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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02296450
Recruitment Status : Recruiting
First Posted : November 20, 2014
Last Update Posted : December 27, 2019
Sponsor:
Collaborator:
Comprehensive Cancer Centre The Netherlands
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Cancer Dermatologic Conditions Behavioral: Quality of Life (QoL) Assessment

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quality of Life (QoL) Assessment in Cancer Patients and Survivors With Dermatologic Conditions Using Dermatologic QoL Instruments
Actual Study Start Date : November 18, 2014
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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 who are able to speak/read English and provide written informed consent
  • 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 who are able to speak/read English and provide written informed consent may complete the FDLQI questionnaire

Exclusion Criteria:

  • Inability to read and/or speak English
  • Cognitive or psychiatric deficit resulting in an inability to provide written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296450


Contacts
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Contact: Mario Lacouture, MD 646-888-6014
Contact: Erica Lee, MD 646-888-6015

Locations
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United States, New Jersey
Memoral Sloan Kettering Cancer Center Recruiting
Basking Ridge, New Jersey, United States
Contact: Mario Lacouture, MD    646-888-6014      
United States, New York
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Mario Lacouture, MD    646-888-6014      
Memorial Sloan Kettering Cancer Center Hauppauge Recruiting
Hauppauge, New York, United States, 11788
Contact: Mario Lacouture, MD    646-888-6014      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Mario Lacouture, MD    646-888-6014      
Contact: Erica Lee, MD    646-888-6015      
Principal Investigator: Mario Lacouture, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Comprehensive Cancer Centre The Netherlands
Investigators
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Principal Investigator: Mario Lacouture, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02296450    
Other Study ID Numbers: 14-236
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: December 27, 2019
Last Verified: December 2019
Keywords provided by Memorial Sloan Kettering Cancer Center:
Quality of Life (QoL)
Assessment
14-236
Patients and Survivors
Additional relevant MeSH terms:
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Skin Diseases
Disease
Pathologic Processes