Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer
The first goal of this study is to learn more about the experience of pain and other symptoms in men being treated for advanced prostate cancer. The second goal of the study is to identify reliable ways of measuring pain which will be used in future clinical trials of treatments for advanced prostate cancer.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer|
- pain score [ Time Frame: 2 years ] [ Designated as safety issue: No ]Pain score changes will be correlated with each of the following: patient rating of change in pain, as well as changes in patient functional status, analgesic use, and various measures of disease status (imaging, PSA, circulating tumor cells). The distribution-based approach is to estimate meaningful change as one-half a standard deviation of the sample mean pain score.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
assessments completed by patients
A single-arm observational study will be conducted at three institutions in the Prostate Cancer Clinical Trials Consortium (PCCTC): Memorial Sloan-Kettering Cancer Center; Johns Hopkins; and Oregon Health & Science University. MSKCC is the coordinating center. The target enrollment is 400 patients, with at least 250 experiencing "moderate or worse" pain intensity at baseline, defined as a score of ≥4, the preferred regulatory cutoff.
Behavioral: Webcore telephone survey system
Patients will report pain and analgesic use through the automated telephone system, for 7 days in a row, once every 6 weeks. Data from diagnostic tests (CT Abdomen/Pelvis, Bone Scan, PSA, and circulating tumor cells) conducted during the study period will be collected from medical records by local personnel and entered into the secure online database quarterly, but no specific tests or schedules will be required in this observational study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617174
|Principal Investigator:||Michael Morris, MD||Memorial Sloan Kettering Cancer Center.|