Cutaneous LymphomaNCT04670874
Quality of Life in Cutaneous Lymphoma Patients Using the Skindex29
An observational study of Cutaneous Lymphoma, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Lymphoma
- What is being tested?
- Quality-of-Life Assessment and Questionnaire Administration
- How many people
- 1,250 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2023to 24 Jan 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with presumed or confirmed diagnosis of CL who present to the Multidisciplinary CL Clinic at City of Hope
Who may be able to join
- Agreement to participate in the research study
- Presumed or confirmed diagnosis of CL
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Christiane Querfeld, 626-218-9018, cquerfeld@coh.org
Christiane Querfeld
About this study
Official title: Assessment of Quality of Life in Cutaneous Lymphoma Patients Using the Skindex29
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- 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.
- Conditions
- Cutaneous Lymphoma
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete quality of life questionnaire
Questionnaire AdministrationOther
Complete quality of life questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At completion of questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start17 Aug 2023
- Primary completion24 Jan 2034 (estimated)
- Study completion24 Jan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous LymphomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christiane Querfeld, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670874
- Sponsor's protocol ID
- 22364
- Other IDs
- NCI-2020-11058, 22364, P30CA033572
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2020
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Quality of Life in Cutaneous Lymphoma Patients Using the Skindex29
- ClinicalTrials.gov ID
- NCT04670874
- Acronym / sponsor ID
- 22364
- Conditions
- Cutaneous Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 24 Jan 2034 (estimated)
- Study completion
- 24 Jan 2034 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (quality of life questionnaire) | – | Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients complete quality of life questionnaires over 10-20 minutes about symptoms, emotions, and functioning related to diagnosis of cutaneous lymphoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with presumed or confirmed diagnosis of CL who present to the Multidisciplinary CL Clinic at City of Hope
Key inclusion criteria (2 listed)
- Agreement to participate in the research study
- Presumed or confirmed diagnosis of CL
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete quality of life questionnaire | Other | Observational (quality of life questionnaire) |
| Questionnaire AdministrationComplete quality of life questionnaire | Other | Observational (quality of life questionnaire) |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christiane Querfeld principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Lymphoma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skindex-29 domain (symptom, function, and emotion) scores (time frame: At completion of questionnaire). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.