Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01617174|
Recruitment Status : Withdrawn
First Posted : June 12, 2012
Last Update Posted : November 8, 2013
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Behavioral: Webcore telephone survey system|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||June 2014|
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.
- pain score [ Time Frame: 2 years ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617174
|Principal Investigator:||Michael Morris, MD||Memorial Sloan Kettering Cancer Center|