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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.
Primary Outcome
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.
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 |
Why NCT01193036 stopped before completion
NCT01193036 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 11 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Part 1: Interview + Questionnaires is the first listed.
NCT01193036 does not publish any study locations in the registry export this page uses.
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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