Symptom Burden in Patients With Cancer- and Treatment-Related Skin Problems
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01193036
First received: August 30, 2010
Last updated: April 22, 2013
Last verified: April 2013
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Purpose
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:
- 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 | Intervention |
|---|---|
|
Skin Cancer |
Behavioral: Part 1: Interview + Questionnaires Behavioral: Part 2: Multiple Questionnaires |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Symptom Burden in Patients With Cancer- and Treatment-Related Skin Problems |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Severity of Multiple Symptoms/Impact of Symptoms on Daily Functioning [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2010 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Interview |
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
MD Anderson Hospital and the Melanoma and Skin Center
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193036
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Loretta A. Williams, PhD, MSN | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01193036 History of Changes |
| Other Study ID Numbers: | 2010-0551 |
| Study First Received: | August 30, 2010 |
| Last Updated: | April 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Psychosocial Skin Problems Supportive Care Melanoma Questionnaire |
Additional relevant MeSH terms:
|
Skin Neoplasms Neoplasms by Site Neoplasms Skin Diseases |
ClinicalTrials.gov processed this record on May 21, 2013