Trial Title:
Quality of Life (QoL) Assessment in Cancer Patients and Survivors With Dermatologic Conditions Using Dermatologic QoL Instruments
NCT ID:
NCT02296450
Condition:
Cancer
Dermatologic Conditions
Conditions: Official terms:
Skin Diseases
Disease
Conditions: Keywords:
Quality of Life (QoL)
Assessment
14-236
Patients and Survivors
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
Quality of Life (QoL) Assessment
Description:
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)
Arm group label:
Quality of Life (QoL) Assessment
Other name:
MELASQOL (Melasma QoL Questionnaire), MQ (Madarosis Questionnaire), CHIMES (The Children's International Muscositis Evaluation Scale), SDM-Q-9, WoSSAC, VF - 14, VFQ-25
Other name:
Scalpdex, Face-Q Skin Cancer, PRO-CTCAE Cutaneous IP, Traditional Decisional Conflict Scale
Other name:
ONYCHO (Nail-specific QoL questionnaire)
Other name:
FACT Lym (Functional Assessment of Cancer Therapy Lymphoma)
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
3 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
Basking Ridge
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erica Lee, MD
Phone:
646-888-6015
Facility:
Name:
Memorial Sloan Kettering Westchester
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erica Lee, MD
Phone:
646-888-6015
Facility:
Name:
Memorial Sloan Kettering Suffolk- Hauppauge
Address:
City:
Hauppauge
Zip:
11788
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erica Lee, MD
Phone:
646-888-6015
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erica Lee, MD
Phone:
646-888-6015
Contact backup:
Last name:
Shamir Geller, MD
Email:
gellers@mskcc.org
Investigator:
Last name:
Erica Lee, MD
Email:
Principal Investigator
Start date:
November 18, 2014
Completion date:
November 2024
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Collaborator:
Agency:
Comprehensive Cancer Centre The Netherlands
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02296450
https://www.mskcc.org/
