Clinical trial NCT04670874: Quality of Life in Cutaneous Lymphoma Patients Using the Skindex29
Official title: Assessment of Quality of Life in Cutaneous Lymphoma Patients Using the Skindex29
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cutaneous Lymphoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-12-17
Enrollment: 1250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with presumed or confirmed diagnosis of CL who present to the Multidisciplinary CL Clinic at City of Hope

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.

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.

Eligibility criteria: Inclusion Criteria:

* Agreement to participate in the research study
* Presumed or confirmed diagnosis of CL

Primary outcomes:
measure: Skindex-29 domain (symptom, function, and emotion) scores
timeFrame: At completion of questionnaire
measure: Burden of pruritus
timeFrame: At completion of questionnaire
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Christiane Querfeld
role: PRINCIPAL_INVESTIGATOR
References: