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NCT01193036 · ClinicalTrials.gov registry record
Symptom Burden in Patients With Cancer- and Treatment-Related Skin Problems
A clinical trial, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- 11
- Enrollment target
NCT01193036: Clinical Trial study, sponsored by M.D. Anderson Cancer Center.
NCT01193036 is a clinical trial that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 11 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01193036 was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- 11 participants
- Enrollment target
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.
Interventions
- BEHAVIORAL Part 1: Interview + Questionnaires
- BEHAVIORAL Part 2: Multiple Questionnaires
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2010-08 |
| Est. Completion | 2013-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01193036
The ClinicalTrials.gov registry entry for NCT01193036 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Part 1: Interview + Questionnaires is the first listed.
NCT01193036 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01193036 about?
NCT01193036 is a clinical study titled "Symptom Burden in Patients With Cancer- and Treatment-Related Skin Problems". 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 Invent...
What is the current status of trial NCT01193036?
This trial is currently terminated. The enrollment target is 11 participants. The study started on 2010-08. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01193036?
The interventions under investigation include: Part 1: Interview + Questionnaires (BEHAVIORAL), Part 2: Multiple Questionnaires (BEHAVIORAL).
Who is sponsoring clinical trial NCT01193036?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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