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

This study has been terminated.
(No Funding)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01193036
First received: August 30, 2010
Last updated: December 16, 2013
Last verified: December 2013
  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:

  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.

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.


Enrollment: 11
Study Start Date: August 2010
Primary Completion Date: December 2013 (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:

  1. 18 years of age or older
  2. Ability to read and speak English
  3. Receiving treatment and/or follow up at M. D. Anderson Cancer Center
  4. Residing where IVR service is available (Validation part of study only)
  5. 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
  6. Written consent to participate

Exclusion Criteria:

  1. 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
  2. Diagnosis of active psychosis or severe cognitive impairment as determined by physician
  3. 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: December 16, 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 April 21, 2014