Decision Making in Men With Early Stage Prostate Cancer Patients and Partners/Close Allies
The purpose of this study is to collect information on how patients and their partners/close allies make treatment decisions when they have been diagnosed with early stage prostate cancer.
|Study Design:||Observational Model: Family-Based
Time Perspective: Prospective
|Official Title:||Decision Making in Men With Early Stage Prostate Cancer Patients and Partners/Close Allies|
- evaluate the impact of anxiety and the inability to tolerate ambiguity [ Time Frame: 2 years ] [ Designated as safety issue: No ]on the decision making process in men with prostate cancer who are eligible for active surveillance and their partners/close allies. All participants will be administered a set of questionnaires that assess psychological and affective functioning, and treatment preferences.
- how partners/close allies influence the decision making process [ Time Frame: 2 years ] [ Designated as safety issue: No ]participants will be administered a set of questionnaires that assess psychological and affective functioning, and treatment preferences.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
|early stage prostate patients & their partners/close allies||Behavioral: assessments|
Each patient and his partner will fill out assessments at baseline. Thereafter we will obtain the patients' treatment decision (AT or AS) within approximately 3 months. Once a patient makes a decision, he and his partner will complete another set of questionnaires. The patient and his partner will then complete the remaining questionnaires approximately 6, 12, 18, and 24 months following the treatment decision. We will examine the associations between baseline assessments , and the treatment decision as well as the changes in the assessments and the treatment decision. We will also assess associations between follow-up assessments and the decision to change a treatment decision from AS to AT. Data from patients and partners/close allies will generally be analyzed separately, thus patients who do not have a partner (or partner declines to participate) can still be enrolled and their psychosocial outcomes assessed.
We will also schedule interviews with approximately 66 patients and 36 partners/close allies to obtain the themes and subthemes of their decision-making. Those invited for interviews may or may not be from the same day.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01877070
|Contact: Christian Nelson, PhD||646-888-0030|
|Contact: Andrew Roth, MD||646-888-0024|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Christian Nelson, PhD 646-888-0030|
|Contact: Andrew Roth, MD 646-888-0024|
|Principal Investigator: Christian Nelson, PhD|
|Mount Sinai Hospital||Completed|
|New York, New York, United States, 10029|
|Principal Investigator:||Christian Nelson, PhD||Memorial Sloan Kettering Cancer Center|