Breast CancerNCT00535067
Neuropathic Pain in Survivors of Breast Cancer
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The objectives of this study are to: 1) describe the prevalence of neuropathic pain (NP) in breast cancer survivors and 2) to develop preliminary statistical risk models for predicting the risk for NP incorporating disease-related variables (e.g., stage of disease, location of tumor), treatment variables… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 239 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Nov 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: Breast Cancer survivors.
Who may be able to join
- Breast cancer patients who were participants in clinical trials (ID98-240; ID94-002) for taxanes during 1994-2001
- Alive and with current contact information
- Age ≥ 18 years. (This restriction is based on inclusion criteria for the clinical trials from which subjects will be recruited. All patients will be at least 18 years or older for this study.)
Who cannot join
- 1) None
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of this study are to: 1) describe the prevalence of neuropathic pain (NP) in breast cancer survivors and 2) to develop preliminary statistical risk models for predicting the risk for NP incorporating disease-related variables (e.g., stage of disease, location of tumor), treatment variables (chemotherapy, dose, duration; and other cancer therapy), clinical health status (e.g., comorbid conditions), and sociodemographic characteristics (e.g., age, sex, race).
Researchers will also gather data to answer the following secondary aims:
- To assess the impact of NP on quality of life.
- To assess the current management of NP in cancer (current medication, duration of such treatment, reasons for discontinuation) and the outcomes of this management.
Read the detailed description
You have already been contacted by phone about participating in this study. You have received study documents (this consent and the study questionnaires) because you said over the phone that you would like to participate in this study.
In this study you will be asked to complete questionnaires that will ask about any pain you may be experiencing and about the quality of your life. These questionnaires will also ask for demographic information (such as age, race, and sex) and about your health. It should take about 1 hour to complete all of the questionnaires. In addition to the questionnaires, you will also be asked questions about any medications you may currently be taking for pain. All of the information you include on the questionnaires will be kept confidential. There are no right or wrong answers to the questions. A postage-paid return envelope has been provided for you to return this consent and the questionnaires.
Researchers are interested in how pain is related to certain treatments and medical conditions. As part of this study, researchers will review your medical records to see what type of cancer treatment you received and whether you had any pain related to the treatment. They will also see if you had any non-cancer health conditions that may have affected pain and quality of life.
This survey is for research purposes only. Your healthcare provider will not be informed of your responses to this survey. If you are experiencing severe pain and/or other symptoms, please contact your healthcare provider. The study staff has also included a list of community resources that you may contact for different types of services.
Your participation in this study will be over once you mail back the consent and questionnaires.
This is an investigational study. Up to 635 individuals will be asked to take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Breast Cancer
- Being tested
- Questionnaire
- Keywords
- Breast Cancer, Questionnaire, Survey, Neuropathic Pain, Cancer Survivors, Quality of Life, QOL
- Medical subject headings
- Breast Neoplasms, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaires taking 60 minutes total to complete.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Survivors | Not described Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of neuropathic pain (NP) in breast cancer survivors
Assessment of neuropathic pain will be standardized using two validated tools for this purpose: the self report version of the LANSS pain score (S-LANSS) [Bennett 2001, Bennett et al 2004] and ID Pain (IDP) [Portenoy, et al, 2006]. The S-LANSS is a 7-item instrument that identifies pain of predominantly neuropathic origin. A score of 10 or more (out of a maximum of 24), regarded as a "positive" score, identifies neuropathic pain with a sensitivity, specificity and positive predictive value all of 80%. It has been found to be valid and reliable in both clinical and mail-survey settings [Bennett et al 2004]. The IDP is a 6-item scale that assesses the quality of pain, and has been well-validated [Portenoy, et al, 2006].
Measured: 3 Years
Secondary outcomes (1)
Study of how much pain, factors related to the pain, and how the pain affects life
Preliminary statistical risk models for predicting the risk for NP incorporating disease-related variables (e.g., stage of disease, location of tumor), treatment variables (chemotherapy, dose, duration; and other cancer therapy), clinical health status (e.g., comorbid conditions), and sociodemographic characteristics (e.g., age, sex, race).
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Cielito C. Reyes-Gibby, DrPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535067
- Sponsor's protocol ID
- 2006-0761
- Status last verified
- Jan 2015
- First submitted
- 21 Sep 2007
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropathic Pain in Survivors of Breast Cancer
- ClinicalTrials.gov ID
- NCT00535067
- Acronym / sponsor ID
- 2006-0761
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Questionnaire, Survey, Neuropathic Pain, Cancer Survivors, Quality of Life, QOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Sep 2007
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Sep 2007 (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.
The objectives of this study are to: 1) describe the prevalence of neuropathic pain (NP) in breast cancer survivors and 2) to develop preliminary statistical risk models for predicting the risk for NP incorporating disease-related variables (e.g., stage of disease, location of tumor), treatment variables (chemotherapy, dose, duration; and other cancer therapy), clinical health status (e.g., comorbid conditions), and sociodemographic characteristics (e.g., age, sex, race).
Researchers will also gather data to answer the following secondary aims:
- To assess the impact of NP on quality of life.
- To assess the current management of NP in cancer (current medication, duration of such treatment, reasons for discontinuation) and the outcomes of this management.
Detailed description
You have already been contacted by phone about participating in this study. You have received study documents (this consent and the study questionnaires) because you said over the phone that you would like to participate in this study.
In this study you will be asked to complete questionnaires that will ask about any pain you may be experiencing and about the quality of your life. These questionnaires will also ask for demographic information (such as age, race, and sex) and about your health. It should take about 1 hour to complete all of the questionnaires. In addition to the questionnaires, you will also be asked questions about any medications you may currently be taking for pain. All of the information you include on the questionnaires will be kept confidential. There are no right or wrong answers to the questions. A postage-paid return envelope has been provided for you to return this consent and the questionnaires.
Researchers are interested in how pain is related to certain treatments and medical conditions. As part of this study, researchers will review your medical records to see what type of cancer treatment you received and whether you had any pain related to the treatment. They will also see if you had any non-cancer health conditions that may have affected pain and quality of life.
This survey is for research purposes only. Your healthcare provider will not be informed of your responses to this survey. If you are experiencing severe pain and/or other symptoms, please contact your healthcare provider. The study staff has also included a list of community resources that you may contact for different types of services.
Your participation in this study will be over once you mail back the consent and questionnaires.
This is an investigational study. Up to 635 individuals will be asked to take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Survivors | – | Behavioral: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast Cancer survivors.
Key inclusion criteria (3 listed)
- Breast cancer patients who were participants in clinical trials (ID98-240; ID94-002) for taxanes during 1994-2001
- Alive and with current contact information
- Age ≥ 18 years. (This restriction is based on inclusion criteria for the clinical trials from which subjects will be recruited. All patients will be at least 18 years or older for this study.)
Key exclusion criteria (1 listed)
- 1) None
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 |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaires taking 60 minutes total to complete. | Behavioural | Breast Cancer Survivors |
Primary outcome
Prevalence of neuropathic pain (NP) in breast cancer survivors
Time frame: 3 Years
Assessment of neuropathic pain will be standardized using two validated tools for this purpose: the self report version of the LANSS pain score (S-LANSS) [Bennett 2001, Bennett et al 2004] and ID Pain (IDP) [Portenoy, et al, 2006]. The S-LANSS is a 7-item instrument that identifies pain of predominantly neuropathic origin. A score of 10 or more (out of a maximum of 24), regarded as a "positive" score, identifies neuropathic pain with a sensitivity, specificity and positive predictive value all of 80%. It has been found to be valid and reliable in both clinical and mail-survey settings [Bennett et al 2004]. The IDP is a 6-item scale that assesses the quality of pain, and has been well-validated [Portenoy, et al, 2006].
1 secondary outcome
Study of how much pain, factors related to the pain, and how the pain affects life
Time frame: 3 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Cielito C. Reyes-Gibby, DrPH principal investigator
M.D. 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 Breast 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 9 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of neuropathic pain (NP) in breast cancer survivors (time frame: 3 Years). 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 9 Jan 2015.