NCT04670874

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,250

participants targeted

Target at P75+ for all trials

Timeline
94mo left

Started Aug 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress26%
Aug 2023Jan 2034

First Submitted

Initial submission to the registry

December 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
2.7 years until next milestone

Study Start

First participant enrolled

August 17, 2023

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2034

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

10.4 years

First QC Date

December 10, 2020

Last Update Submit

January 27, 2026

Conditions

Cutaneous Lymphoma

Outcome Measures

Primary Outcomes (2)

  • Skindex-29 domain (symptom, function, and emotion) scores

    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

    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

Study Arms (1)

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 AssessmentOther: Questionnaire Administration

Interventions

Quality-of-Life AssessmentOTHER

Complete quality of life questionnaire

Also known as: Quality of Life Assessment
Observational (quality of life questionnaire)
Questionnaire AdministrationOTHER

Complete quality of life questionnaire

Observational (quality of life questionnaire)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with presumed or confirmed diagnosis of CL who present to the Multidisciplinary CL Clinic at City of Hope

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Christiane Querfeld

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 10, 2020

First Posted

December 17, 2020

Study Start

August 17, 2023

Primary Completion (Estimated)

January 24, 2034

Study Completion (Estimated)

January 24, 2034

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

US(1)