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

NCT01193036 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2015-01-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Part 1: Interview + Questionnaires

Questionnaires to be completed immediately after interview, which will take approximately 15 minutes.

BEHAVIORAL

Part 2: Multiple Questionnaires

Questionnaires to be repeated about every 2 weeks for 1 year.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Loretta A. Williams, PhD, MSN · UT MD Anderson Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01193036 on ClinicalTrials.gov