Symptom Burden in Patients With Cancer- and Treatment-Related Skin Problems

Stopped early

Conditions studied: Skin Cancer

In brief

Objectives: The objective of this study is to develop a valid and reliable measure of the symptom burden experienced by patients with cancer experiencing disease-related skin problems and to delineate this burden over time. The Primary Aim is to develop and validate an M.D. Anderson Symptom Inventory (MDASI) module (the MDASI-Derm), compliant with FDA standards for patient-reported outcomes (PROs), to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients with cancer-related skin problems. We hypothesize that the MDASI-Derm will be valid and reliable for measuring the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients with cancer-related skin problems. The Secondary Aims are: 1. to develop a detailed description of the severity and interference with daily activities of symptoms experienced by patients with cancer-related skin problems; 2. to assess the impact of symptom severity on standard function and quality of life (QOL) measures including both quantitative (Eastern Cooperative Oncology Group \[ECOG\] Performance Status, single-item QOL, and Skindex-16 scales) and qualitative measures (patient interviews); 3. to evaluate the MDASI-Derm as an estimate of functional status and QOL in patients with cancer-related skin problems; 4. to identify common clusters of symptoms and symptom patterns occurring over multiple measurement time points in patients with cancer-related skin problems; 5. to define the qualitative symptom experience of patients with cancer-related skin problems; 6. to explore the feasibility of the Interactive Voice Response (IVR) system in measuring symptom severity and interference with daily activities over time in patients with cancer-related skin problems.

Key facts

Study ID

NCT01193036

Run by

M.D. Anderson Cancer Center

People needed

11

Starts

2010-08-01

Expected to finish

2013-12-01

Last updated by the study team

2015-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• Ability to read and speak English
• Receiving treatment and/or follow up at M. D. Anderson Cancer Center
• Residing where IVR service is available (Validation part of study only)
• Rating of skin problem at its worse in the last 24-hours of at least 1 on a 0 to 10 scale where 0 is no skin problem and 10 is the skin problem as bad as can be imagined
• Written consent to participate

You may not qualify if…

• Medical condition (impaired speech that would preclude taking part in a 30 minute interview, deafness that would impair the ability to use the IVR system) or impaired performance status that would preclude participation in the study
• Diagnosis of active psychosis or severe cognitive impairment as determined by physician
• Active treatment (systemic drug therapy or radiation therapy) for a second malignancy

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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