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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02296450
Collaborator
Comprehensive Cancer Centre The Netherlands (Other)
1,025
4
119.5
256.3
2.1

Study Details

Study Description

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 Phase
  • Behavioral: Quality of Life (QoL) Assessment

Study Design

Study Type:
Observational
Anticipated Enrollment :
1025 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 :
Nov 18, 2014
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm 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)
  • Outcome Measures

    Primary Outcome Measures

    1. Quality of Life (QoL) questionnaire [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memoral Sloan Kettering Cancer Center Basking Ridge New Jersey United States
    2 Memorial Sloan Kettering Westchester Harrison New York United States 10604
    3 Memorial Sloan Kettering Suffolk- Hauppauge Hauppauge New York United States 11788
    4 Memorial Sloan Kettering Cancer Center New York New York United States 10021

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center
    • Comprehensive Cancer Centre The Netherlands

    Investigators

    • Principal Investigator: Mario Lacouture, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02296450
    Other Study ID Numbers:
    • 14-236
    First Posted:
    Nov 20, 2014
    Last Update Posted:
    Jul 14, 2022
    Last Verified:
    Jul 1, 2022
    Keywords provided by Memorial Sloan Kettering Cancer Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 14, 2022