Quality of Life in Cutaneous Lymphoma Patients Using the Skindex29

Sponsor
City of Hope Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04670874
Collaborator
National Cancer Institute (NCI) (NIH)
1,250
1
3
413.6

Study Details

Study Description

Brief Summary

This study assesses the quality of life in patients with cutaneous lymphoma diagnosis as it relates to their personal, clinical, and therapeutic information using the Skindex29 questionnaire and also assesses patients' understanding of their diagnosis and need for resources related to their care. Cutaneous lymphomas are a rare type of blood cancers (non-Hodgkin lymphoma) that present in the skin. The information gained from this study, may help researchers improve quality of life in cutaneous lymphoma patients.

Condition or Disease Intervention/Treatment Phase
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVES:
  1. 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.

  2. To prospectively evaluate the burden of pruritus in patients with CL via use of 10-point pruritus scale and compare to QoL.

  3. 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.

  4. To track changes in QoL and burden of pruritus as they relate to therapeutic strategies used to manage disease, including social work involvement.

  5. 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.

  6. 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 Design

Study Type:
Observational
Anticipated Enrollment :
1250 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessment of Quality of Life in Cutaneous Lymphoma Patients Using the Skindex29
Anticipated Study Start Date :
Oct 15, 2022
Anticipated Primary Completion Date :
Jan 15, 2023
Anticipated Study Completion Date :
Jan 15, 2023

Arms and Interventions

Arm 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.

Other: Quality-of-Life Assessment
Complete quality of life questionnaire
Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Complete quality of life questionnaire

    Outcome Measures

    Primary Outcome Measures

    1. Skindex-29 domain (symptom, function, and emotion) scores [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.

    2. Burden of pruritus [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Agreement to participate in the research study

    • Presumed or confirmed diagnosis of CL

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Christiane Querfeld, City of Hope Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT04670874
    Other Study ID Numbers:
    • 19200
    • NCI-2020-11058
    • 19200
    • P30CA033572
    First Posted:
    Dec 17, 2020
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 25, 2022