on the survey.
|
At completion of questionnaire
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christiane Querfeld, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22364 (Other Identifier: City of Hope Medical Center)
- P30CA033572 (U.S. NIH Grant/Contract)
- NCI-2020-11058 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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