Neuropathic Pain in Survivors of Breast Cancer

NCT00535067 | Completed

• 1 other identifier: 2006-0761
• Study Type: observational
• Target: 239
• Locations: 1 country
• Sites: 1

Brief 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 (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:

1. 1.To assess the impact of NP on quality of life.
2. 2.To assess the current management of NP in cancer (current medication, duration of such treatment, reasons for discontinuation) and the outcomes of this management.

Conditions

Breast Cancer

Keywords

Breast Cancer; Questionnaire; Survey; Neuropathic Pain; Cancer Survivors; Quality of Life; QOL

Outcome Measures

Primary Outcomes (1)

• 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 \[Portenoy, et al, 2006\].

  3 Years

Secondary Outcomes (1)

• Study of how much pain, factors related to the pain, and how the pain affects life

  3 Years

Study Arms (1)

Breast Cancer Survivors

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Questionnaires taking 60 minutes total to complete.

Also known as: Survey

Breast Cancer Survivors

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

Breast Cancer survivors.

You may qualify if:

• Breast cancer patients who were participants in clinical trials (ID98-240; ID94-002) for taxanes during 1994-2001
• Alive and with current contact information

You may not qualify if:

• \) None

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Pfizer: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Neuralgia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

• Cielito C. Reyes-Gibby, DrPH

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 21, 2007
• First Posted: September 26, 2007
• Study Start: September 1, 2007
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 9, 2015

Record last verified: 2015-01

Locations

US (1)