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

NCT01193036 | Terminated

• 1 other identifier: 2010-0551
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.to evaluate the MDASI-Derm as an estimate of functional status and QOL in patients with cancer-related skin problems;
4. 4.to identify common clusters of symptoms and symptom patterns occurring over multiple measurement time points in patients with cancer-related skin problems;
5. 5.to define the qualitative symptom experience of patients with cancer-related skin problems;
6. 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

Skin Cancer

Keywords

Psychosocial; Skin Problems; Supportive Care; Melanoma; Questionnaire

Outcome Measures

Primary Outcomes (1)

• Severity of Multiple Symptoms/Impact of Symptoms on Daily Functioning

  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.

  1 year

Study Arms (2)

Interview

Behavioral: Part 1: Interview + Questionnaires

Symptom Inventory Assessment

Behavioral: Part 2: Multiple Questionnaires

Interventions

Part 1: Interview + Questionnaires BEHAVIORAL

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

Interview

Part 2: Multiple Questionnaires BEHAVIORAL

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

Symptom Inventory Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MD Anderson Hospital and the Melanoma and Skin Center

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Skin Neoplasms; Melanoma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Loretta A. Williams, PhD, MSN

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: September 1, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 8, 2015

Record last verified: 2015-01

Locations

US (1)