Quality of Life (QoL) Assessment in Cancer Patients and Survivors With Dermatologic Conditions Using Dermatologic QoL Instruments

December 11, 2023 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to see how skin conditions that are related to different kinds of cancer or cancer treatments affect a patient's overall well-being. Skin conditions are common in cancer patients and survivors. Sometimes, the skin condition is directly related to the cancer. Other times, these conditions are a side effect of cancer treatment. Patients in the study will be asked to fill out at least one questionnaire about how they feel about their skin condition. If the patient needs to be treated for their skin condition, they will be asked to complete the same questionnaire when they return for a follow-up visit. The investigators hope the study will improve our understanding of how cancer patients feel about their skin conditions. They also hope this study helps them learn how to improve the way we treat skin conditions in cancer patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1025

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Erica Lee, MD
  • Phone Number: 646-888-6015

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Erica Lee, MD
          • Phone Number: 646-888-6015
    • New York
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Contact:
          • Erica Lee, MD
          • Phone Number: 646-888-6015
      • Hauppauge, New York, United States, 11788
        • Recruiting
        • Memorial Sloan Kettering Suffolk- Hauppauge
        • Contact:
          • Erica Lee, MD
          • Phone Number: 646-888-6015
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Erica Lee, MD
          • Phone Number: 646-888-6015
        • Contact:
        • Principal Investigator:
          • Erica Lee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Cancer patients and survivors who present to MSKCC's Dermatology clinics in Manhattan, Basking Ridge, Haupaugge or West Harrison may be approached to participate in this study.

Description

Inclusion Criteria:

  • Cancer patients and survivors with a pre-existing dermatologic condition related to their underlying disease or completed/ongoing therapy for cancer, who present for assessment/management of their skin condition.
  • Male or female patients at least 3 years and older
  • NOTE: Informed Consent guidelines will be followed for minors
  • First grade adult family members, spouses, and caregivers of patients with a Grade 2 or 3 or higher dermatologic condition related to their primary cancer or cancer treatment able to provide written informed consent

Exclusion Criteria:

  • Cognitive or psychiatric deficit resulting in an inability to provide written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Quality of Life (QoL) Assessment
Patients involved in this study will have a wide range of dermatologic conditions for which they will be assessed and managed by the treating physician. An appropriate QoL instrument will be administered at the initial visit, and if applicable, at subsequent follow-up visit(s). Treatment of the dermatologic condition will be at physician's discretion based on the patient's presenting symptoms and is not an intervention itself within this study.
Behavioral: Quality of Life (QoL) Assessment
Per physician's discretion, the patient (or, if applicable, patient's family member/ spouse/ caregiver for FDLQI) will complete one or more of the following dermatology-specific QoL instruments: Skindex-16, Skindex-29 DLQI (Dermatology Life Quality Index), FDLQI (Family DLQI) - for patient's family member/spouse/caregiver ONLY, CDLQI (Children's DLQI;Cartoon version) - for patient's under the age of 18 ONLY-written, CDLQI (Children's DLQI; Cartoon version) - for patients under the age of 18 ONLY - cartoon version, FACT-G (Functional Assessment of Cancer Thearpy-General), FACT-Melanoma (Functional Assessment of Cancer Therapy-Melanoma), SCI (Skin Cancer Index) FACT-EGFRI-18 (Functional Assessment of Cancer Therapy-Epidermal Growth Factor Receptor Inhibitor-18), HFS-14 (Hand-Foot Syndrome) OMWQ (Oral Mucositis Weekly Questionnaire), ESTEEM, Hairdex , Skindex-29 modified for hair loss, Itchy QoL,CADS (Chemotherapy-induced alopecia distress scale)
Other Names:
  • MELASQOL (Melasma QoL Questionnaire), MQ (Madarosis Questionnaire), CHIMES (The Children's International Muscositis Evaluation Scale), SDM-Q-9, WoSSAC, VF - 14, VFQ-25
  • Scalpdex, Face-Q Skin Cancer, PRO-CTCAE Cutaneous IP, Traditional Decisional Conflict Scale
  • ONYCHO (Nail-specific QoL questionnaire)
  • FACT Lym (Functional Assessment of Cancer Therapy Lymphoma)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (QoL) questionnaire
Time Frame: 5 years
in cancer patients and survivors with dermatologic conditions. This is a nontherapeutic and nondiagnostic protocol to obtain quality of life assessments from cancer patients and survivors who have dermatologic conditions, whether related to cancer therapies, or directly related to the primary cancer diagnosis. Data will be collected by using one or more dermatology-specific QoL instruments based on the underlying skin condition/s.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Comprehensive Cancer Centre The Netherlands

Investigators

  • Principal Investigator: Erica Lee, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2014

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimated)

November 20, 2014

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-236

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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