NCT02296450

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,025

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

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 Progress96%
Nov 2014Nov 2026

First Submitted

Initial submission to the registry

November 18, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

November 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

12 years

First QC Date

November 18, 2014

Last Update Submit

December 12, 2025

Conditions

Keywords

Quality of Life (QoL)Assessment14-236Patients and Survivors

Outcome Measures

Primary Outcomes (1)

  • Quality of Life (QoL) questionnaire

    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

Study Arms (1)

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

Interventions

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)

Also known as: 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)
Quality of Life (QoL) Assessment

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Memorial Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

RECRUITING

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Suffolk- Hauppauge

Hauppauge, New York, 11788, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

Quality of LifeRestraint, Physical

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthBehavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Erica Lee, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erica Lee, MD

CONTACT

Shamir Geller, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 20, 2014

Study Start

November 18, 2014

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations