Skin CancerNCT01193036
Symptom Burden in Patients With Cancer- and Treatment-Related Skin Problems
An observational study of Skin Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Part 1: Interview + Questionnaires and Part 2: Multiple Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MD Anderson Hospital and the Melanoma and Skin Center
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Part I:
Interview:
If you agree to take part in this study, while you are at the clinic for a visit, you will be interviewed about skin problems and other symptoms that you have had since you began experiencing skin problems. The interview should take about 30 minutes to complete.
Part I:
Questionnaires:
After the interview, you will be asked to answer a general symptom questionnaire, a quality-of-life questionnaire, a skin-specific questionnaire, and some demographic questions (such as your age and marital status). It should take about 15 minutes to complete all 4 questionnaires.
Part II:
Symptom Questionnaires:
If you agree to take part in this study, you will complete a questionnaire about skin problems and other symptoms you are having. This symptom questionnaire will ask you to rate how severe your skin problems and other symptoms are and how the skin problems and other symptoms affect the activities of your daily life. It should take about 5 minutes to complete. You will complete the questionnaire at a routine clinic visit every 2 weeks for 1 year. If you do not have a clinic visit every 2 weeks, you will be called by an automated phone system so you may complete the questionnaire at least 1 time every 2 weeks.
You can decide what time is most convenient for the automated phone system to call you. If you are not available when the automated system calls, it will call you again at a later time. You will be given a secure user name and identification number to use with the automated phone system. The study staff will teach you how to use the automated phone system.
Two (2) days after you begin the study, you will fill out the symptom questionnaire again. You will take home a paper copy of the questionnaire with you from the clinic with a pre-addressed, stamped envelope given to you by the research staff so you can return it. The research staff will also ask for your telephone number so that they may contact you and remind you to complete the questionnaire.
Quality-of-Life/Demographic Questionnaires:
At the first visit, you will also be asked some demographic questions (such as your age and employment status). Answering these questions should take about 1 minute. Some of these questions (such as employment status) will be repeated at regular clinic visits. You will not be asked to do this more often than every 3-5 weeks.
At the first visit and at regular clinic visits, you will also rate your overall quality-of-life. This should take about 1 minute to complete. You will not be asked to do this more often than every 3-5 weeks.
At the first visit and at regular clinic visits, you will be asked to complete a second questionnaire that asks specific questions about how problems with your skin affect the quality of your life. This should take about 5 minutes to complete. You will not be asked to do this more often than every 3-5 weeks.
Opinion Questionnaire:
If you are 1 of the first 20 participants enrolled in Part 2 of this study, you will be asked questions about your opinion of the symptom questionnaire after you have completed it for the first time. For example, you will be asked if the symptom questionnaire was easy to understand and complete, and if there were any other questions that should be included. The study staff will use your opinion to decide if changes should be made to the questionnaire or if important symptom questions are missing from the questionnaire. This questionnaire should take about 5 minutes to complete.
Part I:
Length of Study:
After you have completed the interview and questionnaires, your participation on this study will be over.
Part II:
Length of Study You will be on study for 1 year. You will be off study after you complete the last symptom questionnaire.
This is an investigational study. Up to 60 participants will take part in this study. Up to 20 will be enrolled in Part 1 of this study. Up to 40 participants will be enrolled in Part 2 of this study. All will be enrolled at MD Anderson.
- Conditions
- Skin Cancer
- Being tested
- Part 1: Interview + Questionnaires, Part 2: Multiple Questionnaires
- Keywords
- Psychosocial, Skin Problems, Supportive Care, Melanoma, Questionnaire
- Medical subject headings
- Skin Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part 1: Interview + QuestionnairesBehavioural
Questionnaires to be completed immediately after interview, which will take approximately 15 minutes.
Part 2: Multiple QuestionnairesBehavioural
Questionnaires to be repeated about every 2 weeks for 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Interview | Not described Receives: Behavioral: Part 1: Interview + Questionnaires | |
| Symptom Inventory Assessment | Not described Receives: Behavioral: Part 2: Multiple Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loretta A. Williams, PhD, MSN, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193036
- Sponsor's protocol ID
- 2010-0551
- Status last verified
- Jan 2015
- First submitted
- 30 Aug 2010
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Burden in Patients With Cancer- and Treatment-Related Skin Problems
- ClinicalTrials.gov ID
- NCT01193036
- Acronym / sponsor ID
- 2010-0551
- Conditions
- Skin Cancer
- Keywords
- Psychosocial, Skin Problems, Supportive Care, Melanoma, Questionnaire
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low accrual.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Part I:
Interview:
If you agree to take part in this study, while you are at the clinic for a visit, you will be interviewed about skin problems and other symptoms that you have had since you began experiencing skin problems. The interview should take about 30 minutes to complete.
Part I:
Questionnaires:
After the interview, you will be asked to answer a general symptom questionnaire, a quality-of-life questionnaire, a skin-specific questionnaire, and some demographic questions (such as your age and marital status). It should take about 15 minutes to complete all 4 questionnaires.
Part II:
Symptom Questionnaires:
If you agree to take part in this study, you will complete a questionnaire about skin problems and other symptoms you are having. This symptom questionnaire will ask you to rate how severe your skin problems and other symptoms are and how the skin problems and other symptoms affect the activities of your daily life. It should take about 5 minutes to complete. You will complete the questionnaire at a routine clinic visit every 2 weeks for 1 year. If you do not have a clinic visit every 2 weeks, you will be called by an automated phone system so you may complete the questionnaire at least 1 time every 2 weeks.
You can decide what time is most convenient for the automated phone system to call you. If you are not available when the automated system calls, it will call you again at a later time. You will be given a secure user name and identification number to use with the automated phone system. The study staff will teach you how to use the automated phone system.
Two (2) days after you begin the study, you will fill out the symptom questionnaire again. You will take home a paper copy of the questionnaire with you from the clinic with a pre-addressed, stamped envelope given to you by the research staff so you can return it. The research staff will also ask for your telephone number so that they may contact you and remind you to complete the questionnaire.
Quality-of-Life/Demographic Questionnaires:
At the first visit, you will also be asked some demographic questions (such as your age and employment status). Answering these questions should take about 1 minute. Some of these questions (such as employment status) will be repeated at regular clinic visits. You will not be asked to do this more often than every 3-5 weeks.
At the first visit and at regular clinic visits, you will also rate your overall quality-of-life. This should take about 1 minute to complete. You will not be asked to do this more often than every 3-5 weeks.
At the first visit and at regular clinic visits, you will be asked to complete a second questionnaire that asks specific questions about how problems with your skin affect the quality of your life. This should take about 5 minutes to complete. You will not be asked to do this more often than every 3-5 weeks.
Opinion Questionnaire:
If you are 1 of the first 20 participants enrolled in Part 2 of this study, you will be asked questions about your opinion of the symptom questionnaire after you have completed it for the first time. For example, you will be asked if the symptom questionnaire was easy to understand and complete, and if there were any other questions that should be included. The study staff will use your opinion to decide if changes should be made to the questionnaire or if important symptom questions are missing from the questionnaire. This questionnaire should take about 5 minutes to complete.
Part I:
Length of Study:
After you have completed the interview and questionnaires, your participation on this study will be over.
Part II:
Length of Study You will be on study for 1 year. You will be off study after you complete the last symptom questionnaire.
This is an investigational study. Up to 60 participants will take part in this study. Up to 20 will be enrolled in Part 1 of this study. Up to 40 participants will be enrolled in Part 2 of this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interview | – | Behavioral: Part 1: Interview + Questionnaires |
| Symptom Inventory Assessment | – | Behavioral: Part 2: Multiple Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MD Anderson Hospital and the Melanoma and Skin Center
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Part 1: Interview + QuestionnairesQuestionnaires to be completed immediately after interview, which will take approximately 15 minutes. | Behavioural | Interview |
| Part 2: Multiple QuestionnairesQuestionnaires to be repeated about every 2 weeks for 1 year. | Behavioural | Symptom Inventory Assessment |
Primary outcome
Severity of Multiple Symptoms/Impact of Symptoms on Daily Functioning
Time frame: 1 year
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.
Results and safety
The study was stopped early (reason given: Low accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loretta A. Williams, PhD, MSN principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low accrual.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Multiple Symptoms/Impact of Symptoms on Daily Functioning (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2015.