Symptom Burden in Patients With Cancer- and Treatment-Related Skin Problems
|ClinicalTrials.gov Identifier: NCT01193036|
Recruitment Status : Terminated (Low accrual.)
First Posted : September 1, 2010
Last Update Posted : January 8, 2015
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:
- to develop a detailed description of the severity and interference with daily activities of symptoms experienced by patients with cancer-related skin problems;
- 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);
- to evaluate the MDASI-Derm as an estimate of functional status and QOL in patients with cancer-related skin problems;
- to identify common clusters of symptoms and symptom patterns occurring over multiple measurement time points in patients with cancer-related skin problems;
- to define the qualitative symptom experience of patients with cancer-related skin problems;
- 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.
|Condition or disease||Intervention/treatment|
|Skin Cancer||Behavioral: Part 1: Interview + Questionnaires Behavioral: Part 2: Multiple Questionnaires|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||Symptom Burden in Patients With Cancer- and Treatment-Related Skin Problems|
|Study Start Date :||August 2010|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
Behavioral: Part 1: Interview + Questionnaires
Questionnaires to be completed immediately after interview, which will take approximately 15 minutes.
|Symptom Inventory Assessment||
Behavioral: Part 2: Multiple Questionnaires
Questionnaires to be repeated about every 2 weeks for 1 year.
- Severity of Multiple Symptoms/Impact of Symptoms on Daily Functioning [ Time Frame: 1 year ]MDASI-Derm measure of severity + impact of 13 cancer-related core symptoms that cause most interference with daily activities; Severity of symptoms rated (with amount of interference with daily living) on scales from 0 to 10, with 0 meaning no symptom or interference and 10 meaning as severe or complete interference.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193036
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Loretta A. Williams, PhD, MSN||UT MD Anderson Cancer Center|